Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
ID06847295

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

Led by University of Sao Paulo General Hospital · Updated on 2025-02-26

10

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

U

University of Sao Paulo General Hospital

Lead Sponsor

M

Medtronic

Collaborating Sponsor

AI-Summary

What this Trial Is About

Spinal cord injury (SCI) causes significant long-term disability by impairing the ability to stand or walk, which greatly affects patients' quality of life. Researchers are studying epidural electrical stimulation (EES) combined with intensive rehabilitation to see if it can restore standing and walking in adults with chronic SCI who are unable to move their lower limbs. This prospective clinical study evaluates the safety and effectiveness of EES for improving motor function and reducing symptoms such as spasticity and pain. Participants will first complete a 3-month intensive rehabilitation program to maximize their motor function before receiving surgery to implant an epidural spinal cord stimulator. After a one-month recovery from surgery, the EES device will be activated while patients undergo 12 months of supervised physiotherapy sessions five times per week. The treatment aims to enhance motor recovery, balance, walking ability, and quality of life through tailored electrical stimulation and targeted exercises. Throughout the study, patients will be assessed monthly using clinical scales and surface electromyography (EMG) to measure muscle activity and motor improvements. Outcomes include gait recovery, balance, spasticity, pain levels, bladder and bowel function, mood, and overall quality of life. Video documentation and detailed neurophysiological data will be collected to monitor progress. The total participation period is approximately 16 months, including pre- and post-surgery rehabilitation and evaluation phases.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients aged 18 to 50 years
  • Stable spinal cord injury 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 informed consent
  • Willingness and ability to attend daily physiotherapy sessions
  • Clinically stable overall health as determined by investigators
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Pre-operative Rehabilitation

Duration - 3 months

Participants undergo an intensive rehabilitation program with five supervised physiotherapy sessions per week to maximize baseline motor function prior to surgery.

Five sessions per week

Surgery

Duration - 1 day

Participants receive surgical implantation of an epidural spinal cord stimulator including placement of a paddle lead and pulse generator.

1 visit (in-person, surgical procedure)

Post-operative Recovery

Duration - 1 month

Participants have a recovery period for wound healing and device programming before starting stimulation.

1 to 2 visits during recovery

Treatment

Duration - 12 months

Participants receive epidural electrical stimulation activated during five supervised physiotherapy sessions per week as part of a 12-month intensive rehabilitation program to promote motor recovery and improve function.

Five sessions per week

Follow-up

Duration - 12 months

Participants undergo regular monthly assessments including clinical scales, surface electromyography, and video documentation to monitor progress and adjust therapy.

Monthly visits

Trial Site Locations

Total: 1 location

1

University of São Paulo General Hospital

São Paulo, São Paulo, Brazil, 05403010

Actively Recruiting

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Research Team

M

Matheus Moreli Porceban, MD, PhD student

G

Guilherme Alves Lepski, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Altering spinal cord excitability enables voluntary movements after chronic complete paralysis in humans.

Claudia A Angeli, V Reggie Edgerton, Yury P Gerasimenko...

https://pubmed.ncbi.nlm.nih.gov/24713270

Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4).

Didier Bouhassira, Nadine Attal, Haiel Alchaar...

https://pubmed.ncbi.nlm.nih.gov/15733628

Targeted Selection of Stimulation Parameters for Restoration of Motor and Autonomic Function in Individuals With Spinal Cord Injury.

Claudia Angeli, Enrico Rejc, Maxwell Boakye...

https://pubmed.ncbi.nlm.nih.gov/37140522