Brain Plus Spinal Stimulation for Cervical SCI

Summary

The goal of this project is to strengthen residual corticospinal tract (CST) connections after partial injury using combined motor cortex and spinal cord stimulation to improve arm and hand function after spinal cord injury (SCI).

To do this, the investigators will test the combination of transcranial magnetic stimulation (TMS) with transcutaneous spinal direct current stimulation (tsDCS) in individuals with chronic cervical SCI.

Conditions

• Spinal Cord Injuries
• Spinal Cord Injury at C5-C7 Level
• Tetraplegia/Tetraparesis

Interventions

DEVICE

transcutaneous spinal direct current stimulation (tsDCS) - coronal

20 minutes of tsDCS will be delivered at 66% of maximum tolerated intensity with cathode over C5-C7 transverse process on target side, anode over C5-C7 transverse process on non-target side.

DEVICE

transcutaneous spinal direct current stimulation (tsDCS) - caudal

20 minutes of tsDCS will be delivered at 66% of maximum tolerated intensity with DCS cathode over \~T1-T4 posteriorly, anode over \~C5-T1 anteriorly

DEVICE

transcutaneous spinal direct current stimulation (tsDCS) - rostral

20 minutes of tsDCS will be delivered at 66% of maximum tolerated intensity with DCS cathode over \~C3-C5 posteriorly, anode over \~C5-T1 anteriorly

DEVICE

intermittent theta burst stimulation (iTBS)

3 minutes of iTBS (a form of repetitive TMS) will be delivered during a 5-minute interval of DCS

Sponsors & Collaborators

• New York State Department of Health

  collaborator OTHER_GOV

• Bronx VA Medical Center

  lead FED

Principal Investigators

• Noam Y Harel, MD, PhD · James J. Peters Veterans Affairs Medical Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-01-04

Primary Completion

2024-01-12

Completion

2024-01-13

FDA Device

Yes

Countries

• United States

Study Locations