The INSPIRE Foundation's Past Projects
1 – The Freehand System
The Freehand System
Salisbury, Award: c £400,000, Start of Trial: 6 Jun 95
The Freehand System is an implanted FES (Functional Electrical Stimulation) device intended for the restoration of hand function in C5 and C6 level tetraplegics.
Following training and gaining the necessary clearances, the first Freehand at a cost of $24,000 (about £16,800) was implanted and is still being used today. The user would proudly tell you that he is now able to open a bottle of wine! INSPIRE was authorised by the then MDA (Medical Devices Agency) to implant 20 systems and it was agreed that the Spinal Unit at Southport should do three and Salisbury 17. In fact the overall total would have been more because Scotland purchased two but the American company responsible for making and distributing the Freehand ran into financial difficulties during 2001 and all operations relating to Freehand stopped. INSPIRE never completed its trial (16 were implanted) and it was a cruel blow to hit C5/C6s, some of whom were looking forward to being given the device.
INSPIRE remains keen to continue with the ‘son’ of Freehand but there have been complications in the US, some relating to the recovery of IPR. This has now been done and the system has been redesigned, improved and should offer more functions such as bladder management or offered to C4s. The first implant of this new system is expected by the end of 2007 in the States.
European agencies are looking at producing their own version.
2 – A Pilot study of lower limb FES cycling in paraplegia
A Pilot study of lower limb FES cycling in paraplegia
Glasgow University, Award: £3,886, Date of Award: 15 Mar 00
The objective of the study was to achieve regular periods of FES cycling in three volunteer paraplegic subjects. This would form the basis for a long term study into the effects of FES cycling exercise and the feasibility of recreational cycling.
Effectively, this trial was Phase 1 the data gained was used in a subsequent application for Phase 2.
3 – Investigation of Long Pulse Electrical Stimulation of long term denervated muscle in humans to evaluate therapeutic and functional benefits
Investigation of Long Pulse Electrical Stimulation of long term denervated muscle in humans to evaluate therapeutic and functional benefits
Salisbury, Award: £3,000, Date of Award: 1 Jun 00
The objective of this study was to investigate the effect of a 12 month programme of electrical stimulation of denervated quadriceps muscle in humans using Long Pulse, Biphasic pulses and surface electrodes. Outcome measures of limb girth, muscle depth and limb blood flow were used as well as the minimum pulses widths required to produce muscle innervation.
The changes observed following long pulse stimulation appeared to be more therapeutic than functional. Clear improvements in the strength-duration characteristics of denervated muscle following long pulse stimulation were observed although there were no obvious functional benefits from this. While a trend towards improvement in muscle depth was noticed in Subject D, and the subject commented on this himself, this trend was not observed in other subjects.
All of the subjects in the trial commented that Long Pulse Electrical Stimulation had an effect on their sensation of pain. Given the high priority that people with SCI place on research into the possible reduction of pain this is an area that may be worth further exploration.
Extract taken from End of Project Report
4 – Lumbar Anterior Root Stimulator Implants (LARSI)
Lumbar Anterior Root Stimulator Implants (LARSI)
University College London, Award: £14,721, Date of Award: 1 Jun 00
The original aim of LARSI was to assist with standing unfortunately, although leg actions in response to stimulation were understood in detail, hip flexion and adduction severely limited this ability. However, a sufficiently accurate muscle response model was found to give successful cycling in a recumbent tricycle.
This application is for the support of the Research Fellow (40% FTE) involved on the project.
The information gained from this project was used to submit another application (see below) Developing FES-cycling for health and recovery after spinal cord injury (UCL)
5 – A two centre randomised controlled trial to investigate the use of Botox A in upper limb spasticity in tetraplegia
A two centre randomised controlled trial to investigate the use of Botox A in upper limb spasticity in tetraplegia
Southampton University, Award: £12,700, Date of Award: 8 Mar 01
Botulinum Toxin A (BTXA), when injected intramuscularly prevents the release of acetylcholine at the neuromuscular junction, causing loss of communication between nerve and muscle. This randomised controlled trial of people with cervical spinal cord injury will measure the effect of BTXA on function and spasticity. BTXA has been shown to bind with active motor units. By passively stretching the spastic muscle immediately after injection, the stretch sensitive (spastic) motor units will be activated but not those that are either paralysed or under normal voluntary control.
