Spinal Cord InjuriesNCT04367623
Motor Conditioning to Enhance the Effect of Physical Therapy
A study testing Brain computer interface based therapy in people with Spinal Cord Injuries, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
Spinal Cord Injury (SCI) affects person's ability to move and feel sensation from the body. About half of patients with tetraplegia (high level SCI) have an incomplete injury, i.e. have some sensation and control of muscles preserved and could recover some function of their upper limbs. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Brain computer interface based therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Dec 2020to 1 Sep 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Upper and lower age limit as above
- Incomplete spinal cord injury at level C3-C8 or complete spinal cord injury (C3-C8) with a zone of partially preserved innervation
- Sub-acute patients, likely to remain as inpatient during the period of study
- Normal or corrected to normal vision
Who cannot join
- Self reported neurological conditions prior to the injury that are expected to substantially change the EEG signal (e.g. stroke, epilepsy, brain injury, Parkinson's disease)
- Inability to understand the experimental task
- Brain, brachioplexus or peripheral nerve damage occurring at the time of the spinal cord injury.
- General contraindications for using FES (implanted devices, pregnancy, sensitive skin, automatic dysreflexia)
- Halos (large neck supports surrounding head) preventing EEG recording
- Inability to sit for 1.5 hour due to skin redness or sores
- Infections and general poor health due to injury
- Unable to speak English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring Brain Computer Interface Controlled Functional Electrical Stimulation as a Motor Conditioning Strategy Prior to Physical Practice in People With Subacute Spinal Cord Injury
Spinal Cord Injury (SCI) affects person's ability to move and feel sensation from the body. About half of patients with tetraplegia (high level SCI) have an incomplete injury, i.e. have some sensation and control of muscles preserved and could recover some function of their upper limbs. In this study the researchers would like to increase the effect of physical therapy of the upper limbs by sensory-motor priming. To achieve this they will use Brain Computer Interface (BCI) controlled Functional Electrical Stimulation (FES) immediately prior to the physical therapy of the upper limbs. BCI will be operated by motor attempt (motor priming) which will activate the FES applied to participants' hand muscles to achieve movement (sensory and motor priming). Physical therapy in this study will not replace conventional therapy that participant receive as a part of their standard treatment. There will be two groups: a treatment group (BCI FES with physical therapy) and a control group (physical therapy only), each receiving 20 therapy sessions of matched duration (40-50 min) of their dominant hand. Based on power analysis and results from our study (Osuagwu et al. 2016, J Neural Eng) there will be thirteen participants per group matched by age and the level of injury. Therapy will be applied to dominant hand only, because of the limited time available for experimental studies on participants who are already under active rehabilitation programme. Primary measures will be functional outcomes (range of movement, muscle strength, grip force, independence) while secondary outcomes will be neurological outcomes (EEG activity) and quality of life measures. The outcomes will be compared between the treatment and the control group and between the dominant and the non-dominant hand of each participant.
Read the detailed description
Participants who decide to take part will be assigned to a treatment or a control groups. Both groups will have the same assessments and the same number of therapy sessions. Therapy group will have a training that consist of Brain Computer Interface controlled Functional Electrical Stimulation followed by physical practice of the dominant upper limb while the control group will have physical practice only. One experimental session including will last about 60 min for both groups (including setup and therapy) and participants in each group will receive 20 sessions, about 3 times per week.
- Assesments There will be three assessments: an initial assessment within a week prior to the first therapy session, a final assessment within a week following the last therapy session and a follow up session 3 months after the last therapy session. Assessments will consist of qualitative and quantitative measures. It will comprise of assessments of motor functions, neurological functions and participants feedback on the therapy (questionnaires and. Interviews)
- Therapy There will be 20 therapy sessions for each group 2.1. Therapy Treatment Group This will consist of 30 min of BCI FES followed by 30 min of physical practice of the dominant upper limb. We decided to include only dominant arm/hand from two reasons: Each participant can be their own control to compare the outcome between hands. The other reason is that it is not possible to find more than an hour free time in between of their regular physical therapies and other activities. 2.1.1. BCI FES Participants will be wearing an EEG device (Epoch, Emotiv) and will have several pair of self-adhesive FES electrodes attached to their arms, over muscles that control reaching and grasping. The exact location and number of FES electrodes will be patient specific and will depend on their functional ability.
Each therapy session will start with a 5 min long calibration (to set BCI parameters for that day) followed by training.
