Patient Self-managed BCI-FES

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Feasibility Study of Patient Self-Managed Brain-computer Interface Functional Electrical Stimulation (BCI-FES) Hand Therapy for Spinal Cord Injured Patients

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Procedure: BCI-FES hand therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BCI-FES hand therapy<br>BCI-FES hand therapy sessions (set up and use of system) | Procedure: BCI-FES hand therapy<br>* BCI-FES rehabilitation therapy of the upper limb<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful training for operation of BCI-FES system | 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 | Number of times patients manage to activate the BCI-FES system | 2 months | 
| Time taken to use system | Average time required to accomplish BCI-FES therapy (excluding setup time) | 2 months | 
| NASA task load index | Score from National Aeronautics and Space Administration (NASA) Task Load Index questionnaire | 2 months | 
| Psychological Effect of Assistive Devices | Score of Psychological Effect of Assistive Devices questionnaire | 2 months | 
| Quebec User Evaluation of Satisfaction with Assistive Technology | Score of Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire | 2 months | 
| Grip strength | Change in grip strength | Baseline and 2 months | 
| Hand range of motion | Change in hand range of motion | Baseline and 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain-computer interface, Functional electrical stimulation