This study will test this novel technique to improve the reduction of spasticity without compromising muscle strength.
The project progressed very slowly due to a lack of suitable subjects. Subsequently, a different recruiting strategy was introduced but only 2 volunteers came forward. This project was unsuccessful.
6 – A Pilot study of lower limb FES cycling in paraplegia – Phase 2
A Pilot study of lower limb FES cycling in paraplegia – Phase 2
Glasgow University, Award: £5,000, Date of Award: 13 Aug 01
This follows on from a pilot study on lower limb FES cycling (Phase 1 see above) in which three subjects with a complete spinal cord lesion at level T7-T10 were able to cycle continuously and reliably on a cycle trainer for periods of up to 40 minutes. The subjects were also able to achieve mobile cycling outside, for distances of up 2.4km.
In this phase of the pilot study the work extended the work done in Phase 1 by:
(i) refining and systematically testing our novel methods for automatic control of FES cycling;
(ii) performing FES-cycling exercise test to establish a scientifically-validated methodology for documenting changes in cardiopulmonary fitness in SCI subjects.
7 – Developing FES-cycling for health and recovery after spinal cord injury
Developing FES-cycling for health and recovery after spinal cord injury
University College London, Award: £10,000, Date of Award: 13 Aug 01
The long term goal is to produce a lumbo-sacral nerve root stimulator system for thoracic paraplegics which can be used for bladder/bowel control and cycling exercise. FES-cycling may alleviate some of the ill-health, following spinal cord injury. The implant will make cycling more convenient to use than surface-electrode systems. The medium term goal is to carry out an EPSRC-funded project to demonstrate these health benefits.
This application is to allow the Research Fellow involved on the project to carry out three tasks which will help develop FES-cycling for wider use and facilitate the health study. These tasks are: to develop better electrode trousers; to begin the design of a stimulator for FES-cycling which gets approval from the regulator; and to complete current pilot work with four FES-cyclists.
This was a successful pilot study which led to a successful application to EPSRC to fund a multi-national study.
8 – Virtual reEmbodiment (VrE) as a treatment for chronic deafferentation pain in subjects with Spinal Cord Injury
Developing FES-cycling for health and recovery after spinal cord injury
University College London, Award: £10,000, Date of Award: 13 Aug 01
The long term goal is to produce a lumbo-sacral nerve root stimulator system for thoracic paraplegics which can be used for bladder/bowel control and cycling exercise. FES-cycling may alleviate some of the ill-health, following spinal cord injury. The implant will make cycling more convenient to use than surface-electrode systems. The medium term goal is to carry out an EPSRC-funded project to demonstrate these health benefits.
This application is to allow the Research Fellow involved on the project to carry out three tasks which will help develop FES-cycling for wider use and facilitate the health study. These tasks are: to develop better electrode trousers; to begin the design of a stimulator for FES-cycling which gets approval from the regulator; and to complete current pilot work with four FES-cyclists.
This was a successful pilot study which led to a successful application to EPSRC to fund a multi-national study.
9 – Stimulation of the Gluteal Muscles to increase muscle bulk and reduce seating pressures
Virtual reEmbodiment (VrE) as a treatment for chronic deafferentation pain in subjects with Spinal Cord Injury
Bournemouth University, Award: £7,500, Date of Award: 18 Mar 02
This project aims to test the hypothesis that by using Virtual Reality to ‘visually restore’ impaired limbs, the intractable deafferentation (or phantom) pain associated with the neurological loss will also be removed. A three dimensional environment will be constructed in which the subject can interact using their ‘virtual limb’ moved by the subject using their remaining movement on the affected limb or shoulder. Once this virtual arm is inhabited by the subject, or elaborated into their motor self, it is expected that they will experience a reduction in pain.
The data gained from this INSPIRE funded pilot trial helped the Principal Applicant to make a successful application to the Wellcome Foundation
Further Report from the Principal Applicant
As of 15 January, 2007, have now performed experiments with 6 patients with forelimb amputations and 6 with hind limb who have phantom limb pain. In 4 of the 6 patients with arm amputations we found an effect in that they were able to feel the virtual arm was their arm and that they were moving it. They felt sensation in the virtual arm too and with that their pain reduced, from VAS scores of 7-8 to 0-4. However the other two subjects were not able to move the virtual arm as their own and had no effect on the pain. This latter may be down to both of these patients having several years each before amputation when their real arms were immobile before amputation. Unfortunately we were unable to recruit any more people than 6 with forelimb amputations and so built a virtual leg which we have just started to test on patients in Oxford.
