EESS and automated rehabilitation for incomplete spinal cord injuries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial is exploring whether epidural electrical stimulation of the lumbosacral spinal cord, when paired with automated rehabilitation, can improve neurological function in adults with incomplete spinal cord injuries above T10. The study builds on preclinical and early human work suggesting motor activation and some recovery of functions, including bladder and sexual function, with stimulation plus training. Participants undergo an iterative rehabilitation program alongside stimulation, with safety and functional outcomes monitored over time. The trial is conducted at two French centers and is sponsored by Hopital Foch.

Why it matters

Who can join: the full rules

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)

Where it's running

• Hôpital Raymond Poincaré
  Garches, France Recruiting
• Hôpital Foch
  Suresnes, France Recruiting

Study contacts

• Principal investigator: Béchir Jarraya, MD — Hôpital Foch
• Study coordinator: Béchir Jarraya, MD
• Email: b.jarraya@hopital-foch.com
• Phone: 01 46 25 29 66

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.