BCI and FES for Hand Therapy in Spinal Cord Injury

Brain Computer Interface Control of Functional Electrical Stimulation for a Hand Therapy in Tetraplegic Patients

This study will assess whether functional recovery of the hand muscles in patients with spinal cord injury is enhanced when electrical stimulation of the muscles is delivered actively by means of using the electroencephalography wave patterns arising from the patient imagining moving their hand to operate the stimulator. A control group will obtain the electrical stimulation treatment passively by a therapist operating the machine.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Device: BCI-FES; Device: Passive muscle stimulation

Detailed Description

Injuries of the higher levels of the spinal cord, called tetraplegia, result in a complete or partial paralysis of both legs and arms, making the person dependent on their caregivers for elementary activities of daily living (ADL) such as drinking and feeding. About 60% of tetraplegics have an incomplete injury and can partially recover their movement and sensation. The success of a recovery greatly depends on the therapy within the first year after the injury. Functional electrical stimulation (FES) is a relatively novel therapy of the hand. In FES therapy electrodes are attached on the surface the patients's forearms and electrical current is delivered through them. A disadvantage of the current FES therapy is that a therapist has to switch the stimulator on and off because patients cannot use either of their hands. In our previous pilot study performed on two acute tetraplegic patients we tested feasibility of using brain-computer interface (BCI) to control FES on patient's will. BCI is based on recording the patient's brain activity. BCI can detect the patient's intention to move the hand even if they are not able to physically move it. Using BCI, patients control the FES by thinking to move their hand.

A BCI-FES therapy will provide a simultaneous training of neural pathways from the brain to the hand muscle (motor imagination/attempt) and from the muscle to the brain (electrical stimulation of muscles). This form of therapy could promote faster and more complete recovery

In this controlled study we aim to provide a BCI-FES therapy to both chronic and subacute tetraplegic patients over a period of 20 sessions and to access the functional and neurological outcome of the therapy. Five chronic patients (more than a year after the injury) will participate in a cross-over study as we do not expect that they will recover spontaneously without BCI-FES. Subacute patients will be receiving both a conventional therapy and BCI-FES so recovery can be caused by either of these two therapies. Therefore it is necessary to have a treatment and a control group. Each group will have 10 patients, age and injury matched. Both groups will receive the same amount of electrical stimulation but only the treatment group will voluntarily control the electrical stimulator using BCI. A control group will receive passive electrical stimulation of the same hand muscles but without using BCI.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom
    • Queen Elizabeth National Spinal Injuries Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• incomplete (ASIA B, C) tetraplegia with injury at level C4-C8
• aged between 18 and 70 years old
• a candidate suitable for the conventional therapy

Exclusion Criteria:

• Patients must not have presence of any neurological problem that might distort recording standard brain signal during motor imagination (example: brain damage, epilepsy, Parkinson disease and multiple sclerosis)
• Patients must not have cognitive impairments (hearing, vision and general inability to understand instructions)
• Patients must not suffer from recurring pressure sore which prevent patient from sitting for at least an hour
• Patients must not suffer from excessive spasm that would increase with electrical stimulation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active muscle stimulation; Muscle stimulation delivered by Brain Computer Interface	Device: BCI-FES; Brain computer Interface delivered Function Electrical Stimulation
Active Comparator: Passive muscle stimulation; FES will be delivered by therapist	Device: Passive muscle stimulation; Functional Electrical stimulation delivered by therapist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Muscle strength as measured by the Oxford manual test	Between initial and final assessment after up to 8 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in patients EEG before and after each treatment session	Measures will be taken at the beginning and end of each of the 20 treatment sessions	between beginning and end of each one hour treatment session
Difference in EEG between the treatment and the control group		Between initial and final assessment after up to 8 weeks of treatment
Difference in Somatosensory evoked potential between the treatment and control group		Between initial and final assessment after up to 8 weeks of treatment
Difference in somatosensory evoked potential before and after a treatment session		Between initial and final assessment after up to 8 weeks of treatment
Patient's experience of using BCI-FES	A questionnaire will collect information	Between initial and final assessment after up to 8 weeks of treatment
Quadriplegia index of function		Between initial and final assessment after up to 8 weeks of treatment
Range of movement of wrists and fingers		Between initial and final assessment after up to 8 weeks of treatment

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: University of Glasgow
• Investigators: Principal Investigator: Aleksandra Vuckovic, PhD, University of Glasgow

Publications and helpful links

General Publications

• Osuagwu BC, Wallace L, Fraser M, Vuckovic A. Rehabilitation of hand in subacute tetraplegic patients based on brain computer interface and functional electrical stimulation: a randomised pilot study. J Neural Eng. 2016 Dec;13(6):065002. doi: 10.1088/1741-2560/13/6/065002. Epub 2016 Oct 14.

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2013
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: April 30, 2013
• First Submitted That Met QC Criteria: May 8, 2013
• First Posted (Estimate): May 13, 2013

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: GN12NE574

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No