Using spinal cord stimulation and activity training to improve arm function in patients with cervical spinal cord injuries
Establishing the Feasibility, Safety, and Efficacy of Spinal Cord Transcutaneous Stimulation with Activity-based Training for Upper Extremity Function Recovery in Individuals with Acute to Subacute Tetraplegia
This study is testing if combining spinal cord stimulation with activity training can help improve arm function in people with cervical spinal cord injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Kessler Foundation Academic / other |
| Locations | 1 site (West Orange, New Jersey) |
| Trial ID | NCT06773286 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and effectiveness of combining spinal cord transcutaneous stimulation (scTS) with activity-based training (ABT) for individuals with acute to subacute cervical spinal cord injuries. Participants will undergo a 10-day regimen of this combined intervention in an inpatient rehabilitation setting, with their progress compared to a sham control and an ABT-only group. The study aims to assess not only the safety and feasibility of the intervention but also its potential to enhance upper extremity function and explore underlying neurophysiological mechanisms. The trial will evaluate changes in cortical and spinal excitability as part of the outcome measures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced a traumatic cervical spinal cord injury within the last 8 weeks and have some degree of motor dysfunction in their hands.
Not a fit: Patients with severe spasticity, cognitive deficits, or those who are medically unstable may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve hand and arm function for patients recovering from cervical spinal cord injuries.
How similar studies have performed: While the combination of scTS and ABT is a novel approach, similar studies have shown promise in enhancing rehabilitation outcomes for spinal cord injury patients.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
West Orange, New Jersey
- Kessler Foundation — West Orange, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Fan Zhang, PhD
- Email: fzhang@kesslerfoundation.org
- Phone: 4015362070
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.