RecruitingNot Applicable

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

France14 participantsStarted 2021-07-12

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 breastfeedin…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment of number of patients able to move over a distance of 5 metres

Timeframe: through study completion

Trial details

NCT IDNCT04496609

SponsorHopital Foch

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07-12

Contact for this trial

Béchir Jarraya, MD

01 46 25 29 66 b.jarraya@hopital-foch.com

View on ClinicalTrials.gov More Spinal Cord Injuries trials