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Tests treatment safety and results for Spinal Cord Injuries
Official title Assessment of the Efficacy and Safety of EESS in Patients With Incomplete Spinal Cord Injuries
ClinicalTrials.gov ID: NCT04496609
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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
You likely can't join 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)
See the full eligibility 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
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Garches, France
- Suresnes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Garches, France; Suresnes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.