Combining Spinal Cord Transcutaneous Stimulation and Activity-based Training in Inpatient Rehabilitation to Facilitate Upper Limb Function of Individuals with Acute to Subacute Cervical Spinal Cord Injury

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKessler Foundation

About this trial

The purpose of this clinical trial is to understand the safety and practicality of using spinal cord transcutaneous (through the skin) stimulation in an inpatient setting as well as how the combination of activity-based training (ABT) and spinal cord transcutaneous stimulation (scTS) can improve participants' ability to use their hands, arms, and trunk in an inpatient rehabilitation program. The main questions it aims to answer are:

* Is the combination of spinal cord transcutaneous stimulation and ABT is safe and practical when applied to individuals with acute to subacute cervical SCI during inpatient rehabilitation? * How the combined intervention can improve hand and arm function when applied to those individuals? The investigators will assess the safety, feasibility, and preliminary efficacy of the combined intervention and compare to a sham control (sham stimulation combined with ABT) and a ABT only group to see if the combined intervention can lead to greater function recovery.

Participants will:

* Receive one type of the three intervention (scTS+ABT, sham scTS+ABT, or ABT only) for 10 sessions with 30 mins/session over 2 weeks. * Receive assessment before, during, and immediately after the intervention, and at 1-month, 2-month, and 3-month follow-up visits.

Eligibility criteria

Qualifiers

must be at least 18 years of age.

must have had a spinal cord injury for less than or equal to 8 weeks.

must have a traumatic cervical SCI with lesions (AIS A or B, C5-C7).

must have some degree of motor dysfunction in the hand (bilateral UE motor score <25).

Disqualifiers

have a history of seizures, head trauma and/or cognitive deficit

have surgically implanted foreign bodies such as a pacemaker, metal plate in the skull, and metal inside the skull

have a pressure sore or skin issues.

have severe spasticity.

Trial design

Treatments tested in this trial

  • Active Stimulation
  • Sham
  • Training only

Treatment groups

30 Participants
are divided into 3 treatment groups

Sponsors and collaborators