During calibration phase participants will watch a computer screen showing a hand squeezing a ball. Participants will imagine doing the same action while their EEG will be recorded. BCI-FES Upon seeing a visual cue (a small cross) on a screen, participants attempt to move their dominant arm and hand to achieve reach and grasp movement towards an object (e.g. a plastic bottle). They repeat this 30 to 40 times in total, targeting 30 successful trials. The number of trials is based on our previous study (Osuagwu et al 2016, J Neural Eng). During each trial, upon the appearance of cue on the screen, the participant has 10 seconds to attempt movement to activate FES. They will practice movements of one hand only so there will be only one type of cue. On a successful attempt, FES will be initiated for 10-15 seconds to complete reach and grasp movement. An anti-gravity support will be used to assist movement, if necessary. This might be mentally demanding for some participants, and they might require breaks in between trials. Thus although BCI FES effectively lasts about 10 min (the same as in our previous study) the whole BCI FES session will take about 30 min. BCI FES will be immediately followed by physical practice. It is not possible to wait for participants regular occupation therapy because of a relatively short duration of the motor priming effect (from the literature it is 10-30 min).
After 1st, 5th, 10th , 15th and 20th session participants will fill out NASA task load index questionnaire, which takes about 5 min. This measures their workload. 2.1.2. Physical practice Immediately after BCI FES, participant will have physical therapy for 30 min. The objects and devices typically used in occupational therapy, putty, pegboards, nut-bolt-boards, rings, etc will be used for reaching and grasping tasks. These tasks may change over time depending on the capability of participant. FES will not be used in this phase 2.2. Therapy Control Group Control group will receive 40 min of physical practice only, that will be similar to the physical practice in the treatment group. Total duration is based on the total duration of BCI FES (10 min) and physical practice (30 min) in the treatment group.
- Conditions
- Spinal Cord Injuries
- Being tested
- Brain computer interface based therapy
- 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.
Brain computer interface based therapyOther
Participants who decide to take part will be assigned to a treatment or a control group. Both groups will have the same assessments and the same number of therapy sessions. Therapy group will have a training that consists of Brain Computer Interface controlled Functional Electrical Stimulation followed by a physical practice of the dominant upper limb, while the control group will have a physical practice only. One experimental session will last about 60 min for both groups (including setup and therapy) and participants in each group will receive 20 sessions, about 3 times per week. The expected time needed for completion of 20 sessions is 7 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Patients receiving conventional hand therapy, time matched to the duration of total intervention in the Active group Receives: Other: Brain computer interface based therapy |
| Active | Active comparator | Patients receiving BCI FES prior to the conventional therapy Receives: Other: Brain computer interface based therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Spinal Cord Independence measure (range 0 to 100, max 100)
Spinal Cord Independence measure Questionnaire regarding independence in activities of daily living
Measured: two months: baseline and upon completion of the therapy, typically 9 weeks
Change in the hand range of motion (range 0 to 90 degress, max 90 degress)
Change in the range of motion measured by goniometer (o degrees)
Measured: two months: baseline and upon completion of thetherapy, typically 9 weeks
Changes in the Manual muscle test (range 0 to 5, max 5)
Change of strength of individual hand and arm muscles
Measured: two months: baseline and upon completion of the therapy, typically 9 weeks
Change in grip strength (range 0 to 80 N, max 80 N)
Change in grip strength (N)
Measured: two months: baseline and upon completion of the therapy, typically 9 weeks
Secondary outcomes (5)
Changes in Multichannel brain activity measured by electroencephalography (EEG) during attempted or imagined movements
Event related synchronisation/desynchronsation (%) (-200% to 100%, max 100%)
Measured: two months: baseline and after completion of the therapy, typically 9 weeks
Changes in baseline multichannel electroencephalogaphy (EEG) measurement
Measurement of brain activity at rest (%) (0-100%, max 100%)
Measured: two months: baseline and upon completion of the therapy, typically 9 weeks
Changes NASA (National Aeronautics and Space Administration) task load index
Questionnaire measuring mental work load during therapy (0 very low to 10 very high)
Measured: after 1st, 10st and 20th therapy session (typically 0, 3 and 9 weeks -there is a washout peiord between first and last 10 sesions)
Quebec User Evaluation of Satisfaction with Assistive Technology
questionnaire (two parts. Part 1 Device range 0 to 40, max 40; Part 2 Services, range 0 to 20, max 20)
Measured: Upon completion of the therapy, typically 9 weeks
Patient feedback, satisfaction with therapy
semistructured interview (no units)
Measured: Upon completion of the therapy, typically 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start9 Dec 2020
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Why it stopped: Delays in approval process, COVID restrictions, staffing shortages
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 InjuriesStudies 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
- None (open label)
- Enrolment
- 10 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
- NCT04367623
- Sponsor's protocol ID
- GN19NE396
- Status last verified
- Dec 2022
- First submitted
- 13 Feb 2020
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Brain Computer Interface Controlled Functional Electrical Stimulation as a Motor Conditioning Strategy Prior to Physical Practice in People With Subacute Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04367623
- Acronym / sponsor ID
- GN19NE396
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Delays in approval process, COVID restrictions, staffing shortages
- Enrolment
- 10 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 29 Apr 2020 (actual)
- 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.
