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BCI and FES for Hand Therapy in Spinal Cord Injury

NCT ID: NCT01852279

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-08

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Spinal Cord Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active muscle stimulation

Muscle stimulation delivered by Brain Computer Interface

Group Type EXPERIMENTAL

BCI-FES

Intervention Type DEVICE

Brain computer Interface delivered Function Electrical Stimulation

Passive muscle stimulation

FES will be delivered by therapist

Group Type ACTIVE_COMPARATOR

Passive muscle stimulation

Intervention Type DEVICE

Functional Electrical stimulation delivered by therapist

Interventions

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BCI-FES

Brain computer Interface delivered Function Electrical Stimulation

Intervention Type DEVICE

Passive muscle stimulation

Functional Electrical stimulation delivered by therapist

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Glasgow

OTHER

Sponsor Role collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aleksandra Vuckovic, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Locations

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Queen Elizabeth National Spinal Injuries Unit

Glasgow, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 27739405 (View on PubMed)

Other Identifiers

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GN12NE574

Identifier Type: -

Identifier Source: org_study_id