Training to improve hand and arm function in people with spinal cord injuries
Neuromodulation Training for Upper Extremity Recovery for Chronic Cervical Spinal Cord Injury
This study is testing whether a new training program that combines physical exercises with electrical stimulation can help people with spinal cord injuries use their hands and arms better and improve their daily lives.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kessler Foundation Academic / other |
| Locations | 1 site (West Orange, New Jersey) |
| Trial ID | NCT04921592 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of combining activity-based recovery training with targeted spinal cord transcutaneous stimulation (scTS) to enhance the use of hands, arms, and core in individuals with chronic cervical spinal cord injuries. Participants will undergo physical evaluations, functional tests, and MRI scans to assess their condition. They will be randomized into groups receiving different intensities of training sessions that incorporate electrical stimulation to activate spinal cord pathways. The goal is to promote independence and improve quality of life without relying on assistive devices.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a cervical spinal cord injury lasting six months or more.
Not a fit: Patients who are ventilator-dependent or have significant unrelated medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance motor function and independence for patients with spinal cord injuries.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving motor function through activity-based training and electrical stimulation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age. * spinal cord injury for greater than or equal to 6 months. * spinal cord injury at a cervical neurologic level of injury. Exclusion Criteria: * ventilator dependent. * history of fractures. * pressure sore or skin issues. * history of illicit drug abuse. * history of cardiac, respiratory, bladder, renal or other medical disorder unrelated to spinal cord injury. * bladder Botox injections less than 12 months prior. * muscle Botox injections less than 12 months prior. * colostomy bag or urostomy. * implanted pump (i.e., baclofen pump, pain pump, etc). * If I am female: I am pregnant at the time of enrollment or planning to become pregnant during the course of the study. * unable to wean from anti-spasticity medication. * contraindications to MRI imaging (pacemaker, metallic foreign body, aneurysm clip, etc.)
Where this trial is running
West Orange, New Jersey
- Kessler Foundation — West Orange, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Gail F Forrest, PhD — Kessler Foundation
- Study coordinator: LeighAnn Martinez, BA
- Email: lmartinez@kesslerfoundation.org
- Phone: 973.324.3557
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.