Epidural Electrical Stimulation to Restore Standing and Walking in Patients With Chronic Paralysis Due to Spinal Cord Injury: A Study on Motor Recovery, Spasticity Reduction, and Quality of Life Improvement Through Neuromodulation and Intensive Rehabilitation

NARecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

January 28, 2022

Primary Completion Date

December 10, 2026

Study Completion Date

January 10, 2027

Conditions
Spinal Cord Injuries (SCI)Paralysis, Lower Limbs
Interventions
PROCEDURE

Epidural Electrical Stimulation (EES) using an implanted paddle lead and pulse generator combined with a 12-month intensive rehabilitation program.

The intervention consists of surgical implantation of an epidural electrical stimulator using a paddle lead (Medtronic Specify 5-6-5) placed in the lumbar epidural space and a subcutaneously implanted pulse generator (Medtronic Intellis). After a one-month recovery and device calibration period, the stimulator is activated during a 12-month intensive rehabilitation program. Patients receive electrical stimulation during five supervised physiotherapy sessions per week. Stimulation parameters-including pulse width, frequency, and amplitude-are individually optimized based on intraoperative neurophysiological monitoring and ongoing clinical assessments, with the goal of enhancing gait recovery, reducing spasticity, and improving overall motor function and quality of life.

Trial Locations (1)

05403010

RECRUITING

University of São Paulo General Hospital, São Paulo

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medtronic

INDUSTRY

lead

University of Sao Paulo General Hospital

OTHER

NCT06847295 - Epidural Electrical Stimulation to Restore Standing and Walking in Patients With Chronic Paralysis Due to Spinal Cord Injury: A Study on Motor Recovery, Spasticity Reduction, and Quality of Life Improvement Through Neuromodulation and Intensive Rehabilitation | Biotech Hunter | Biotech Hunter