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Spinal Cord Stimulation and Training for Cervical Spinal Cord Injury

This study is looking into how safe and practical it is to use spinal cord transcutaneous stimulation (scTS), which is stimulation applied through the skin to the spinal cord, along with activity-based training (ABT) for people with recent (acute to subacute) cervical spinal cord injury. The goal is to see if this combination can help improve the use of your hands and arms during inpatient rehabilitation. Participants will receive either active scTS with ABT, a sham (inactive) scTS with ABT, or ABT alone. To join, you must be between 18 and 75 years old, have had a cervical spinal cord injury within the last 8 weeks, and have some difficulty with hand movement. The study will measure changes in pain and skin integrity daily, and how many participants complete the study over 3 weeks.

Study design
This is an interventional study with a planned enrollment of 30 participants. It is a randomized, sham-controlled trial comparing three different approaches.
What's involved
Participants will receive their assigned intervention for 10 days. Pain and skin integrity will be checked before and after each daily session.
Compensation
Not stated in the trial record.
Follow-up
The study completion rate will be measured from enrollment to a post-intervention assessment at 3 weeks.

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NCT06773286

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
NAAges 18–75InterventionalTreatment
Kessler Foundation
~30 participants
Updated 2025-01-14 on ClinicalTrials.gov
What's tested:Active StimulationShamTraining only

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change of pain before and after daily intervention
Measured over From the beginning to the end of each intervention session at 30 minutes
+2 more outcomes measured

Conditions

Spinal Cord Injury Cervical

Explore related trials

Spinal Cord Injury

Where it's being run

1 sites across 1 states
New Jersey1

Study leadership

  • Gail Forrest, PhD · STUDY_DIRECTOR · Kessler Foundation

Who to contact

Fan Zhang, PhD
[email protected]
4015362070
Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Change of pain before and after daily interventionFrom the beginning to the end of each intervention session at 30 minutes

    Subjects will be asked to rate their pain intensity using an 11-point Numerical Rating Scale (i.e. 0-10), before and after each intervention session. The change in pain will be documented.

  • Change of skin integrity before and after daily intervention sessionFrom the beginning to the end of each intervention session at 30 minutes

    Skin integrity under electrode placement site will be assessed by a clinician before and after each session, any change i.e., redness, swelling, breakdown, will be recorded.

  • Study completion rateFrom enrollment to the post-intervention assessment at 3 weeks

    Study completion rate will be calculated at post-intervention by dividing the number of participants who will be present at these time points by the number of individuals who are enrolled and begin the intervention.