Assessment of the Efficacy and Safety of EESS in Patients With Incomplete Spinal Cord Injuries

Phase

N/A

Condition

Spinal Cord Injuries

Treatment

N/A

Clinical Study ID

NCT04496609

2016/50

Ages 18-65
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 factorssignificant 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

Exclusion

Exclusion Criteria:

Significant cerebral lesion on a previous cerebral MRI
Psychiatric or cognitive disorder history (known or detected during the consultationwith 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 notMRI-compatible, iv) cochlear implant, v) metal foreign body, etc.)
Patients presenting with a contraindication to MEPs being carried out (notably wearingof ferromagnetic material, heart stimulator)
Patients on oral anticoagulants
Patients with botulinic toxin injection
Patients with bedsore
Undernourished patients (BMI < 19)

Study Design

July 12, 2021

July 15, 2023

Connect with a study center

Hôpital Raymond Poincaré
Garches, 92380
France
Active - Recruiting
Hôpital Foch
Suresnes, 92150
France
Active - Recruiting

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