Epidural Electrical Stimulation for Motor and Functional Recovery in Patients With Chronic Paralysis Due to Spinal Cord Injury: A Prospective Study Evaluating Gait Restoration, Spasticity Reduction, Pain Management, and Quality of Life Improvements Through Neuromodulation and Intensive Rehabilitation

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• Adult patients aged 18 to 50 years.

• Stable spinal cord injury (SCI) at least 6 months post-injury.

• Classified as ASIA A or B with inability to stand or walk.

• Injury located between C7 and T10.

• Intact segmental reflexes below the level of injury.

• Ability to understand and sign the informed consent form.

• Willingness and capability to attend daily physiotherapy sessions.

• Clinically stable overall health as determined by the investigators.

Locations
Other Locations
Brazil
University of São Paulo General Hospital
RECRUITING
São Paulo
Contact Information
Primary
Matheus Moreli Porceban, MD, PhD student
matheus.porceban@hc.fm.usp.br
+5511999157497
Backup
Guilherme Alves Lepski, MD, PhD
g.lepski@hc.fm.usp.br
+5511997858947
Time Frame
Start Date: 2022-01-28
Estimated Completion Date: 2027-01-10
Participants
Target number of participants: 10
Treatments
Experimental: Epidural Electrical Stimulation + Intensive Rehabilitation Arm
Patients enrolled in this arm will undergo surgical implantation of an epidural spinal cord stimulator (Medtronic Specify 5-6-5 paddle lead and Intellis pulse generator) followed by a 12-month intensive rehabilitation program. After a one-month post-operative recovery period, electrical stimulation will be activated during five supervised physiotherapy sessions per week. The intervention combines neuromodulation with targeted motor and balance exercises to facilitate gait recovery, reduce spasticity, alleviate pain, and enhance overall quality of life. Outcomes will be monitored through clinical scales, surface electromyography, and video documentation, with patients serving as their own controls by comparing pre- and post-implantation performance.
Sponsors
Leads: University of Sao Paulo General Hospital
Collaborators: Medtronic

This content was sourced from clinicaltrials.gov