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
| NCT ID | NCT06773286 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kessler Foundation |
| Condition | Spinal Cord Injury Cervical |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-04-08 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-04-08 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Gail Forrest, PhD
STUDY DIRECTOR
Kessler Foundation
Frequently Asked Questions
Who can join the NCT06773286 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Spinal Cord Injury Cervical. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06773286 currently recruiting?
Yes, NCT06773286 is actively recruiting participants. Contact the research team at fzhang@kesslerfoundation.org for enrollment information.
Where is the NCT06773286 trial being conducted?
This trial is being conducted at West Orange, United States.
Who is sponsoring the NCT06773286 clinical trial?
NCT06773286 is sponsored by Kessler Foundation. The principal investigator is Gail Forrest, PhD at Kessler Foundation. The trial plans to enroll 30 participants.