Of these 6 we have only found an effect in 2. We are continuing this work with more patients and working on a system which can be taken home and so used chronically rather than in the lab in acute situations.
You might be interested to know that in addition to some similar work being done in Trinity College Dublin, where their funding seems to have been an issue, there is a similar project underway in Manchester, though with a slightly different approach. I am meeting both groups next week.
So our work continues albeit slowly, since none of us are full time on it, and the results for the arm at least are encouraging. The project and idea is not too far removed from the Liverpool work INSPIRE has been asked to support. What is less encouraging, though it is early days, is that 2 of the people with leg amputations were able to move their phantom easily (in the imagination) but in one this made the pain worse and in another had no effect on it.
10 – A model of the infected urinary tract for testing bio-materials Award: 29 Aug 03 Date of Award: £30,000
Stimulation of the Gluteal Muscles to increase muscle bulk and reduce seating pressures
Salisbury, Award: £8,000, Date of Award: 18 Mar 02
Compared with the general population, people with spinal cord injury have been classified as a high risk group for developing a pressure sore. Evidence suggests that up to 85% will develop a sore at some point in their life.
This pilot study will investigate the effects of using electrical stimulation to increase the muscle bulk. It is suggested that by increasing the muscle bulk there will be significant reduction in seating pressures
There was great difficulty in recruiting 15 volunteers and in the end only 4 finished the trial of whom 3 did not follow the protocol.
11 – Preparing for a clinical trial of SLARSI (Sacral lumbar anterior root stimulator implant)
A model of the infected urinary tract for testing bio-materials
University College London – Institute of Urology and Nephrology), Award: 29 Aug 03, Date of Award: £30,000
Encrustation of urological devices is worsened in the presence of infection and complications cost in excess of 1 billion Euros in the European Union and a similar amount in North America.
The objective of the project was to validate an in vitro model to quantify encrustation (stone deposits) on urinary devices (bladder catheters and ureteric stents) in the presence of urine infection in spinal cord injured patients.
Encrustation of urinary catheters and ureteric stents causes bleeding, infection, pain and blockage of the bladder or kidney. A blocked catheter or stent leads to severe pain and distress to the patient and needs to be replaced as an emergency. Infection of catheters and stents is common in spinal cord patients and in the presence of an obstruction can be life threatening.
Validation studies using human urine to quantify encrustation in the presence of urine infection has not been done before. Human urine contains essential substances such as urinary proteins, which play an important role in encrustation. These proteins are lacking in artificial urine, which does not reflect either true or physiological state of human urine.
A number of obstacles were overcome during the study. Microbiological advice was sought right from the start and the appropriate bacteria obtained for the study. Microbiological training took place to conform to health and safety regulations. New microbiological training was given to perform bacterial counts for the experiments. The in vitro model was designed to reflect an infected bladder by voiding urine more frequently than a non-infected bladder. Difficulties were encountered to ensure the test medical device and the control device received urine simultaneously and at the same rate. These were overcome. There were problems with atomic absorption spectroscopic measurement of encrustation on the medical devices and these were overcome.
The in vitro model for testing encrustation in infected urine has now been validated to provide reproducible results for quantifying encrustation on medical devices. This is an important step in the study and understanding of this recurrent and difficult problem faced by spinal cord injured patients who need long term catheters or a urinary implant such as a ureteric stent. With this validated in vitro model, different urological devices can be quantified for its potential to encrust and cause blockage. It also provides a useful tool to study and potential new biomaterial or medical device designed for patients with spinal cord injury. We are extremely grateful to INSPIRE for the support to carry out this work.
12 – Reducing muscle fatigue induced by Functional Electrical Stimulation in Spinal Cord Injury: a pilot study
Preparing for a clinical trial of SLARSI
University College London, Award: £44,000, Date of Award: 17 Sep 04
The Sacral Anterior Nerve Root Stimulator is the well-established method for restoring bladder function after complete spinal cord lesion. We have shown that Lumbar root stimulation can be used for exercising all the paralysed leg muscles, and may be used for cycling. We are developing an implant for sacral and lumbar root stimulation with the primary purpose of bladder/bowel function but also for leg exercise and possible recreational cycling. The aim for this application is to prepare for a clinical trial.
