Neuromodulation After Spinal Cord Injury to Improve Limb Function
Part of paid clinical trials in Buffalo, New York.
- Sponsor
- State University of New York at Buffalo
- Study ID
- NCT06815601
- Status
- Recruiting
Conditions
- Spinal Cord Injury
- Spinal Cord Injury Cervical
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Accepted
Interventions
- rTMS — OTHERIntermittent theta burst stimulation (iTBS) will be utilized since they have been reported to have a cortical neuromodulatory effect. The iTBS protocol will be applied over primary motor cortex to investigate its effect on corticospinal excitability and functional outcome. Theta burst stimulation (TBS) consists of bursts of pulses containing 3 pulses at 50 Hz (3 pulses per second) repeated at 200 ms intervals (5 Hz). During iTBS, a 2 second train of TBS is repeated every 10 seconds (600 pulses in 190 seconds).
- Sham rTMS — OTHERSham iTBS protocols will be applied with the same parameters as in iTBS protocol. However, sham coil will be used.
- Motor training — BEHAVIORALThe motor training will be focused on participant's hand motor function such as grasping function.
Study Details
The University at Buffalo (UB) Department of Rehabilitation Sciences is looking for adult volunteers with and without spinal cord injuries for a study on hand movement. The goal of the study is to learn about how the brain, nerves, and muscles of the body are connected and perform everyday tasks. This may help us to develop ways to improve the hand functions of people with spinal cord injuries.
Key Dates
- Start date
- Apr 10, 2025
- Status verified
- Feb 2025
- Primary completion
- Jan 31, 2027
- Completion
- Jan 31, 2028
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Active Comparator: rTMSrTMS will be administered and functional and physiological outcomes will be measured before and after each intervention.
- Sham Comparator: Sham rTMSSham rTMS will be administered and functional and physiological outcomes will be measured before and after each intervention.
- Active Comparator: rTMS with motor trainingSubjects will receive the rTMS with motor training for long-term up to 50 sessions. Motor training involves hand motor training.
Primary Outcome Measure
Motor evoked potentials (MEP) [ Time Frame: For "rTMS" and "Sham rTMS", the time frame will be one day, before and after each session. For "rTMS with motor training", the time frame will be weekly up to 20 weeks. ]
Central Contacts
- Hang Jin Jo, PhD716-829-2905
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The Kimball Tower at The State University of New York at Buffalo | Buffalo | New York | 14214 | Hang Jin Jo, PhD (PRINCIPAL_INVESTIGATOR) |
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