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

NCT06847295 | Recruiting DMC FDA Device

• 1 other identifier: 30702520.6.0000.0068
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injuries (SCI); Paralysis, Lower Limbs

Keywords

Spinal Cord Injury; Spinal Cord Stimulation; Epidural Stimulation; Neuroplasticity; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Late-Stage Gait Recovery Assessed by the Fugl-Meyer Assessment for Lower Extremities

  Evaluates lower limb motor function using the Fugl-Meyer Assessment for Lower Extremities (0-86 points; higher scores indicate better function). Baseline measurements taken before epidural stimulator implantation

  Baseline and monthly evaluations over 12 months following epidural stimulator implantation

• Late-Stage Gait Recovery Assessed by the Brain Motor Control Assessment - Voluntary Response Index

  Evaluates voluntary motor control and coordination using the Brain Motor Control Assessment - Voluntary Response Index (0-100 points; higher scores indicate improved control). Baseline measurements taken pre-implantation

  Baseline and monthly evaluations over 12 months following epidural stimulator implantation

Secondary Outcomes (10)

• Balance Assessed by the Berg Balance Scale

  Baseline and monthly evaluations over 12 months post-implantation

• Walking Ability

  Baseline and monthly evaluations over 12 months post-implantation

• Spasticity Assessed by the Modified Ashworth Scale

  Baseline and monthly evaluations over 12 months post-implantation

• Pain Perception Assessed by the Douleur Neuropathique 4 Questions

  Baseline and monthly evaluations over 12 months post-implantation

• Pain Severity Assessed by the Brief Pain Inventory

  Baseline and monthly evaluations over 12 months post-implantation

Study Arms (1)

Epidural Electrical Stimulation + Intensive Rehabilitation Arm

EXPERIMENTAL

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.

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

Interventions

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

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.

Epidural Electrical Stimulation + Intensive Rehabilitation Arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Current use of electronic devices such as baclofen pumps or cardiac pacemakers.
• Presence of comorbidities that increase surgical risk (e.g., anticoagulation therapy, cardiopulmonary issues).
• Locomotor deformities or additional neurological disorders that may compromise evaluation.
• Significant dysautonomia or history of stroke or myocardial infarction associated with autonomic dysreflexia.
• MRI evidence of complete spinal cord transection, significant spinal atrophy, or significant syringomyelia.
• Uncontrolled pain, severe spasticity, or other conditions that hinder rehabilitation participation.
• Suspected abuse of opioids, alcohol, or other illegal substances.
• Estimated life expectancy of less than 2 years due to severe concomitant malignant or clinical conditions.
• Clinically significant mental health disorders.
• Botulinum toxin injections received in the past 6 months.
• Presence of voluntary movements during EMG testing in the lower extremities.
• Unhealed vertebral fractures.
• Presence of pressure ulcers.
• Active infection.
• Pregnancy.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Medtronic: collaborator

Study Sites (1)

University of São Paulo General Hospital

São Paulo, São Paulo, 05403010, Brazil

RECRUITING

Related Publications (12)

• Angeli CA, Edgerton VR, Gerasimenko YP, Harkema SJ. Altering spinal cord excitability enables voluntary movements after chronic complete paralysis in humans. Brain. 2014 May;137(Pt 5):1394-409. doi: 10.1093/brain/awu038. Epub 2014 Apr 8.

  PMID: 24713270 BACKGROUND

• Krogh K, Christensen P, Sabroe S, Laurberg S. Neurogenic bowel dysfunction score. Spinal Cord. 2006 Oct;44(10):625-31. doi: 10.1038/sj.sc.3101887. Epub 2005 Dec 13.

  PMID: 16344850 BACKGROUND

• The World Health Organization Quality of Life assessment (WHOQOL): position paper from the World Health Organization. Soc Sci Med. 1995 Nov;41(10):1403-9. doi: 10.1016/0277-9536(95)00112-k.

  PMID: 8560308 BACKGROUND

• Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A, Jafari-Schluep H, Lanteri-Minet M, Laurent B, Mick G, Serrie A, Valade D, Vicaut E. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain. 2005 Mar;114(1-2):29-36. doi: 10.1016/j.pain.2004.12.010. Epub 2005 Jan 26.

  PMID: 15733628 BACKGROUND

• Pollard CA. Preliminary validity study of the pain disability index. Percept Mot Skills. 1984 Dec;59(3):974. doi: 10.2466/pms.1984.59.3.974. No abstract available.

  PMID: 6240632 BACKGROUND

• Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.

  PMID: 8080219 BACKGROUND

• Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.

  PMID: 3809245 BACKGROUND

• Hallett M. NINDS myotatic reflex scale. Neurology. 1993 Dec;43(12):2723. doi: 10.1212/wnl.43.12.2723. No abstract available.

  PMID: 7802740 BACKGROUND

• Angeli C, Rejc E, Boakye M, Herrity A, Mesbah S, Hubscher C, Forrest G, Harkema S. Targeted Selection of Stimulation Parameters for Restoration of Motor and Autonomic Function in Individuals With Spinal Cord Injury. Neuromodulation. 2024 Jun;27(4):645-660. doi: 10.1016/j.neurom.2023.03.014. Epub 2023 May 4.

  PMID: 37140522 BACKGROUND

• Ditunno PL, Patrick M, Stineman M, Ditunno JF. Who wants to walk? Preferences for recovery after SCI: a longitudinal and cross-sectional study. Spinal Cord. 2008 Jul;46(7):500-6. doi: 10.1038/sj.sc.3102172. Epub 2008 Jan 22.

  PMID: 18209742 BACKGROUND

• GBD 2016 Traumatic Brain Injury and Spinal Cord Injury Collaborators. Global, regional, and national burden of traumatic brain injury and spinal cord injury, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 Jan;18(1):56-87. doi: 10.1016/S1474-4422(18)30415-0. Epub 2018 Nov 26.

  PMID: 30497965 BACKGROUND

• Mm P, Lg A, E G, C P, Mem B, Rjr F, Rm M, Af C, Jmd G, A A, B S, N M, K J, H C, Ga L. Time Course of Motor Improvement by Epidural Stimulation After Spinal Cord Injury: An Interim Analysis of a Phase II Trial. J Cent Nerv Syst Dis. 2025 Sep 22;17:11795735251379220. doi: 10.1177/11795735251379220. eCollection 2025.

  PMID: 40994969 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Guilherme Alves Lepski, MD, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matheus Moreli Porceban, MD, PhD student

CONTACT

+5511999157497; matheus.porceban@hc.fm.usp.br

Guilherme Alves Lepski, MD, PhD

CONTACT

+5511997858947; g.lepski@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 26, 2025
• Study Start: January 28, 2022
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): January 10, 2027
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The individual participant data (IPD) will be made available starting 6 months after the publication of the primary study results. The data will remain accessible for a period of 5 years from the start of availability. Researchers can request access to the de-identified IPD via a secure, password-protected repository, with all requests reviewed for compliance with privacy regulations and data sharing agreements.
• Access Criteria: The de-identified individual participant data (IPD) will be shared with qualified researchers, healthcare professionals, and institutions for legitimate scientific, educational, or health-related purposes. To request access, individuals must submit a formal application outlining their research objectives and intended analyses, including plans for data security and confidentiality. Requests will be reviewed by the study steering committee, which will assess the scientific merit of the proposed research, its alignment with the study's goals, and compliance with ethical standards. IPD will be shared through a secure, password-protected repository, with access granted only to those who meet all criteria.

Locations

BR (1)