NCT06847295: EPISTIM-SCI

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

Recruiting now NA Last updated 26 February 2025

What this trial tests

NA trial testing Epidural Electrical Stimulation (EES) using an implanted paddle lead and pulse generator combined with a 12-month intensive rehabilitation program. in Spinal Cord Injuries (SCI) in 10 participants. Currently enrolling.

Timeline

28 January 2022

Primary endpoint
10 December 2026

10 January 2027

Quick facts

Lead sponsor	University of Sao Paulo General Hospital
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	28 January 2022
Primary completion	10 December 2026
Estimated completion	10 January 2027
Sites	1 location across Brazil

Drugs / interventions tested

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

Conditions studied

• Spinal Cord Injuries (SCI) — all drugs for Spinal Cord Injuries (SCI) →
• Paralysis, Lower Limbs — all drugs for Paralysis, Lower Limbs →

Sponsor

University of Sao Paulo General Hospital

Who can join

Adults 18 to 50, any sex, with Spinal Cord Injuries (SCI) or Paralysis, Lower Limbs. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Spinal cord injury (SCI) is a major cause of morbidity and disability worldwide, significantly impacting patients' quality of life and functional independence. Despite advances in rehabilitation therapies, many individuals with SCI remain unable to stand or walk. Epidural electrical stimulation (EES) has emerged as a promising neuromodulation therapy to restore motor function in individuals with chronic paralysis.

This prospective clinical study aims to evaluate the efficacy and safety of EES in patients with chronic SCI who have lost the ability to stand or walk. The primary objective is to assess late-stage gait recovery following the implantation of an epidural spinal cord stimulator, using validated clinical scales such as the Fugl-Meyer Assessment - Lower Extremity (FMA-LE) and BMCA VRI.

Secondary objectives include evaluating:

The ability to stand independently (measured by the Berg Balance Scale). Improvements in walking capacity, with or without assistance. Changes in spasticity induced by EES (Modified Ashworth Scale). Reduction in pain perception (DN4, Brief Pain Inventory \[BPI\], Pain Disability Index \[PDI\]).

Improvements in neurogenic bladder and bowel dysfunction (NBSS and NBDS). Enhancements in quality of life (SCI-QOL, WHOQOL-BREF) and mood (Beck Depression Inventory \[BDI\]).

The study will recruit 10 adult patients (ages 18-50) with chronic, stable SCI (≥6 months post-injury) classified as ASIA A or B, with lesions between C7 and T10 and intact segmental reflexes below the injury level. Participants will undergo an intensive 3-month pre-implant rehabilitation program to maximize their baseline motor potential.

Following this period, eligible patients will receive surgical implantation of an epidural spinal cord stimulator (Medtronic Specify 5-6-5 paddle lead and Intellis pulse generator). After a 1-month post-surgical recovery period, patients will engage in a 12-month intensive rehabilitation protocol (5 supervised sessions per week), with the stimulator activated to facilitate motor recovery.

Patients will be assessed monthly through clinical evaluations and surface electromyography (EMG) to measure motor control improvements. Outcomes will be compared before and after EES implantation to determine the effectiveness of the intervention.

This study seeks to provide further evidence on the potential of epidural electrical stimulation in restoring standing and walking abilities in individuals with SCI. If successful, it could contribute to expanding treatment options for patients with chronic paralysis.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Spinal Cord Stimulation for Pain Management Following Spinal Cord Injury: A Systematic Review.
   Gallacher DM, Suarez M, Jevotovsky DS, Oehlermarx W, et al · · 2026 · PMID 41938223 · DOI 10.2147/jpr.s573333
2. Time Course of Motor Improvement by Epidural Stimulation After Spinal Cord Injury: An Interim Analysis of a Phase II Trial.
   Mm P, Lg A, E G, C P, et al · · 2025 · PMID 40994969 · DOI 10.1177/11795735251379220