Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

March 1, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Spinal Cord InjuriesSpinal Cord InjurySpinal Cord Injury CervicalSpinal Cord Injury Thoracic
Interventions
DEVICE

Transcutaneous spinal stimulation at 100 Hz

Transcutaneous spinal stimulation (TSS) is a non-invasive neuromodulation method that uses electrical currents to stimulate sensory fibers. The procedure involves placing surface electrodes midline on the lower back (T11-12 spinal processes) and on each side of the belly button. The stimulation frequency during the intervention is 100 Hz, performed at a sub-motor threshold for 30 minutes.

DEVICE

Transcutaneous spinal stimulation at 50 Hz

Transcutaneous spinal stimulation (TSS) is a non-invasive neuromodulation method that uses electrical currents to stimulate sensory fibers. The procedure involves placing surface electrodes midline on the lower back (T11-12 spinal processes) and on each side of the belly button. The stimulation frequency during the intervention is 50 Hz, performed at a sub-motor threshold for 30 minutes.

COMBINATION_PRODUCT

Transcutaneous spinal stimulation at 50 Hz and single dose of baclofen

"Transcutaneous spinal stimulation (TSS) is a non-invasive neuromodulation method that uses electrical currents to stimulate sensory fibers. The procedure involves placing surface electrodes midline on the lower back (T11-12 spinal processes) and on each side of the belly button. The stimulation frequency during the intervention is 50 Hz, performed at a sub-motor threshold for 30 minutes.~Study participants will receive a single dose of baclofen, a centrally-acting muscle relaxant belonging to the class of gamma-aminobutyric acid (GABA) analogs. Its primary mechanism involves acting on the GABA receptors in the brain and spinal cord to decrease spasticity. Participants will receive baclofen orally at a single dose of 10 mg."

COMBINATION_PRODUCT

Transcutaneous spinal stimulation at 50 Hz and single dose of tizanidine

"Transcutaneous spinal stimulation (TSS) is a non-invasive neuromodulation method that uses electrical currents to stimulate sensory fibers. The procedure involves placing surface electrodes midline on the lower back (T11-12 spinal processes) and on each side of the belly button. The stimulation frequency during the intervention is 50 Hz, performed at a sub-motor threshold for 30 minutes.~Study participants will receive a medication called tizanidine, which is an alpha-2 adrenergic agonist. This medication works by inhibiting presynaptic motor neurons, resulting in a reduction of muscle spasticity. It is commonly used to manage spasticity caused by neurological disorders. Each participant will be given a single oral dose of 4 mg of tizanidine as part of this trial."

DEVICE

Sham transcutaneous spinal stimulation

Sham Transcutaneous spinal stimulation (TSS) involves placing two surface electrodes midline on the lower back (T11-12 spinal processes). The stimulation frequency during the intervention is 50 Hz, performed for 30 minutes.

Trial Locations (2)

39216

RECRUITING

Methodist Rehabilitation Center, Jackson

RECRUITING

University of Mississippi Medical Center, Jackson

All Listed Sponsors
collaborator

Methodist Rehabilitation Center

OTHER

collaborator

The Craig H. Neilsen Foundation

OTHER

lead

University of Mississippi Medical Center

OTHER