As at the beginning of 2007, there has been a difficulty in recruiting volunteers for SLARSI so the team is working at present on an implant inspired by Mike Craggs (Stanmore) which, if successful, will restore urinary continence and bladder emptying (and more) without a rhizotomy. To do this requires a rechargeable battery, a means to recharge it, a 2-way radio link, but it is perceived to be more complicated than SARSI and SLARSI.
This project is on hold until a decision has been taken as to which system should be adopted.
13 – A systematic exploration of Neuromuscular Electrical Stimulation in Spinal Cord Injury: Users’ perspectives of current and future use
A systematic exploration of Neuromuscular Electrical Stimulation in Spinal Cord Injury: users’ perspectives of current and future use
Southampton University, Award: £79,776, Date of Award: 8 Dec 05
For nearly half a century Neuromuscular Electrical Stimulation (NMES) has been used in the treatment and management of physical problems encountered by people with SCI. Applications have encompassed bladder and bowel control, pain, movement, tissue viability and musculoskeletal and cardio-respiratory function. Techniques have been developed, evaluated and in some cases commercialised, yet currently reach only a small fraction of the SCI community. While techniques have evolved to be more effective and technically sophisticated they have often undergone phases of great popularity followed by periods of rejection. Popularity has often been associated with highly active research groups and faded with loss of funding of research or a failure to achieve technology or clinical transfer. There is a dearth of good clinical evaluation partly because of small patient numbers.
Those who have been involved with the clinical use of NMES have little doubt of its potential to improve the lives of people with SCI, yet are frustrated by the apparent inability to transfer research into clinical practice. We therefore must question whether we can ignore the opinions of the people involved – people with SCI, their families and healthcare professionals; both those who do and those who do not use NMES. The perspective of these groups is vital in directing research, developing NHS services, and driving commercialisation. In order to gain an understanding of the perspective of people with SCI, their partners, healthcare professionals and researchers a specific research approach needs to be employed.
14 – A randomised trial of rectal stimulants for neurogenic bowel management after spinal cord injury
A randomised trial of rectal stimulants for neurogenic bowel management after spinal cord injury
NSIC Stoke Mandeville, Award: £28,439, Date of Award: 9 Aug 06
Neurogenic bowel dysfunction is a major problem to spinal cord injured (SCI) individuals. It has a significant impact on quality of life and contributes to long term morbidity.
Rectal stimulation is used by many SCI individuals with reflex bowel function and is used specifically to trigger bowel evacuation at a chosen time. Pharmacological rectal stimulants have a direct effect on the speed and efficiency of evacuation, which in turn have a significant effect on the quality of life of SCI individuals. However, there is little evidence regarding efficacy and side effects. It is not known which stimulants might reduce the requirement for interventions such as ano-rectal stimulation and manual evacuation of stool.
A multi-centre randomised trial is proposed to address these issues.
15 – Optimising power output during electrically stimulated cycling in people with a spinal cord injury
Optimising power output during electrically stimulated cycling in people with a spinal cord injury
Kings College London – School of Biomedical & Health Sciences, Award: £52,025, Date of Award: 30 Aug 06
Electrically stimulated cycling (ESC) enables people with a spinal cord injury to participate in recreational and competitive exercise and gain the associated health-related and psychological benefits.
We have been studying the effects of ESC training over a one year period and the results have revealed a number of issues that need to be addressed if the benefits of ESC are to be optimised. While the subjects became much stronger, the power output achieved was less than expected from the muscle strength and sufficient only to allow cycling indoors on a smooth, flat surface. Although muscle fatigability improved, the subjects showed a marked loss of power output after only a few minutes of cycling. There are a number of possible causes for these findings and we propose a series of linked experiments to explore ways in which power output during ESC can be improved and maintained in order to optimise cycling ability
16 – Improving the efficiency of electrically stimulated cycling
Improving the efficiency of electrically stimulated cycling
Kings College London – School of Biomedical & Health Sciences, Award: £33,708, Date of Award: 15 Mar 07
This is a continuation of the previous trial (No 15)
17 – Central nervous system reorganisation after spinal cord injury: its relationship to pain and response to mental imagery
Central nervous system reorganisation after spinal cord injury: its relationship to pain and response to mental imagery
Pain Research Institute Liverpool, Award: £35,264, Date of Award: 15 Mar 07
We have shown in people with phantom limb pain that regularly practised mental imagery reduces phantom pain and sensory and motor cortical reorganisation. Using functional Magnetic Resonance Imaging (fMRI), we now wish to investigate the cerebral correlates of spinal cord injury (SCI) and SCI pain; the effects of imagined movement of and sensation in paralysed limbs on pain and cortical and thalamic neuroplastic changes, and any association between the two.
