Improving upper limb function in people with cervical spinal cord injury
Improving Upper Limb Rehabilitation by Rebuilding Inter-limb Transfer of Motor Gains in Cervical SCI
This study is testing a new way to help people with cervical spinal cord injuries improve their arm movement by using a special brain stimulation technique along with practice.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 17 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06440538 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of paired neurostimulation combined with motor training on improving motor skills in individuals with cervical spinal cord injury (SCI). It focuses on enhancing inter-limb transfer, which is the ability for motor skills learned in one limb to benefit the opposite limb. The approach involves using a novel non-invasive neurostimulation technique called paired corticospinal-motor neuronal stimulation (PCMS) alongside contralateral motor training. The goal is to rebuild neural connections and improve upper limb function in patients with chronic cervical SCI.
Who should consider this trial
Good fit: Ideal candidates are individuals with cervical spinal cord injury at neurological levels C4 to C8, with some residual motor function in their hands and at least one year post-injury.
Not a fit: Patients with contraindications to neurostimulation methods or those with severe spasticity or other neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance upper limb motor function and independence for patients with cervical spinal cord injury.
How similar studies have performed: Previous studies have shown promise in using neurostimulation to enhance motor function, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Neurological Level of Injury C4, C5, C6, C7, C8 * American Spinal Injury Association Impairment Scale (AIS) C-D * greater than or equal to 1 year time post injury * residual motor sparing of bilateral FDI muscles, defined as medical research council (MRC) grade 2 to 5 Exclusion Criteria: * contraindications to transcranial magnetic stimulation (TMS) and peripheral nerve stimulation (PNS) including pacemaker, metal in the skull, seizure history, pregnancy, etc. * history of alcohol and/or drug abuse * current usage of medications that can potentially lower the seizure threshold such as bupropion, amphetamines, etc. * history of other neurological conditions such as stroke, Parkinson's, and traumatic brain injury (TBI) * active pressure ulcers to avoid disruption of ongoing medical treatments * participation of on-going upper-limb therapies to minimize confounding effects * excessive tone/spasticity (Modified Ashworth Scale \[MAS\] \>3) and severe contractures or soft tissue shortening at elbow/wrist/fingers
Where this trial is running
Cleveland, Ohio
- Lerner Research Institute; Cleveland Clinid Foundation — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Ela Plow, PhD — The Cleveland Clinic
- Study coordinator: Kyle J O'Laughlin, MS
- Email: olaughk@ccf.org
- Phone: 216-445-6728
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.