Spinal Cord Associative Plasticity (SCAP)
Background
- People with cervical SCI have reduced connections in nerve circuits between the brain and the hands. Activating spared nerve circuits could be a way to improve recovery.
- We are testing different combinations of magnetic and electrical brain and spinal cord stimulation to see if we can improve hand function by activating spared nerve connections.
- Preliminary results demonstrate that precisely pairing noninvasive brain and spinal cord stimulation has the potential to facilitate nerve responses in the upper extremity.
- Note: This is a research study. This study is testing for temporary changes (up to several days) in nerve transmission and hand function. If we see temporary changes in this study, then future studies would focus on how to prolong that effect.
Eligibility Criteria (summary)
- Age 18-85 yo with chronic cervical SCI, occurred greater than 12 months ago
- Ability to at least slightly move muscles of left or right hand & fingers
- No history of severe traumatic brain injury (TBI); not ventilator-dependent; no implanted stimulators or cardiac pacemaker/defibrillator, no epilepsy
- Other eligibility criteria will be screened in person to make sure it is safe for you to participate
Procedures
Up to 7 visits, up to 3-4 hours each
The first visit will be a screening visit to determine eligibility.
What you should know
- Electrical and magnetic stimulation can feel like a ‘shock’ that is temporarily uncomfortable at higher pulse strength
- The main risk of magnetic brain stimulation is seizure. BUT:
- The exclusion criteria are designed to prevent anyone at risk of seizure from participating.
- When performed according to these recommendations, the risk of seizure is less than 1 in 1,000.
- If you are uncomfortable at any time for any reason, we can stop the procedures. There is no obligation!!
Investigator
Noam Y. Harel, MD, PhD
Study ID
SCAP
Contact
Sig Sigafose or Francisco Castano
Clinicaltrials.gov Identifier
NCT05163639