Multisite Transspinal Stimulation for Augmenting Recovery in Spinal Cord Injury

NARecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

June 30, 2028

Study Completion Date

June 30, 2028

Conditions
Spinal Cord Injuries (Complete and Incomplete)
Interventions
DEVICE

Multisite transspinal stimulation at rest

The intervention, combined cervical and lumbar transspinal stimulation, will be used for the first time to reconnect the spared neuronal pathways of the injured human spinal cord. The intervention will be administered while at rest lying on the back or during robotic gait training. Cervical and lumbar transspinal stimulation will be delivered via surface active electrodes placed on the back of the neck and on low back, and four returning electrodes placed on each clavicle and iliac crest.

DEVICE

Multisite transspinal stimulation during robotic gait training

The intervention, combined cervical and lumbar transspinal stimulation, will be administered during robotic gait training. Cervical and lumbar transspinal stimulation will be delivered via surface active electrodes placed on the back of the neck and on low back, and four returning electrodes placed on each clavicle and iliac crest while participants step with the help of the Lokomat 6 Pro, a robotic device that helps the legs step. Locomotor training will depend on the ability of each participant to step without foot dragging. Over the training course, we will adjust the body weight support, ankle straps position, and leg guidance force. The tension of the ankle straps will be adjusted based on the right and left tibialis anterior muscle strength evaluated every 2 weeks. Body weight support and leg guidance force will be adjusted based on presence or absence of knee buckling during standing.

Trial Locations (1)

10314

RECRUITING

College of Staten Island (Building 5N-218), Staten Island

All Listed Sponsors
lead

Maria Knikou, PT, MBA, PhD

OTHER

NCT07204184 - Multisite Transspinal Stimulation for Augmenting Recovery in Spinal Cord Injury | Biotech Hunter | Biotech Hunter