Spinal Cord InjuriesNCT03257982
Patient Self-managed BCI-FES
A study testing BCI-FES hand therapy in people with Spinal Cord Injuries, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
This study aims to assess the feasibility of therapist-caregiver-patient training to use BCI and FES technology with a view to the inexpensive equipment eventually being used for home use by tetraplegic patients as a continuing rehabilitation method for sub-acute patients discharged from hospital. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- BCI-FES hand therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Jan 2018to 14 Mar 2019
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients
- being within a year post-injury
- has a caregiver willing to commit their time to the study
- normal or corrected to normal vision
- no history of brain disease or injury
- incomplete injury at level C2 to C7
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- minimum computer literacy
- understands spoken and written English
- Occupational therapists
- already has experience in providing occupational therapy to spinal cord injured people
- familiar with using FES on patients
- Caregivers
- able and willing to commit time to the study
- minimum computer literacy
- possess mobile phone with a camera or are allowed to use patient's mobile phone with a camera for taking photos of the experimental setup (to remind themselves)
- understands spoken and written English
Who cannot join
- Patients
- presence of neurological problem which may distort brain signal recording (e.g. epilepsy, Parkinson's disease, multiple sclerosis)
- presence of cognitive impairments which would prevent patients or caregivers from understanding the task
- inability to sit for 2 hours
- general poor health due to secondary consequences of injury
- any condition that would be contraindicative of using FES (pacemakers, sensitive skin/sores over areas where electrodes should be applied, pregnancy)
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- Occupational therapists
- unable to commit sufficient time to the study
- cannot learn to setup BCI-FES within 30 min within 4 hourly training sessions
- Caregivers
- cannot be present for all five therapy sessions
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Elizabeth National Spinal Injuries Unit
Glasgow
About this study
Official title: A Feasibility Study of Patient Self-Managed Brain-computer Interface Functional Electrical Stimulation (BCI-FES) Hand Therapy for Spinal Cord Injured Patients
This study aims to assess the feasibility of therapist-caregiver-patient training to use BCI and FES technology with a view to the inexpensive equipment eventually being used for home use by tetraplegic patients as a continuing rehabilitation method for sub-acute patients discharged from hospital.
Read the detailed description
Spinal Cord Injury (SCI) affects a person's ability to move and feel sensation in the body. People with injury around the neck, suffer from tetraplegia, which affects function of both upper and lower limbs. Although these patients often have a caregiver, their main priority is to regain some upper limb function to increase independence. About half of patients with tetraplegia have an incomplete injury, i.e. have some sensation and control of muscles preserved. Natural recovery takes about a year and is typically accompanied by intense physical therapy while patients are in a hospital. Patients spend on average 4 months in hospital and, once they go home, there are very limited options for further therapy, in particular those living in rural areas.
This study will test the feasibility of patient and caregiver self-managed hand therapy based on the combination of brain computer interface (BCI) and functional electrical stimulation (FES). BCI is a system which consists of an electroencephalographic device (EEG), a computer and software that can analyse EEG while it is being recorded. To ensure that the knowledge stays within hospital, occupational therapists will first be trained who will then train patients and caregivers. The BCI-FES therapy is based on a previous clinical study with hospitalised patients, in which a researcher administered the therapy. In this study, a portable BCI-FES system will be used with an inexpensive consumer BCI, which is designed for non-professionals. The primary objective is to assess whether it is feasible for caregivers and patients to learn to operate the portable BCI-FES system on their own within 5 training sessions. The secondary objectives are to collect feedback from patients and therapists of their views via semi-structured interviews and questionnaires; to assess how stable the system parameters (EEG parameters, electrode location, FES stimulation parameters)are over time; to assess whether there is any functional and neurological recovery.
- Conditions
- Spinal Cord Injuries
- Being tested
- BCI-FES hand therapy
- Keywords
- Brain-computer interface, Functional electrical 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-FES hand therapyProcedure or surgery
BCI-FES rehabilitation therapy of the upper limb
| Study group | Role | What they receive |
|---|---|---|
| BCI-FES hand therapy | Experimental | BCI-FES hand therapy sessions (set up and use of system) Receives: Procedure: BCI-FES hand therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful training for operation of BCI-FES system
Number of times patients/caregivers successfully operate BCI-FES system within 30 min
Measured: 2 months
Secondary outcomes (7)
System reliability
Number of times patients manage to activate the BCI-FES system
Measured: 2 months
Time taken to use system
Average time required to accomplish BCI-FES therapy (excluding setup time)
Measured: 2 months
NASA task load index
Score from National Aeronautics and Space Administration (NASA) Task Load Index questionnaire
Measured: 2 months
Psychological Effect of Assistive Devices
Score of Psychological Effect of Assistive Devices questionnaire
Measured: 2 months
Quebec User Evaluation of Satisfaction with Assistive Technology
Score of Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire
Measured: 2 months
Grip strength
Change in grip strength
Measured: Baseline and 2 months
Hand range of motion
Change in hand range of motion
Measured: Baseline and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start25 Jan 2018
- Primary completion14 Mar 2019
- Study completion14 Mar 2019
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 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, BEng MSc PhD, Study director, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257982
- Sponsor's protocol ID
- GN17NE402
- Status last verified
- Jan 2021
- First submitted
- 16 Aug 2017
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zulauf-Czaja A, Al-Taleb MKH, Purcell M, Petric-Gray N, Cloughley J, Vuckovic A. On the way home: a BCI-FES hand therapy self-managed by sub-acute SCI participants and their caregivers: a usability study. J Neuroeng Rehabil. 2021 Feb 25;18(1):44. doi: 10.1186/s12984-021-00838-y.
