Non-Invasive Stimulation for Spinal Cord Injury

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Kathleen Friel

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this study is to determine if spinal excitability is increased with a Spinal Associative Stimulation (SAS) protocol, and to determine the functional consequences of this technique on motor recovery.

Eligibility Criteria

This trial is for individuals with chronic spinal cord injuries (more than 6 months old) who still have some motor function in their ankle muscles. Participants must have an incomplete lesion as classified by the ASIA Impairment Scale and a traumatic cause for their injury.

Inclusion Criteria

My spinal cord injury is partially impairing my movement.

Treatment Details

The study is testing Spinal Associative Stimulation (SAS), which combines Transcranial Magnetic Stimulation (TMS) with Peripheral Nerve Stimulation to see if it can increase spinal excitability and improve motor recovery in participants.

3Treatment groups

Experimental Treatment

Active Control

Group I: SAS20Experimental Treatment1 Intervention

The paired stimulation (SAS) will be comprised of patient adjusted subthreshold TMS (80% of resting motor threshold over optimal site for soleus muscle), delivered 20ms prior to a peripheral nerve stimulus in the popliteal fossa and will be repeated at 0.1 Hz for 15 minutes (90 stimuli pairs).

Group II: SAS0Active Control1 Intervention

The paired stimulation (SAS) will be comprised of patient adjusted subthreshold TMS (80% of resting motor threshold over optimal site for soleus muscle), delivered 0ms prior to a peripheral nerve stimulus in the popliteal fossa and will be repeated at 0.1 Hz for 15 minutes (90 stimuli pairs).

Group III: SAS50Active Control1 Intervention

The paired stimulation (SAS) will be comprised of patient adjusted subthreshold TMS (80% of resting motor threshold over optimal site for soleus muscle), delivered 50ms prior to a peripheral nerve stimulus in the popliteal fossa and will be repeated at 0.1 Hz for 15 minutes (90 stimuli pairs).