Informations générales (source: ClinicalTrials.gov)
Assessment of the Efficacy and Safety of Epidural Electrical Stimulation of the Lumbosacral Spinal Cord in the Symptomatic Treatment of Motor, Vesico-sphincter and Genito-sexual Disorders in Patients With Incomplete Spinal Cord Injuries (Parastim)
Interventional
N/A
Hopital Foch (Voir sur ClinicalTrials)
juillet 2021
juillet 2023
26 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | BECHIR JARRAYA | 05/05/2025 07:12:07 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hôpital Raymond Poincaré - 92380 - Garches - France | Nicolas Roche, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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
- Patient with orthopaedic condition compatible with verticality and walking
- Persistence of adductor reflexes up to L2
- Patient with no current neuromodulation implant: spinal cord neurostimulator, brain,
peripheral nerve or intrathecal treatment
- Patient with no coagulopathy, cardiac risk factors or other medical risk factors
significant for surgery
- Local anatomical conditions compatible with implantation of the epidural electrode
(determined by MRI of the spinal cord)
- Person who benefits from or is entitled to a social security scheme
- Having provided signed informed consent
- 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
- Patient with orthopaedic condition compatible with verticality and walking
- Persistence of adductor reflexes up to L2
- Patient with no current neuromodulation implant: spinal cord neurostimulator, brain,
peripheral nerve or intrathecal treatment
- Patient with no coagulopathy, cardiac risk factors or other medical risk factors
significant for surgery
- Local anatomical conditions compatible with implantation of the epidural electrode
(determined by MRI of the spinal cord)
- Person who benefits from or is entitled to a social security scheme
- Having provided signed informed consent
- 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)
- Cauda equina syndrome
- Patients presenting with a contraindication to an MRI being carried out: i)
pacemaker, ii) non-MRI-compatible heart valve, iii) clips, stents, coils, etc. that
are not MRI-compatible, iv) cochlear implant, v) metal foreign body, etc.)
- Patients presenting with a contraindication to MEPs being carried out (notably
wearing of ferromagnetic material, heart stimulator)
- Patients on oral anticoagulants
- Patients with botulinic toxin injection
- Patients with bedsore
- Undernourished patients (BMI < 19)