PubMed 33632262
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Patient Self-Managed Brain-computer Interface Functional Electrical Stimulation (BCI-FES) Hand Therapy for Spinal Cord Injured Patients
- ClinicalTrials.gov ID
- NCT03257982
- Acronym / sponsor ID
- GN17NE402
- Conditions
- Spinal Cord Injuries
- Keywords
- Brain-computer interface, Functional electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 14 Mar 2019 (actual)
- Study completion
- 14 Mar 2019 (actual)
- First posted
- 22 Aug 2017 (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.
This study aims to assess the feasibility of therapist-caregiver-patient training to use BCI and FES technology with a view to the inexpensive equipment eventually being used for home use by tetraplegic patients as a continuing rehabilitation method for sub-acute patients discharged from hospital.
Detailed description
Spinal Cord Injury (SCI) affects a person's ability to move and feel sensation in the body. People with injury around the neck, suffer from tetraplegia, which affects function of both upper and lower limbs. Although these patients often have a caregiver, their main priority is to regain some upper limb function to increase independence. About half of patients with tetraplegia have an incomplete injury, i.e. have some sensation and control of muscles preserved. Natural recovery takes about a year and is typically accompanied by intense physical therapy while patients are in a hospital. Patients spend on average 4 months in hospital and, once they go home, there are very limited options for further therapy, in particular those living in rural areas.
This study will test the feasibility of patient and caregiver self-managed hand therapy based on the combination of brain computer interface (BCI) and functional electrical stimulation (FES). BCI is a system which consists of an electroencephalographic device (EEG), a computer and software that can analyse EEG while it is being recorded. To ensure that the knowledge stays within hospital, occupational therapists will first be trained who will then train patients and caregivers. The BCI-FES therapy is based on a previous clinical study with hospitalised patients, in which a researcher administered the therapy. In this study, a portable BCI-FES system will be used with an inexpensive consumer BCI, which is designed for non-professionals. The primary objective is to assess whether it is feasible for caregivers and patients to learn to operate the portable BCI-FES system on their own within 5 training sessions. The secondary objectives are to collect feedback from patients and therapists of their views via semi-structured interviews and questionnaires; to assess how stable the system parameters (EEG parameters, electrode location, FES stimulation parameters)are over time; to assess whether there is any functional and neurological recovery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCI-FES hand therapy | Experimental | Procedure: BCI-FES hand therapyBCI-FES hand therapy sessions (set up and use of system) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients
- being within a year post-injury
- has a caregiver willing to commit their time to the study
- normal or corrected to normal vision
- no history of brain disease or injury
Key exclusion criteria (11 listed)
- Patients
- presence of neurological problem which may distort brain signal recording (e.g. epilepsy, Parkinson's disease, multiple sclerosis)
- presence of cognitive impairments which would prevent patients or caregivers from understanding the task
- inability to sit for 2 hours
- general poor health due to secondary consequences of injury
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-FES hand therapyBCI-FES rehabilitation therapy of the upper limb | Procedure or surgery | BCI-FES hand therapy |
Primary outcome
Successful training for operation of BCI-FES system
Time frame: 2 months
Number of times patients/caregivers successfully operate BCI-FES system within 30 min
7 secondary outcomes
System reliability
Time frame: 2 months
Time taken to use system
Time frame: 2 months
NASA task load index
Time frame: 2 months
Psychological Effect of Assistive Devices
Time frame: 2 months
Quebec User Evaluation of Satisfaction with Assistive Technology
Time frame: 2 months
Grip strength
Time frame: Baseline and 2 months
Hand range of motion
Time frame: Baseline and 2 months
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 Jan 2021.
- Derived from this study: PubMed 33632262Zulauf-Czaja A, Al-Taleb MKH, Purcell M, Petric-Gray N, Cloughley J, Vuckovic A. On the way home: a BCI-FES hand therapy self-managed by sub-acute SCI participants and their caregivers: a usability study. J Neuroeng Rehabil. 2021 Feb 25;18(1):44. doi: 10.1186/s12984-021-00838-y.
- Individual participant dataSharing planned: No
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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, BEng MSc PhD study director
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 hand 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 16 inclusion and 11 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 Jan 2021. 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?
Successful training for operation of BCI-FES system (time frame: 2 months). 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 NCT03257982, 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 Jan 2021.