Study design: pilot study: 5 people with stable SCI and pain, 5 people without pain, and 5 healthy volunteers will participate. Participants will initially undergo fMRI scans during a series of tasks to measure the effects of SCI on cerebral activation. We hypothesise that those with pain will show more extensive functional reorganisation. Following training in mental imagery, the scans will be repeated. We hypothesise that this training will relieve SCI pain and reduce neuroplastic changes.
18 – Cycling Therapy for incomplete spinal cord injury (UCL)
Cycling Therapy for incomplete spinal cord injury
University College London, Award: £18,791, Date of Award: 22 Aug 07
FES cycling has been found to improve voluntary function in one person with incomplete SCI. As a possible therapy, FES cycling offers the great advantage compared with treadmill- or Lokomat-walking, that it could be relatively low-cost and could be done often at home. We intend to carry out a study with 20 subjects, to compare FES cycling with passive cycling, in which the pedals are moved by a motor. We want to know how many subjects show improved walking, and the relative effect of passive versus active movement.
This is a grant application to develop instrumented cycling machines in preparation for the trial.
19 – The short-term efficacy of Sacral Nerve Stimulation (SNS) in patients with neurological constipation
The short-term efficacy of Sacral Nerve Stimulation (SNS) in patients with neurological constipation.
Durham University, Award: £31,750, Date of Award: 13 Feb 08
Introduction: Patients with spinal disease often suffer from constipation. Routine treatments are usually ineffective leading to a reduced quality of life. SNS offers a minimally invasive and safe alternative in such situations but there have been no studies on its efficacy yet.
Hypothesis: Patients suffering from refractory neuro-constipation will benefit from SNS.
Methods: 30 patients with refractory neuro-constipation recruited to twelve week within-group study. The study will include data collection during three phases of study using diary cards, self-administered questionnaires, transit times and laser doppler flowcytometry. As the study is uncontrolled and unblinded, transit time and laser doppler flowcytometry will provide important physiological evidence about the efficacy.
Conclusion: This study will provide valuable information regarding the role of SNS in these patients and its application in clinical practice. As a proof of concept study it will award impetus for future research projects involving the use of SNS in neurological constipation.
20 – Central nervous system reorganisation after spinal cord injury: its relationship to pain and response to mental imagery
Central nervous system reorganisation after spinal cord injury: its relationship to pain and response to mental imagery
Pain Research Institute Liverpool, Award: £76,100, Date of Award: 12 Mar 09
This is the full clinical trial. The results so far do seem to show that the brain does try to reorganise itself following spinal cord injury and for many who suffer from deafferentation (phantom) pain the mental therapy does give relief.
21 – The Effect of functional electrical stimulation-assisted rowing on cardio-respiratory function in persons with spinal cord injury
The Effect of functional electrical stimulation-assisted rowing on cardio-respiratory function in persons with spinal cord injury
Brunel University, Award: £12,000, Date of award: 12 Mar 10
Not supported by Scientific Committee – lack of funds.
To be re-submitted March 2011
22 – rTMS Therapy for promoting continence in incomplete spinal cord injury (Stanmore and Imperial College London)
rTMS Therapy for promoting continence in incomplete spinal cord injury.
RNOH Stanmore and Imperial College London, Award: £39,723, Date of Award: 13 Aug 10
A Project to establish the feasibility of using repetitive magnetic stimulation on an area of the brain to promote continence in people who have an incomplete spinal cord injury
This project is on-going.
