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. Pairing stimulation of two parts of a spared circuit can target modulation more specifically to the intended nerve circuits.

We aim to enhance the demonstrated potential of transcutaneous spinal cord stimulation (TSCS) by synchronizing TSCS with transcranial magnetic stimulation (TMS) pulses in a fashion that triggers spinal cord associative plasticity (SCAP). Preliminary results demonstrate that precisely pairing TSCS and TMS has the potential to facilitate upper extremity responses to cortical stimulation.

Note: This is a research study testing for temporary changes in nerve transmission and volitional motor function. There is no guarantee of long-term benefit from this study. Any benefits seen in this study will be implemented in future studies attempting to augment that effect.
Eligibility Criteria (summary)
  • Age 18-75 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); no cardiac arrhythmia; 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 should you 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

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