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Completed

NCT Number: NCT01852279

BCI and FES for Hand Therapy in Spinal Cord Injury

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Elizabeth National Spinal Injuries Unit

Glasgow, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BCI-FES

Device

Brain computer Interface delivered Function Electrical Stimulation

Passive muscle stimulation

Device

Functional Electrical stimulation delivered by therapist

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

NHS Greater Glasgow and Clyde

Other

Collaborators

  • University of Glasgow

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
May 13, 2013
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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