BCI and FES for Hand Therapy in Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional

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.
    

Intervention name(s): BCI-FES; Passive muscle stimulation
Intervention type(s): Device; Device
Intervention description(s): Brain computer Interface delivered Function Electrical Stimulation; Functional Electrical stimulation delivered by therapist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment