Spinal Cord Associative Plasticity Study

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

September 10, 2021

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Cervical Spinal Cord InjuryTetraplegia/TetraparesisCervical Myelopathy
Interventions
PROCEDURE

Non-invasive pairing of cortical and spinal stimulation

Transcranial magnetic stimulation (TMS) threshold, Transcutaneous spinal cord stimulation (TSCS) threshold, and peripheral and central motor conduction times will be determined. In the active intervention, two TMS pulse intensities will be tested: 90% and 120% of motor threshold. Two conditioning TSCS pulse intensities will be tested: 50% and 90% of response threshold. Single TSCS pulses will be delivered timed to arrive in the cervical spinal cord at a range of intervals from 30ms before to 30ms after the TMS pulse. The control conditions will include TMS only TSCS only and non-convergent pairing latency pairing stimulation.

PROCEDURE

Intraoperative pairing of cortical and spinal stimulation

The surgeon will position spinal cord electrodes on the epidural surface one level rostral (typically C4/C5) to the site of myelopathy. Spinal and cortical thresholds will be determined. Investigator will then test the immediate effects of paired stimulation by stimulating the cortex at 120% of threshold and the spinal cord at 90% of threshold at various latencies relative to the time of synchronous convergence. The control intervention will include cortical only (120%) spinal only (90%) and non-convergent latency pairing stimulation.

PROCEDURE

Non-invasive repeated pairing of cortical and spinal stimulation (SCAP)

Thresholds will be determined as above. Immediately prior to repetitive pairing, a set of 12 TMS pulses will be delivered at 120% threshold to measure the baseline cortical MEP. Likewise, a set of 12 TSCS pulses will be delivered at 120% of threshold to establish the baseline spinal MEP. For each session, baseline maximal pinch dynamometry will be determined. Immediately after the SCAP protocol is completed, response to TMS, TSCS, and maximal pinch dynamometry will be measured again every 10 minutes over the subsequent hour. The control conditions will include TMS only TSCS only and non-convergent pairing latency pairing stimulation.

PROCEDURE

Intraoperative repeated pairing of cortical and spinal stimulation (SCAP)

Intraoperative: Spinal and cortical thresholds will be determined. Immediately prior to repetitive pairing, a set of 12 baseline cortical pulses and 12 baseline spinal pulses will be delivered at 120% threshold. SCAP protocol will be applied, both of which have been successful at inducing lasting effects in the rat. After pairing, cortical stimulation at 120% of threshold and spinal cord stimulation at 120% threshold will be repeated every 10 minutes for the duration of surgery. In a subset of patients repeated pairing will be conducted with a latency that investigator does not expect will induce SCAP, or with electrodes placed over the ventral epidural surface. The control intervention will include repeated pairing at a non-convergent latency, as well as pairing of cortical stimulation with ventral epidural stimulation.

PROCEDURE

Intraoperative repeated pairing of cortical and spinal stimulation (SCAP) at or below myelopathic region

As per the intervention 'Intraoperative repeated pairing of cortical and spinal stimulation (SCAP)' targeted at or below myelopathic region.

Trial Locations (3)

10029

RECRUITING

Bronx Veterans Medical Research Foundation, Inc, New York

10032

RECRUITING

Columbia University Irving Medical Center, New York

10065

RECRUITING

Weill Cornell Medicine, New York

All Listed Sponsors
collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

collaborator

Weill Medical College of Cornell University

OTHER

collaborator

Bronx Veterans Medical Research Foundation, Inc

OTHER

lead

Columbia University

OTHER