Epidural electrical stimulation to help patients with chronic paralysis stand and walk again

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study evaluates the efficacy and safety of epidural electrical stimulation (EES) in patients with chronic spinal cord injuries who have lost the ability to stand or walk. The study involves the surgical implantation of an epidural spinal cord stimulator, followed by a 12-month intensive rehabilitation program. Primary outcomes include assessing gait recovery and secondary outcomes focus on improvements in balance, walking capacity, spasticity reduction, and overall quality of life. The study aims to leverage neuromodulation to enhance neuroplasticity and restore motor function in affected individuals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• University of São Paulo General Hospital
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Guilherme Alves Lepski, MD, PhD — University of Sao Paulo
• Study coordinator: Matheus Moreli Porceban, MD, PhD student
• Email: matheus.porceban@hc.fm.usp.br
• Phone: +5511999157497

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.