Noninvasive brain and nerve stimulation to improve hand grasp after cervical spinal cord injury
Neuromodulation to Improve Grasping Function After Spinal Cord Injury
This trial will test whether combining noninvasive brain stimulation (iTBS) and paired corticospinal-motoneuronal stimulation with hand exercises can improve grasping in people with chronic cervical spinal cord injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | State University of New York at Buffalo Academic / other |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT07433959 on ClinicalTrials.gov |
What this trial studies
The protocol pairs intermittent theta burst stimulation (iTBS) applied to primary motor cortex with paired corticospinal-motoneuronal stimulation (PCMS) of peripheral nerves to strengthen late corticospinal descending signals. In Part 1, 30 participants complete two randomized sessions comparing the combined stimulation approach to control/sham to measure immediate neurophysiological effects. In Part 2, 24 participants are randomized to receive either the combined stimulation protocol or sham stimulation alongside a program of long-term hand grasp training to measure functional gains. Outcomes include motor-evoked potentials and measures of hand motor function.
Who should consider this trial
Good fit: Ideal candidates are adults 18–75 with chronic (≥1 year) cervical incomplete spinal cord injury at C8 or above who have measurable motor-evoked potentials in at least one first dorsal interosseous (FDI) muscle.
Not a fit: People with uncontrolled medical conditions, a history of seizures, metal skull implants, or those taking medications that lower the seizure threshold are unlikely to be eligible or to benefit from the stimulation protocols.
Why it matters
Potential benefit: If successful, the approach could improve hand strength and grasp function, increasing independence in daily activities for people with cervical incomplete spinal cord injury.
How similar studies have performed: Previous small human and animal studies have shown that PCMS and iTBS can enhance corticospinal plasticity, but combining both techniques with long-term motor training in this population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: For individuals with SCI: * Ages 18-75 years * Chronic SCI (≥1 year of injury) * Cervical injury at C8 or above * Individuals who have MEP responses in at least one FDI muscle Exclusion Criteria: * Uncontrolled medical problems including pulmonary or cardiovascular disease * Premorbid, ongoing major depression or psychosis, altered cognitive status * History of head injury or stroke * Metal plate in skull * History of seizures * Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs * Pregnant females * Individuals who suffer from a spinal cord disease such as spinal stenosis, spinal bifida or herniated cervical
Where this trial is running
Buffalo, New York
- The State University of New York at Buffalo — Buffalo, New York, United States (Recruiting)
Study contacts
- Study coordinator: Hang Jin Jo, PhD
- Email: hangjinj@buffalo.edu
- Phone: 716-829-2905
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.