23 – Bimanual Coordination after Incomplete Cervical Spinal Cord Injury. Pilot Study
Bimanual Coordination after Incomplete Cervical Spinal Cord Injury. Pilot Study
University of Leeds, Centre for Sport & Exercise Sciences, Amount requested: £39,363, Jan 2012
People who have suffered an incomplete cervical spinal cord injury (iSCI) demonstrate difficulties with moving their arms and hands and highlight restoration of arm and hand function as a major priority for research. Clinical evidence shows that bimanual therapy may be more effective than unimanual therapy however to date little research has examined how the two limbs interact during bimanual tasks. Published work shows that one way to overcome the difficulties associated with performing bimanual tasks is to couple the limbs spatially and temporally and that the degree and nature of this is dependent upon task characteristics. This study will examine how individuals with a cervical (C5-C7) incomplete spinal cord injury reach and grasp objects bimanually. Five different experimental tasks will examine the effect of the objects’ distance, height, size, friction, stability on underlying control strategies that will be assessed using a kinematic recording device and surface electromyography.
Considered by the Scientific Committee 12 JUN 2012 ‘..interesting but ambitious..’ and ‘…first aim was enormous ..doubtful if the objectives could be achieved ..’
NOT RECOMMENDED
24 – Effect of FES assisted rowing on cardio-respiratory function in persons with SCI
Effect of FES assisted rowing on cardiorespiratory function in persons with SCI
Brunel University, Award: £12,000 Sept 2010, Final Report 1st February 2012
To determine whether there are significant cardiorespiratory differences between people with a spinal cord injury who have engaged in moderate intensity FES-rowing and those who have remained sedentary.
25 – Prospective study comparing how different levels and degrees of completeness of SCI affect recto-anal reflexes and how this influences anorectal function and continence
Prospective study comparing how different levels and degrees of completeness of SCI affect recto-anal reflexes and how this influences anorectal function and continence
rTMS 10-01
Royal National Orthopaedic Hospital, ImperialCollegeLondon, UniversityCollegeLondon, Award: £39,723, Date: 13 Aug 2010
Control of the urinary bladder and sphincters relies on the integrity of spinal pathways to coordinate proper function. Following supra-sacral spinal cord injury, coordination fails and aberrant sacral reflexes, bladder hyper reflexia and sphincter dyssynergia emerge. Recently we have shown that modulation of the sphincter “guarding reflex”, measured by the pudendo-anal reflex during bladder filling and emptying, is a sensitive and reliable measure of dyssynergia. Preliminary studies have also shown that the reflex is facilitated by single pulse transcranial magnetic stimulation (TMS) of cerebro-spinal pathways in control subjects with weaker modulation in incomplete spinal cord injury.
We hypothesise that by using focal repetitive transcranial magnetic stimulation (rTMS) of residual corticospinal pathways in incomplete spinal injury we can promote positive plastic changes which will facilitate the “guarding reflex” and help reduce both urinary and faecal incontinence.
26 – TETRAGRIP: Development of a FES Device for hand function in incomplete tetraplegia
TETRAGRIP
Development of a FES Device for hand function in incomplete tetraplegia
TETRA G 01-12
Salisbury District Hospital /Bournemouth University, Amount requested 3 year studentship at £7,500 p.a. = £22,500, Oct 2012
Research has demonstrated that FES based training devices can lead to improved hand and am function following spinal cord injury. However, there is a need to develop an improved device and control techniques to enable routine use outside the clinical setting, This PhD project will aim to produce a system that can be easily used by people with a range of ability following tetraplegia.
New stimulation techniques using ‘current steering’ will be used to automatically fine tune the movement produced, removing variations due to electrode position, fatigue and spasticity. While the principle use of the device will be for training hand function, it is envisaged that it may also be used as a long-term orthosis. A feasibility study/clinical trial will be used to demonstrate the device in clinical use. The principle goal is to increase the functional independence of people with C5, C6 or C7 incomplete tetraplegia.
27 – Development of an epiduroscope with radiation-free navigation assistance and neural activity detection capabilities
Development of an epiduroscope with radiation-free navigation assistance and neural activity detection capabilities
St Andrews, Application: 37,000, Nov 2012
The possibility to safely access the spine with a small endoscope would enable a disruptive approach to the treatment of correlates of spinal injuries.
Yet, to the present day, spinal endoscopy (epiduroscopy) suffers from severe drawbacks. In particular, epiduroscopes are very small, and the consequent poor image quality mandates the use of continuous x-ray to guide them into and through the spine. The consequent exposure of the patient to very high x-ray doses does not allow the use of this potentially revolutionary tool on a systematic basis. We have recently demonstrated a technique to derive the position of a spinal catheter using photonic technologies, which do not expose the patient to harmful radiation. This project is aimed at using this technique to build a full featured prototype of an epiduroscope capable of safe navigation without the assistance of x-rays, including pre-clinical functional tests.
