ClinicalTrials.gov
ClinicalTrials.gov Menu

BCI and FES for Hand Therapy in Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01852279
Recruitment Status : Recruiting
First Posted : May 13, 2013
Last Update Posted : August 21, 2017
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: BCI-FES Device: Passive muscle stimulation Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Brain Computer Interface Control of Functional Electrical Stimulation for a Hand Therapy in Tetraplegic Patients
Study Start Date : May 2013
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 Measures :
  1. Changes in patients EEG before and after each treatment session [ Time Frame: between beginning and end of each one hour treatment session ]
    Measures will be taken at the beginning and end of each of the 20 treatment sessions

  2. Difference in EEG between the treatment and the control group [ Time Frame: Between initial and final assessment after up to 8 weeks of treatment ]
  3. 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 ]
  4. 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 ]
  5. Patient's experience of using BCI-FES [ Time Frame: Between initial and final assessment after up to 8 weeks of treatment ]
    A questionnaire will collect information

  6. Quadriplegia index of function [ Time Frame: Between initial and final assessment after up to 8 weeks of treatment ]
  7. Range of movement of wrists and fingers [ Time Frame: Between initial and final assessment after up to 8 weeks of treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852279


Contacts
Contact: Aleksandra Vuckovic, PhD 44-141-330-3251 aleksandra.vuckovic@glasgow.ac.uk

Locations
United Kingdom
Queen Elizabeth National Spinal Injuries Unit Recruiting
Glasgow, United Kingdom
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
Investigators
Principal Investigator: Aleksandra Vuckovic, PhD University of Glasgow

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT01852279     History of Changes
Other Study ID Numbers: GN12NE574
First Posted: May 13, 2013    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries