Status:
UNKNOWN
Assessment of the Efficacy and Safety of EESS in Patients With Incomplete Spinal Cord Injuries
Lead Sponsor:
Hopital Foch
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-65 years
Phase:
NA
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, in...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 15 2023
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04496609
Start Date
July 12 2021
End Date
July 15 2023
Last Update
August 3 2022
Active Locations (2)
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1
Hôpital Raymond Poincaré
Garches, France, 92380
2
Hôpital Foch
Suresnes, France, 92150