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

NCT ID: NCT04496609

Last Updated: 2022-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-12
• Study Completion Date: 2023-07-15

Brief 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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stimulation-automated rehabilitation/automated rehabilitation

• Stimulation and automated rehabilitation (2 sessions of 45 minutes per day) for 40 working days
• Washout 30 days
• Automated rehabilitation (2 sessions of 45 minutes per day) for 40 working days

Group Type: EXPERIMENTAL

Stimulation and automated rehabilitation / automated rehabilitation

Intervention Type: DEVICE

Stimulation and automated rehabilitation for 40 working days, then washout during 30 days, then automated rehabilitation for 40 working days

Automated rehabilitation/Stimulation-automated rehabilitation

• Automated rehabilitation (2 sessions of 45 minutes per day) for 40 working days
• Washout 30 days
• Stimulation and automated rehabilitation (2 sessions of 45 minutes per day) for 40 working days

Group Type: EXPERIMENTAL

Automated rehabilitation / Stimulation and automated rehabilitation

Intervention Type: DEVICE

Automated rehabilitation for 40 working days, then washout during 30 days, then automated rehabilitation for 40 working days

Interventions

Stimulation and automated rehabilitation / automated rehabilitation

Stimulation and automated rehabilitation for 40 working days, then washout during 30 days, then automated rehabilitation for 40 working days

Intervention Type: DEVICE

Automated rehabilitation / Stimulation and automated rehabilitation

Automated rehabilitation for 40 working days, then washout during 30 days, then automated rehabilitation for 40 working days

Intervention Type: DEVICE

Eligibility Criteria

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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopital Foch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Béchir Jarraya, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Foch

Locations

Hôpital Raymond Poincaré

Garches, , France

Site Status: RECRUITING

Hôpital Foch

Suresnes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Elisabeth Hulier-Ammar

Role: CONTACT

drci-promotion@hopital-foch.com

+33 1 46 25 11 75

Facility Contacts

Nicolas Roche, MD

Role: primary

nicolas.roche@aphp.fr

+33 1 47 10 79 00

Béchir Jarraya, MD

Role: primary

b.jarraya@hopital-foch.com

+33 1 46 25 29 66

Other Identifiers

2016/50

Identifier Type: -

Identifier Source: org_study_id