Considered by the Scientific Committee 12 JUN 2012 who believed there was an over emphasis on the danger from radiation. Further this was not specifically linked to SCI.
NOT RECOMMENDED
28 – Development and testing of an ERGOMETER for and experiment in functional recovery after spinal cord injury
Development and testing of an ERGOMETER for and experiment in functional recovery after spinal cord injury
UCL/Southampton/RNOH Stanmore, Application: £14,095, Sep 2012
A cycling exercise machine is being designed with associated electric motor and electronics. The machine will be used with a commercial virtual reality racing game and a remote monitoring device. The design will allow us to do an experiment that tests the hypothesis that is the combination of electrical stimulation and voluntary drive to the paretic muscles that has the best therapeutic effect, seen in improved walking ability. This grant will fund the development of a prototype and tests with volunteers at the RoyalNationalOrthopaedicHospital prior to our application for another grant to perform a proof of concept and feasibility study on a larger group of subjects./ Students are doing most of the development, but this initial grant will pay for parts, materials and technician time. If the experiment gives a positive result, the system will be suitable for clinical use.
Considered by Scientific Committee 12 Jun 2012. Funding approved by the Board of Trustees 15 Aug 2012.
29 – Developing a virtual reality visualisation tool to extend the benefits of mirror therapy to patients with spinal cord injury
Developing a virtual reality visualisation tool to extend the benefits of mirror therapy to patients with spinal cord injury
Portsmouth, Jan 2013
Visualisation of movement in virtual reality has been demonstrated to have the potential to be used for the treatment of pain and motor dysfunction. However, it is currently limited to use with patients who have an intact and functioning limb at the same level as the impaired or missing limb. This project aims to develop a Virtual Reality tool to support the treatment of phantom pain in spinal cord injured patients. Applying the principles of mirror box therapy, the project will use spiking neural networks to develop a computational model for motion prediction, extending the current capacity of the virtual mirror box to enable simulation of the movement of any impaired limb from any unimpaired limb. The computational models developed in this project will offer a tool which will extend the known benefits of mirror therapy and motor visualisation for use in patient groups previously unable to access this type of treatment.
NOT RECOMMENDED by the Scientific Committee 12 Jun 2012. Applicant was invited to resubmit at the next round and demonstrate a `…positive benefit to the SCI.’
30 – Hospital and home-based feasibility study of an iCycle for functional recovery after incomplete spinal cord injury
Hospital and home-based feasibility study of an iCycle for functional recovery after incomplete spinal cord injury
Southampton, Cost 38,057.80, Oct 2013
Neuroscience research that has identified potential for recovery (neuroplasticity) following incomplete SCI has changed clinical practice away from compensation strategies towards optimizing recovery. Important factors include: repetitive exercise, Functional Electrical Stimulation (FES) and appropriate feedback. The iCycle combines repetitive exercise with FES and provides feedback on performance in a virtual cycle race. Unlike previous devices, performance in the race is determined only by voluntary effort (i.e. not torque generated by FES plus voluntary effort). In this study with incomplete SCI participants we will test the iCycle with six inpatients to refine the protocol and make technical improvements. We will then conduct an ABA pilot study (n=10) in which a 3G-connected iCycle is used in people’s own homes. We will compare usual care (A) with iCycle exercise (B). Changes in neural connectivity (TMS evoked EMG potentials), muscle strength and walking will be measured as well qualitative analysis of users’ views.
31 – The feasibility of FES rowing in spinal cord injury: can the pattern of leg loading increase bone density?
The feasibility of FES rowing in spinal cord injury: can the pattern of leg loading increase bone density?
