Spinal Cord InjuryNCT01852279
BCI and FES for Hand Therapy in Spinal Cord Injury
A study testing BCI-FES and Passive muscle stimulation in people with Spinal Cord Injury, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
This study will assess whether functional recovery of the hand muscles in patients with spinal cord injury is enhanced when electrical stimulation of the muscles is delivered actively by means of using the electroencephalography wave patterns arising from the patient imagining moving their hand to operate the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- BCI-FES and Passive muscle stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 May 2013to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- incomplete (ASIA B, C) tetraplegia with injury at level C4-C8
- aged between 18 and 70 years old
- a candidate suitable for the conventional therapy
Who cannot join
- Patients must not have presence of any neurological problem that might distort recording standard brain signal during motor imagination (example: brain damage, epilepsy, Parkinson disease and multiple sclerosis)
- Patients must not have cognitive impairments (hearing, vision and general inability to understand instructions)
- Patients must not suffer from recurring pressure sore which prevent patient from sitting for at least an hour
- Patients must not suffer from excessive spasm that would increase with electrical stimulation.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Elizabeth National Spinal Injuries Unit
Glasgow
About this study
Official title: Brain Computer Interface Control of Functional Electrical Stimulation for a Hand Therapy in Tetraplegic Patients
This study will assess whether functional recovery of the hand muscles in patients with spinal cord injury is enhanced when electrical stimulation of the muscles is delivered actively by means of using the electroencephalography wave patterns arising from the patient imagining moving their hand to operate the stimulator. A control group will obtain the electrical stimulation treatment passively by a therapist operating the machine.
Read the detailed description
Injuries of the higher levels of the spinal cord, called tetraplegia, result in a complete or partial paralysis of both legs and arms, making the person dependent on their caregivers for elementary activities of daily living (ADL) such as drinking and feeding. About 60% of tetraplegics have an incomplete injury and can partially recover their movement and sensation. The success of a recovery greatly depends on the therapy within the first year after the injury. Functional electrical stimulation (FES) is a relatively novel therapy of the hand. In FES therapy electrodes are attached on the surface the patients's forearms and electrical current is delivered through them. A disadvantage of the current FES therapy is that a therapist has to switch the stimulator on and off because patients cannot use either of their hands. In our previous pilot study performed on two acute tetraplegic patients we tested feasibility of using brain-computer interface (BCI) to control FES on patient's will. BCI is based on recording the patient's brain activity. BCI can detect the patient's intention to move the hand even if they are not able to physically move it. Using BCI, patients control the FES by thinking to move their hand.
A BCI-FES therapy will provide a simultaneous training of neural pathways from the brain to the hand muscle (motor imagination/attempt) and from the muscle to the brain (electrical stimulation of muscles). This form of therapy could promote faster and more complete recovery
In this controlled study we aim to provide a BCI-FES therapy to both chronic and subacute tetraplegic patients over a period of 20 sessions and to access the functional and neurological outcome of the therapy. Five chronic patients (more than a year after the injury) will participate in a cross-over study as we do not expect that they will recover spontaneously without BCI-FES. Subacute patients will be receiving both a conventional therapy and BCI-FES so recovery can be caused by either of these two therapies. Therefore it is necessary to have a treatment and a control group. Each group will have 10 patients, age and injury matched. Both groups will receive the same amount of electrical stimulation but only the treatment group will voluntarily control the electrical stimulator using BCI. A control group will receive passive electrical stimulation of the same hand muscles but without using BCI.
- Conditions
- Spinal Cord Injury
- Being tested
- BCI-FES, Passive muscle stimulation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCI-FESDevice
Brain computer Interface delivered Function Electrical Stimulation
Passive muscle stimulationDevice
Functional Electrical stimulation delivered by therapist
| Study group | Role | What they receive |
|---|---|---|
| Active muscle stimulation | Experimental | Muscle stimulation delivered by Brain Computer Interface Receives: Device: BCI-FES |
| Passive muscle stimulation | Active comparator | FES will be delivered by therapist Receives: Device: Passive muscle stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength as measured by the Oxford manual test
Measured: Between initial and final assessment after up to 8 weeks of treatment
Secondary outcomes (7)
Changes in patients EEG before and after each treatment session
Measures will be taken at the beginning and end of each of the 20 treatment sessions
Measured: between beginning and end of each one hour treatment session
Difference in EEG between the treatment and the control group
Measured: Between initial and final assessment after up to 8 weeks of treatment
Difference in Somatosensory evoked potential between the treatment and control group
Measured: Between initial and final assessment after up to 8 weeks of treatment
Difference in somatosensory evoked potential before and after a treatment session
Measured: Between initial and final assessment after up to 8 weeks of treatment
Patient's experience of using BCI-FES
A questionnaire will collect information
Measured: Between initial and final assessment after up to 8 weeks of treatment
Quadriplegia index of function
Measured: Between initial and final assessment after up to 8 weeks of treatment
Range of movement of wrists and fingers
Measured: Between initial and final assessment after up to 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study start8 May 2013
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Aleksandra Vuckovic, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852279
- Sponsor's protocol ID
- GN12NE574
- Status last verified
- Dec 2020
- First submitted
- 30 Apr 2013
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Osuagwu BC, Wallace L, Fraser M, Vuckovic A. Rehabilitation of hand in subacute tetraplegic patients based on brain computer interface and functional electrical stimulation: a randomised pilot study. J Neural Eng. 2016 Dec;13(6):065002. doi: 10.1088/1741-2560/13/6/065002. Epub 2016 Oct 14.
