New Markers to Assess the Efficacity of Spinal Cord Stimulation for the Treatment of Chronic Lowe… (NCT04785001) | Clinical Trial Compass
CompletedNot Applicable
New Markers to Assess the Efficacity of Spinal Cord Stimulation for the Treatment of Chronic Lower Limb Pain (MOTIVE)
France25 participantsStarted 2021-07-06
Plain-language summary
By combining the usual care of patients eligible for spinal cord stimulation (SME) with measurements of the HRV index (Heart Rate Variability), objective measurements of activity (number of steps, quality of sleep) and measurements of connectivity obtained by anatomical and functional magnetic resonance imaging (fMRI), the collection of preliminary data necessary for the analysis of markers correlated with the efficiency of stimulation will be possible. Ultimately, these markers could be used to optimize the perioperative management of these patients.
Who can participate
Age range
18 Years – 75 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:
* Lower limb pain included in the inclusion criteria for spinal cord stimulation according to HAS recommendations: neuropathic, lumbar radicular sequelae after spinal surgery, complex regional pain syndrome (CRPS)
* Chronic pain that has been present for at least 6 months
* Rebellious pain resistant to drug and non-drug treatments well conducted;
* Functional impact defined by a score\> 20% on the Oswestry scale;
* Patient affiliated or beneficiary of a social security scheme;
* Patient who consented to participate in the study.
Exclusion Criteria:
* Presence of a surgical contraindication to the implantation of material (chronic infection, long-term anticoagulant treatment that cannot be interrupted, contraindication to anesthesia);
* Addiction (according to DSM IV);
* Major depressive syndrome despite appropriate treatment and / or psychotic symptoms (according to DSM IV);
* Unbalanced psychiatric disorder;
* Intermittent pain or present for less than 6 months;
* Diffuse painful syndrome;
* Progressive disease, associated inflammatory rheumatic pathology, and any other disabling pathology limiting physical activity (advanced articular osteoarthritis);
* Absolute contraindication to MRI (e.g. pace-maker, implantable stimulator, intra-orbital metallic foreign body);
* Language barrier or cognitive disorders preventing understanding of the research protocol;
* Person benefiting from a legal protection measure;
* Pregnant or breastfeeding woman.
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
1
Evaluation of Heart Rate Variability (HRV) in chronic lower leg pain patients treated with spinal cord stimulation.
Timeframe: 3 months after implantation
Trial details
NCT IDNCT04785001
SponsorFondation Ophtalmologique Adolphe de Rothschild