Assessment of the Efficacy and Safety of EESS in Patients With Incomplete Spinal Cord Injuries
Parastim
1 other identifier
interventional
14
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2021
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2020
CompletedFirst Posted
Study publicly available on registry
August 3, 2020
CompletedStudy Start
First participant enrolled
July 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2023
CompletedAugust 3, 2022
August 1, 2022
2 years
July 20, 2020
August 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of number of patients able to move over a distance of 5 metres
Determined by a capability to move over a distance of 5 metres with or without technical aid, with the option of stopping on the way
through study completion
Secondary Outcomes (20)
Percentage of patients capable of moving at the end of treatment
1 hour
Assessment of vesico-sphincter function
1 hour
Assessment of the genito-sexual function
30 minutes
Assessment of the excitability of the spinal neuronal circuits
1 hour
Assessment of the kinetics of action of the induced effects
1 hour
- +15 more secondary outcomes
Study Arms (2)
Stimulation-automated rehabilitation/automated rehabilitation
EXPERIMENTAL* 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
Automated rehabilitation/Stimulation-automated rehabilitation
EXPERIMENTAL* 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
Interventions
Stimulation and automated rehabilitation for 40 working days, then washout during 30 days, then automated rehabilitation for 40 working days
Automated rehabilitation for 40 working days, then washout during 30 days, then automated rehabilitation for 40 working days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hopital Fochlead
Study Sites (2)
Hôpital Raymond Poincaré
Garches, 92380, France
Hôpital Foch
Suresnes, 92150, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Béchir Jarraya, MD
Hôpital Foch
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2020
First Posted
August 3, 2020
Study Start
July 12, 2021
Primary Completion
July 15, 2023
Study Completion
July 15, 2023
Last Updated
August 3, 2022
Record last verified: 2022-08