Spinal Cord Injury (SCI) affects person's ability to move and feel sensation from the body. About half of patients with tetraplegia (high level SCI) have an incomplete injury, i.e. have some sensation and control of muscles preserved and could recover some function of their upper limbs. In this study the researchers would like to increase the effect of physical therapy of the upper limbs by sensory-motor priming. To achieve this they will use Brain Computer Interface (BCI) controlled Functional Electrical Stimulation (FES) immediately prior to the physical therapy of the upper limbs. BCI will be operated by motor attempt (motor priming) which will activate the FES applied to participants' hand muscles to achieve movement (sensory and motor priming). Physical therapy in this study will not replace conventional therapy that participant receive as a part of their standard treatment. There will be two groups: a treatment group (BCI FES with physical therapy) and a control group (physical therapy only), each receiving 20 therapy sessions of matched duration (40-50 min) of their dominant hand. Based on power analysis and results from our study (Osuagwu et al. 2016, J Neural Eng) there will be thirteen participants per group matched by age and the level of injury. Therapy will be applied to dominant hand only, because of the limited time available for experimental studies on participants who are already under active rehabilitation programme. Primary measures will be functional outcomes (range of movement, muscle strength, grip force, independence) while secondary outcomes will be neurological outcomes (EEG activity) and quality of life measures. The outcomes will be compared between the treatment and the control group and between the dominant and the non-dominant hand of each participant.
Detailed description
Participants who decide to take part will be assigned to a treatment or a control groups. Both groups will have the same assessments and the same number of therapy sessions. Therapy group will have a training that consist of Brain Computer Interface controlled Functional Electrical Stimulation followed by physical practice of the dominant upper limb while the control group will have physical practice only. One experimental session including will last about 60 min for both groups (including setup and therapy) and participants in each group will receive 20 sessions, about 3 times per week.
- Assesments There will be three assessments: an initial assessment within a week prior to the first therapy session, a final assessment within a week following the last therapy session and a follow up session 3 months after the last therapy session. Assessments will consist of qualitative and quantitative measures. It will comprise of assessments of motor functions, neurological functions and participants feedback on the therapy (questionnaires and. Interviews)
- Therapy There will be 20 therapy sessions for each group 2.1. Therapy Treatment Group This will consist of 30 min of BCI FES followed by 30 min of physical practice of the dominant upper limb. We decided to include only dominant arm/hand from two reasons: Each participant can be their own control to compare the outcome between hands. The other reason is that it is not possible to find more than an hour free time in between of their regular physical therapies and other activities. 2.1.1. BCI FES Participants will be wearing an EEG device (Epoch, Emotiv) and will have several pair of self-adhesive FES electrodes attached to their arms, over muscles that control reaching and grasping. The exact location and number of FES electrodes will be patient specific and will depend on their functional ability.
Each therapy session will start with a 5 min long calibration (to set BCI parameters for that day) followed by training.
During calibration phase participants will watch a computer screen showing a hand squeezing a ball. Participants will imagine doing the same action while their EEG will be recorded. BCI-FES Upon seeing a visual cue (a small cross) on a screen, participants attempt to move their dominant arm and hand to achieve reach and grasp movement towards an object (e.g. a plastic bottle). They repeat this 30 to 40 times in total, targeting 30 successful trials. The number of trials is based on our previous study (Osuagwu et al 2016, J Neural Eng). During each trial, upon the appearance of cue on the screen, the participant has 10 seconds to attempt movement to activate FES. They will practice movements of one hand only so there will be only one type of cue. On a successful attempt, FES will be initiated for 10-15 seconds to complete reach and grasp movement. An anti-gravity support will be used to assist movement, if necessary. This might be mentally demanding for some participants, and they might require breaks in between trials. Thus although BCI FES effectively lasts about 10 min (the same as in our previous study) the whole BCI FES session will take about 30 min. BCI FES will be immediately followed by physical practice. It is not possible to wait for participants regular occupation therapy because of a relatively short duration of the motor priming effect (from the literature it is 10-30 min).
