Assessment of the Efficacy and Safety of EESS in Patients With Incomplete Spinal Cord Injuries
Eligible age
18–65 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
Neurological disability caused by traumatic lesions of the spinal cord is a significant challenge for medicine and society. These lesions, leading to sublesional central nervous system dysfunction, include sensorimotor, vesico-sphincter and genito-sexual disorders. To date, there is no treatment that enables spinal cord function to be restored. Preclinical studies have been able to demonstrate the recovery of locomotor activity with a combination of locomotor training, pharmacological intervention and epidural electrical stimulation of the lumbosacral spinal cord (EESS) in adult rats with spinal cord transection. An American team have recently been able to show that EESS, combined with locomotor training, caused neurological improvement in four paraplegic patients, with electromyographic muscular activation patterns similar to those observed during walking. In fact, these authors also showed an improvement, under stimulation, of the VS and GS functions, but with no detailed documentation. Starting with a conceptual and preclinical rationale, and with proof of clinical concept demonstrated in several reported cases, we propose a clinical trial with an original cross-over design to validate the hypothesis that EESS combined with training in patients with incomplete spinal cord injuries would, with a good tolerance profile, allow motor, vesico-sphincter (VS) and genito-sexual (GS) disorders to be restored in patients with incomplete spinal cord injuries.
Sponsor: Hopital Foch
You may qualify if…
- ✓ Aged between 18 and 65 years inclusive
- ✓ Male or female
- ✓ Incomplete ASIA B or C spinal cord lesion with level of lesion located above T10 (sensation preserved below level of lesion)
- ✓ Absence of significant motor deficit of the upper limbs or recovered motor deficit (muscular score ≥ 4/5)
- ✓ Patient with spinal cord injury at least 2 years old and considered stable not walking
- ✓ Spinal cord lesion determined by spinal cord MRI (intramedullary hypersignal)
- ✓ Patient who can benefit from an iterative rehabilitation programme
- ✓ Patient with stable health condition with no cardiopulmonary disease
You may not qualify if…
- ✕ Significant cerebral lesion on a previous cerebral MRI
- ✕ Psychiatric or cognitive disorder history (known or detected during the consultation with the psychologist)
- ✕ Protected adult patients
- ✕ Pregnant (determined by a negative pregnancy test) or breastfeeding women
- ✕ Respiratory failure (vital capacity \< 50%) (surgery in prone position)
- ✕ Repeated urinary infections (≥3 per year)
- ✕ Planned absence that may hinder participation in the study (travelling abroad, relocation, imminent moving)
- ✕ Patients with spasms (PENN scale \> 2)
Source: ClinicalTrials.gov · NCT04496609 · last updated 2026-06-11