BCI and FES for Hand Therapy in Spinal Cord Injury
Primary Purpose
Spinal Cord Injury
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
BCI-FES
Passive muscle stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury
Eligibility Criteria
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.
Sites / Locations
- Queen Elizabeth National Spinal Injuries Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Active muscle stimulation
Passive muscle stimulation
Arm Description
Muscle stimulation delivered by Brain Computer Interface
FES will be delivered by therapist
Outcomes
Primary Outcome Measures
Muscle strength as measured by the Oxford manual test
Secondary Outcome Measures
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
Difference in EEG between the treatment and the control group
Difference in Somatosensory evoked potential between the treatment and control group
Difference in somatosensory evoked potential before and after a treatment session
Patient's experience of using BCI-FES
A questionnaire will collect information
Quadriplegia index of function
Range of movement of wrists and fingers
Full Information
NCT ID
NCT01852279
First Posted
April 30, 2013
Last Updated
December 17, 2020
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
1. Study Identification
Unique Protocol Identification Number
NCT01852279
Brief Title
BCI and FES for Hand Therapy in Spinal Cord Injury
Official Title
Brain Computer Interface Control of Functional Electrical Stimulation for a Hand Therapy in Tetraplegic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 8, 2013 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active muscle stimulation
Arm Type
Experimental
Arm Description
Muscle stimulation delivered by Brain Computer Interface
Arm Title
Passive muscle stimulation
Arm Type
Active Comparator
Arm Description
FES will be delivered by therapist
Intervention Type
Device
Intervention Name(s)
BCI-FES
Intervention Description
Brain computer Interface delivered Function Electrical Stimulation
Intervention Type
Device
Intervention Name(s)
Passive muscle stimulation
Intervention Description
Functional Electrical stimulation delivered by therapist
Primary Outcome Measure Information:
Title
Muscle strength as measured by the Oxford manual test
Time Frame
Between initial and final assessment after up to 8 weeks of treatment
Secondary Outcome Measure Information:
Title
Changes in patients EEG before and after each treatment session
Description
Measures will be taken at the beginning and end of each of the 20 treatment sessions
Time Frame
between beginning and end of each one hour treatment session
Title
Difference in EEG between the treatment and the control group
Time Frame
Between initial and final assessment after up to 8 weeks of treatment
Title
Difference in Somatosensory evoked potential between the treatment and control group
Time Frame
Between initial and final assessment after up to 8 weeks of treatment
Title
Difference in somatosensory evoked potential before and after a treatment session
Time Frame
Between initial and final assessment after up to 8 weeks of treatment
Title
Patient's experience of using BCI-FES
Description
A questionnaire will collect information
Time Frame
Between initial and final assessment after up to 8 weeks of treatment
Title
Quadriplegia index of function
Time Frame
Between initial and final assessment after up to 8 weeks of treatment
Title
Range of movement of wrists and fingers
Time Frame
Between initial and final assessment after up to 8 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksandra Vuckovic, PhD
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth National Spinal Injuries Unit
City
Glasgow
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
27739405
Citation
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.
Results Reference
derived
Learn more about this trial
BCI and FES for Hand Therapy in Spinal Cord Injury
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