10
Participants
Start Date
April 19, 2023
Primary Completion Date
May 1, 2025
Study Completion Date
May 1, 2026
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).
RECRUITING
IRCCS Ospedale San Raffaele, Milan
Scuola Superiore Sant'Anna di Pisa
OTHER
IRCCS San Raffaele
OTHER