Brunel University London, Award: £20,590, Date of Award: Mar 2013
A repeated measures design series case study was used to investigate the effect of long-term multi-channel FES-rowing training on lower limb trabecular bone mineral density (BMDt) compartments of individuals with complete spinal cord injury (SCI)
32 – Neuromodulation as an alternative to pharmaceutical therapies for bladder, bowel & lower limb spasticity in SCI: NEUROMOD incorporating: Patient focused development of a versatile, externally-worn stimulation-occlusive device to control urinary incontinence in spinal cord injury. This project became NEUROMOD I
Neuromodulation as an alternative to pharmaceutical therapies for bladder, bowel & lower limb spasticity in SCI: NEUROMOD incorporating: Patient focused development of a versatile, externally-worn stimulation-occlusive device to control urinary incontinence in spinal cord injury. This project became NEUROMOD I
London Spinal Cord Injury Centre at the Royal National Orthopaedic Hospital, Stanmore & University College London, Award: £85,595, Date of Award: Nov 2014
Restoration of bladder and bowel function is a top priority for patients who have suffered a life changing spinal cord injury. Appropriate patient-focused bladder and bowel management approaches reduce morbidity and improve quality of life. Pelvic functions are controlled by complex interactions between voluntary and autonomic nervous systems, at both brain and spinal reflex levels. Following SCI these Neuromodulation (electrical stimulation of neural pathways to modify their activity) of the sacral nerves can be effective at inhibiting these unwanted reflexes.
We propose to expand on our previous work in this field to research the role of neuromodulation through wearable devices to control un-inhibited reflex spasticity of the bladder, bowel and lower limbs. The final aim is to develop a prototype device which provides effective control of these functions without the need for medication.
33 – Activity Based Rehabilitation (ABR) to restore changes in the central nervous system and in trunk muscle function following spinal cord injury: TRUNK CONTROL
Activity Based Rehabilitation (ABR) to restore changes in the central nervous system and in trunk muscle function following spinal cord injury: TRUNK CONTROL
Imperial College London, Award: £103,828, Date of Award: April 2015
It is a challenge for people with incomplete mid-thoracic spinal cord injury (SCI) to keep their upper body stable in order to carry out tasks using the arms, such as dressing, transferring and locomotion using wheelchairs. Poor trunk control consequently has deleterious effects on activities of daily living and independence. Although there is a growing appreciation among clinicians and patients as to the functional association between the trunk and upper limbs, the underlying mechanism and neural pathways involved remain largely unexplored. This project aims to extend our work on healthy subjects to investigate the extent to which upper limb tasks are able to facilitate the neural pathways controlling the trunk muscles after SCI and to reveal the mechanisms involved. We will assess whether such facilitation is retained after exercise-based repetitions of the task and finally, whether this leads to functional improvements in trunk control, such as sitting balance and reaching.
34 – Portable neurofeedback system for treatment of central neuropathic pain following spinal cord injury: BRAIN TRAIN
Portable neurofeedback system for treatment of central neuropathic pain following spinal cord injury: BRAIN TRAIN
University of Glasgow & Queen Elizabeth University Hospital Glasgow, Award: £16,048, Date of Award: October 2015
Spinal Cord Injury (SCI) affects person’s ability to move and feel sensation from the body. SCI is also an indirect cause of a persistent pain, called Central Neuropathic Pain. This pain typically develops several months after the injury. In 30- 40% of SCI patients, severe central neuropathic pain affects their everyday living including sleep and mood. Although central neuropathic pain feels as if it is coming from the paralysed part of the body, it is actually generated in the brain. We developed a system for neurofeedback, brain training using inexpensive wearable wireless electroencephalographic device and a tablet, which costs under £1000. The system uses the same programme as a system that we clinically tested with large and expensive laboratory device. The aim of the project is to assess the potential of a home based patient/caregiver managed therapy for central neuropathic pain using an inexpensive wearable neurorehabilitation system.
35 – Spinal Stimulation ‘sit to stand’ after SCI: STIM2STAND
Spinal Stimulation ‘sit to stand’ after SCI: STIM2STAND
RNOH Stanmore and Neurokinex, Watford, Award: £175,333, Date of Award: October 2016
Spinal Stimulation has been shown to recover voluntary movement, and may promote neuroplasticity, in people with spinal cord injury (SCI). In this study we will explore i) the neurophysiological effects of different patterns of transcutaneous spinal stimulation in healthy subjects and ii) the effects of an 8-week intervention of spinal stimulation sit-to-stand training in people living with SCI. The main goals of the study are: 1) To explore the effects of transcutaneous SS using different stimulation patterns on subjective comfort and central nervous system excitability in healthy subjects. 2) To measure the effects of adding transcutaneous SS to 8 weeks of sit-to-stand training on; i) sit-to-stand performance, ii) bladder function and; iii) health-related quality of life (QoL) in people living with SCI.