- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03257982
Patient Self-managed BCI-FES
A Feasibility Study of Patient Self-Managed Brain-computer Interface Functional Electrical Stimulation (BCI-FES) Hand Therapy for Spinal Cord Injured Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Glasgow, United Kingdom
- Queen Elizabeth National Spinal Injuries Unit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
- 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
Exclusion Criteria:
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)
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BCI-FES hand therapy
BCI-FES hand therapy sessions (set up and use of system)
|
BCI-FES rehabilitation therapy of the upper limb
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
System reliability
Time Frame: 2 months
|
Number of times patients manage to activate the BCI-FES system
|
2 months
|
Time taken to use system
Time Frame: 2 months
|
Average time required to accomplish BCI-FES therapy (excluding setup time)
|
2 months
|
NASA task load index
Time Frame: 2 months
|
Score from National Aeronautics and Space Administration (NASA) Task Load Index questionnaire
|
2 months
|
Psychological Effect of Assistive Devices
Time Frame: 2 months
|
Score of Psychological Effect of Assistive Devices questionnaire
|
2 months
|
Quebec User Evaluation of Satisfaction with Assistive Technology
Time Frame: 2 months
|
Score of Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire
|
2 months
|
Grip strength
Time Frame: Baseline and 2 months
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Change in grip strength
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Baseline and 2 months
|
Hand range of motion
Time Frame: Baseline and 2 months
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Change in hand range of motion
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Baseline and 2 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Aleksandra Vuckovic, BEng MSc PhD, University of Glasgow
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GN17NE402
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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