PubMed 27739405
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Computer Interface Control of Functional Electrical Stimulation for a Hand Therapy in Tetraplegic Patients
- ClinicalTrials.gov ID
- NCT01852279
- Acronym / sponsor ID
- GN12NE574
- Conditions
- Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 8 May 2013 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 13 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess whether functional recovery of the hand muscles in patients with spinal cord injury is enhanced when electrical stimulation of the muscles is delivered actively by means of using the electroencephalography wave patterns arising from the patient imagining moving their hand to operate the stimulator. A control group will obtain the electrical stimulation treatment passively by a therapist operating the machine.
Detailed description
Injuries of the higher levels of the spinal cord, called tetraplegia, result in a complete or partial paralysis of both legs and arms, making the person dependent on their caregivers for elementary activities of daily living (ADL) such as drinking and feeding. About 60% of tetraplegics have an incomplete injury and can partially recover their movement and sensation. The success of a recovery greatly depends on the therapy within the first year after the injury. Functional electrical stimulation (FES) is a relatively novel therapy of the hand. In FES therapy electrodes are attached on the surface the patients's forearms and electrical current is delivered through them. A disadvantage of the current FES therapy is that a therapist has to switch the stimulator on and off because patients cannot use either of their hands. In our previous pilot study performed on two acute tetraplegic patients we tested feasibility of using brain-computer interface (BCI) to control FES on patient's will. BCI is based on recording the patient's brain activity. BCI can detect the patient's intention to move the hand even if they are not able to physically move it. Using BCI, patients control the FES by thinking to move their hand.
A BCI-FES therapy will provide a simultaneous training of neural pathways from the brain to the hand muscle (motor imagination/attempt) and from the muscle to the brain (electrical stimulation of muscles). This form of therapy could promote faster and more complete recovery
In this controlled study we aim to provide a BCI-FES therapy to both chronic and subacute tetraplegic patients over a period of 20 sessions and to access the functional and neurological outcome of the therapy. Five chronic patients (more than a year after the injury) will participate in a cross-over study as we do not expect that they will recover spontaneously without BCI-FES. Subacute patients will be receiving both a conventional therapy and BCI-FES so recovery can be caused by either of these two therapies. Therefore it is necessary to have a treatment and a control group. Each group will have 10 patients, age and injury matched. Both groups will receive the same amount of electrical stimulation but only the treatment group will voluntarily control the electrical stimulator using BCI. A control group will receive passive electrical stimulation of the same hand muscles but without using BCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active muscle stimulation | Experimental | Device: BCI-FESMuscle stimulation delivered by Brain Computer Interface |
| Passive muscle stimulation | Active comparator | Device: Passive muscle stimulationFES will be delivered by therapist |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- incomplete (ASIA B, C) tetraplegia with injury at level C4-C8
- aged between 18 and 70 years old
- a candidate suitable for the conventional therapy
Key exclusion criteria (4 listed)
- Patients must not have presence of any neurological problem that might distort recording standard brain signal during motor imagination (example: brain damage, epilepsy, Parkinson disease and multiple sclerosis)
- Patients must not have cognitive impairments (hearing, vision and general inability to understand instructions)
- Patients must not suffer from recurring pressure sore which prevent patient from sitting for at least an hour
- Patients must not suffer from excessive spasm that would increase with electrical stimulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCI-FESBrain computer Interface delivered Function Electrical Stimulation | Device | Active muscle stimulation |
| Passive muscle stimulationFunctional Electrical stimulation delivered by therapist | Device | Passive muscle stimulation |
Primary outcome
Muscle strength as measured by the Oxford manual test
Time frame: Between initial and final assessment after up to 8 weeks of treatment
7 secondary outcomes
Changes in patients EEG before and after each treatment session
Time frame: between beginning and end of each one hour treatment session
Difference in EEG between the treatment and the control group
Time frame: Between initial and final assessment after up to 8 weeks of treatment
Difference in Somatosensory evoked potential between the treatment and control group
Time frame: Between initial and final assessment after up to 8 weeks of treatment
Difference in somatosensory evoked potential before and after a treatment session
Time frame: Between initial and final assessment after up to 8 weeks of treatment
Patient's experience of using BCI-FES
Time frame: Between initial and final assessment after up to 8 weeks of treatment
Quadriplegia index of function
Time frame: Between initial and final assessment after up to 8 weeks of treatment
Range of movement of wrists and fingers
Time frame: Between initial and final assessment after up to 8 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Derived from this study: PubMed 27739405Osuagwu BC, Wallace L, Fraser M, Vuckovic A. Rehabilitation of hand in subacute tetraplegic patients based on brain computer interface and functional electrical stimulation: a randomised pilot study. J Neural Eng. 2016 Dec;13(6):065002. doi: 10.1088/1741-2560/13/6/065002. Epub 2016 Oct 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleksandra Vuckovic, PhD principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCI-FES and Passive muscle stimulation in people with Spinal Cord Injury, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength as measured by the Oxford manual test (time frame: Between initial and final assessment after up to 8 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01852279, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.