After 1st, 5th, 10th , 15th and 20th session participants will fill out NASA task load index questionnaire, which takes about 5 min. This measures their workload. 2.1.2. Physical practice Immediately after BCI FES, participant will have physical therapy for 30 min. The objects and devices typically used in occupational therapy, putty, pegboards, nut-bolt-boards, rings, etc will be used for reaching and grasping tasks. These tasks may change over time depending on the capability of participant. FES will not be used in this phase 2.2. Therapy Control Group Control group will receive 40 min of physical practice only, that will be similar to the physical practice in the treatment group. Total duration is based on the total duration of BCI FES (10 min) and physical practice (30 min) in the treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Brain computer interface based therapyPatients receiving conventional hand therapy, time matched to the duration of total intervention in the Active group |
| Active | Active comparator | Other: Brain computer interface based therapyPatients receiving BCI FES prior to the conventional therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Upper and lower age limit as above
- Incomplete spinal cord injury at level C3-C8 or complete spinal cord injury (C3-C8) with a zone of partially preserved innervation
- Sub-acute patients, likely to remain as inpatient during the period of study
- Normal or corrected to normal vision
Key exclusion criteria (8 listed)
- Self reported neurological conditions prior to the injury that are expected to substantially change the EEG signal (e.g. stroke, epilepsy, brain injury, Parkinson's disease)
- Inability to understand the experimental task
- Brain, brachioplexus or peripheral nerve damage occurring at the time of the spinal cord injury.
- General contraindications for using FES (implanted devices, pregnancy, sensitive skin, automatic dysreflexia)
- Halos (large neck supports surrounding head) preventing EEG recording
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 |
|---|---|---|
| Brain computer interface based therapyParticipants who decide to take part will be assigned to a treatment or a control group. Both groups will have the same assessments and the same number of therapy sessions. Therapy group will have a training that consists of Brain Computer Interface controlled Functional Electrical Stimulation followed by a physical practice of the dominant upper limb, while the control group will have a physical practice only. One experimental session will last about 60 min for both groups (including setup and therapy) and participants in each group will receive 20 sessions, about 3 times per week. The expected time needed for completion of 20 sessions is 7 weeks | Other | Active, Control |
Primary outcome
Changes in Spinal Cord Independence measure (range 0 to 100, max 100)
Time frame: two months: baseline and upon completion of the therapy, typically 9 weeks
Spinal Cord Independence measure Questionnaire regarding independence in activities of daily living
Change in the hand range of motion (range 0 to 90 degress, max 90 degress)
Time frame: two months: baseline and upon completion of thetherapy, typically 9 weeks
Change in the range of motion measured by goniometer (o degrees)
Changes in the Manual muscle test (range 0 to 5, max 5)
Time frame: two months: baseline and upon completion of the therapy, typically 9 weeks
Change of strength of individual hand and arm muscles
Change in grip strength (range 0 to 80 N, max 80 N)
Time frame: two months: baseline and upon completion of the therapy, typically 9 weeks
Change in grip strength (N)
5 secondary outcomes
Changes in Multichannel brain activity measured by electroencephalography (EEG) during attempted or imagined movements
Time frame: two months: baseline and after completion of the therapy, typically 9 weeks
Changes in baseline multichannel electroencephalogaphy (EEG) measurement
Time frame: two months: baseline and upon completion of the therapy, typically 9 weeks
Changes NASA (National Aeronautics and Space Administration) task load index
Time frame: after 1st, 10st and 20th therapy session (typically 0, 3 and 9 weeks -there is a washout peiord between first and last 10 sesions)
Quebec User Evaluation of Satisfaction with Assistive Technology
Time frame: Upon completion of the therapy, typically 9 weeks
Patient feedback, satisfaction with therapy
Time frame: Upon completion of the therapy, typically 9 weeks
Results and safety
The study was stopped early (reason given: Delays in approval process, COVID restrictions, staffing shortages). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Background: 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.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
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 Brain computer interface based therapy in people with Spinal Cord Injuries, 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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 9 Dec 2022. 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 was stopped early (reason given: Delays in approval process, COVID restrictions, staffing shortages). Results are not available in the source record.
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?
Changes in Spinal Cord Independence measure (range 0 to 100, max 100) (time frame: two months: baseline and upon completion of the therapy, typically 9 weeks). The study lists 4 primary outcomes in all. 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 NCT04367623, 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 9 Dec 2022.