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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Spinal Cord Injury Cervical

In brief

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.

Key facts

Study ID

NCT06773286

Run by

Kessler Foundation

People needed

30

Starts

2024-04-08

Expected to finish

2025-12-01

Last updated by the study team

2025-01-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• must be medically stable enough to participate in activity-based recovery training.
• must be able to tolerate spinal cord transcutaneous stimulation, as determined by study staff.
• must have ability to understand and the willingness to sign an informed consent.

You may not qualify if…

• 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.
• in medically unstable condition.
• have a history of illicit drug abuse.
• have a history of medical disorders of my heart, lungs, bladder, kidneys or other parts of my body that are unrelated to my spinal cord injury.
• unable or unwilling to wean from anti-spasticity medication (for an example: baclofen, Xeomin, and Lioresal).
• unable to meet the attendance requirements.
• currently enrolled in another interventional research study.
• unable to follow instructions and maintain alertness during assessments and training.

Where it is running

• Kessler Foundation — West Orange, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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