Upper Limb Rehabilitation Using Non-invasive Spinal Cord Stimulation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorCentre for Interdisciplinary Research in Rehabilitation of Greater Montreal

About this trial

The goal of this RCT study is to evaluate if combining activity-based therapy (ABT) with transcutaneous spinal cord stimulation (tSCS) can improve recovery of arm and hand movement in people with cervical spinal cord injury (SCI). As secondary aims, the study will also investigate at how this combination approach affects the cortical changes in the somatosensory and motor areas of the brain, as well as in the spinal cord and whether it helps participants use their arms more in daily life.

The main questions relevant to this study are:

1. Can the combination of ABT + tSCS improve motor and sensory functions of the arms and hands more than ABT alone during the sub-acute stage after SCI? 2. Does ABT + tSCS induce neuroplasticity, that is, changes in the brain and spinal cord activity linked to motor and sensory functions? 3. Do participants who receive ABT + tSCS report greater use of their arms in daily activities compared to those who receive ABT only?

In this study, participants will:

* Receive either ABT + tSCS or ABT + sham stimulation (a low-intensity current that does not facilitate the movements) * Take part in 20 training sessions over 6-8 weeks (3 times per week, 45 min of active training each). During this, they will perform strengthening, task-based training, and mental imagery exercises with a therapist. * Complete clinical tests and neurophysiological assessments (transspinal electrical stimulation, electroencephalography and transcranial magnetic stimulation) at three time points-- at the start, after training, and one month later to measure recovery and brain activity changes.

Researchers will compare the assessment outcomes across the three time points.

Eligibility criteria

Qualifiers

quadraplegic participants with a subacute spinal cord injury (sSCI), defined as the stage of spinal cord damage occurring between 1 week and 6 months post-injury, that fall within the period of at least one year post-injury

16 years old or above

have a lesion between above T2

residual upper limb movement

Disqualifiers

have a pacemaker

have active cancer on stimulation site or metastatic cancer

have unstable health conditions

have unhealed wound, scar or pain which makes positioning of the electrodes impossible

Trial design

Treatments tested in this trial

  • Protocol 1: Combination of activity-based therapy and sham spinal cord stimulation
  • Protocol 2: Combination of activity-based therapy and facilitatory transcutaneous spinal cord stimulation

Treatment groups

40 Participants
are divided into 2 treatment groups