Clinical trial NCT03257982: Patient Self-managed BCI-FES
Official title: A Feasibility Study of Patient Self-Managed Brain-computer Interface Functional Electrical Stimulation (BCI-FES) Hand Therapy for Spinal Cord Injured Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Brain-computer interface
Functional electrical stimulation
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: University of Glasgow
First posted: 2017-08-22
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Successful training for operation of BCI-FES system
timeFrame: 2 months
Secondary outcomes:
measure: System reliability
timeFrame: 2 months
measure: Time taken to use system
timeFrame: 2 months
measure: NASA task load index
timeFrame: 2 months
measure: Psychological Effect of Assistive Devices
timeFrame: 2 months
measure: Quebec User Evaluation of Satisfaction with Assistive Technology
timeFrame: 2 months
measure: Grip strength
timeFrame: Baseline and 2 months
measure: Hand range of motion
timeFrame: Baseline and 2 months
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth National Spinal Injuries Unit
Study officials:
affiliation: University of Glasgow
name: Aleksandra Vuckovic, BEng MSc PhD
role: STUDY_DIRECTOR
References:
citation: 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.