Spinal Cord Stimulation Assisted by Motor Rehabilitation Training for Restoring Motor Function After Spinal Cord Injury

NARecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

April 19, 2023

Primary Completion Date

May 1, 2025

Study Completion Date

May 1, 2026

Conditions
Spinal Cord Injuries
Interventions
PROCEDURE

Spinal cord stimulation surgery (device) and motor rehabilitation

The first part of the study will involve a preoperative evaluation. Participants' clinical history, neurological, neurophysiological and advanced brain/spine MRI examination will be assessed (Part 1). Subsequently, participants will undergo spinal cord stimulation surgery which involves the implantation of a medical device (Part 2). After the surgery, the research participants will be hospitalized at the Neurosurgery Unit (10 days) to monitor the incision site (Part 3). Thereafter, the patients will be moved (for at least 6 weeks) to the Rehabilitation Unit in order to identify appropriate stimulation parameters for inducing stepping and standing and for starting training. The combination of epidural stimulation with manual step/stand training will be thus evaluated (Part 4). Patients will be finally assessed by clinical evaluation, advanced MRI and neurophysiological examination to study the brain, spine and peripheral functions after six months (Part 5).

Trial Locations (1)

20132

RECRUITING

IRCCS Ospedale San Raffaele, Milan

All Listed Sponsors
collaborator

Scuola Superiore Sant'Anna di Pisa

OTHER

lead

IRCCS San Raffaele

OTHER