Patient Self-managed BCI-FES

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03257982
• Other study ID #: GN17NE402
• Status: Completed
• Phase: N/A
• Start date: January 25, 2018
• Est. completion date: March 14, 2019

Study information

• Verified date: January 2021
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 14, 2019
• Est. primary completion date: March 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Procedure:
• BCI-FES hand therapy
BCI-FES rehabilitation therapy of the upper limb

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth National Spinal Injuries Unit	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful training for operation of BCI-FES system	Number of times patients/caregivers successfully operate BCI-FES system within 30 min	2 months
Secondary	System reliability	Number of times patients manage to activate the BCI-FES system	2 months
Secondary	Time taken to use system	Average time required to accomplish BCI-FES therapy (excluding setup time)	2 months
Secondary	NASA task load index	Score from National Aeronautics and Space Administration (NASA) Task Load Index questionnaire	2 months
Secondary	Psychological Effect of Assistive Devices	Score of Psychological Effect of Assistive Devices questionnaire	2 months
Secondary	Quebec User Evaluation of Satisfaction with Assistive Technology	Score of Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire	2 months
Secondary	Grip strength	Change in grip strength	Baseline and 2 months
Secondary	Hand range of motion	Change in hand range of motion	Baseline and 2 months