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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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
• Устройство Automated rehabilitation / Stimulation and automated rehabilitation
  Automated rehabilitation for 40 working days, then washout during 30 days, then automated rehabilitation for 40 working days

Первичные конечные точки

• Assessment of number of patients able to move over a distance of 5 metres [Срок оценки: through study completion]

Вторичные конечные точки (12)

• Percentage of patients capable of moving at the end of treatment [Срок оценки: 1 hour]
• Assessment of vesico-sphincter function [Срок оценки: 1 hour]
• Assessment of the genito-sexual function [Срок оценки: 30 minutes]
• Assessment of the excitability of the spinal neuronal circuits [Срок оценки: 1 hour]
• Assessment of the kinetics of action of the induced effects [Срок оценки: 1 hour]
• Assessment of capability to move over a distance of 5 metres at the end of washout period for treatment combining EESS and rehabilitation program [Срок оценки: throughout the study]
• Assessment of capability to move over a distance of 5 metres at the end of washout period for rehabilitation program [Срок оценки: 30 minutes]
• Assessment of capability to move over a distance of 5 metres after 6 months of treatment [Срок оценки: Month 6]
• Assessment of vesico-sphincter function at the end of washout period for treatment combining EESS and rehabilitation program [Срок оценки: 1 hour]
• Assessment of vesico-sphincter function at the end of washout period for rehabilitation program [Срок оценки: 1 hour]
• Assessment of vesico-sphincter function after 6 months of treatment [Срок оценки: Month 6]
• Assessment of the genito-sexual function at the end of washout period for treatment combining EESS and rehabilitation program [Срок оценки: 30 minutes]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 2 центра

• Hôpital Raymond Poincaré — Garches
• Hôpital Foch — Suresnes

Идентификаторы

NCT: NCT04496609 · 2016/50

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