New Markers to Assess the Efficacity of Spinal Cord Stimulation for the Treatment of Chronic Lower Limb Pain (MOTIVE)
CompletedNCT04785001
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Assessment of New Physiological, Radiological and Activity Markers in Patients Treated by Spinal Cord Stimulation for Chronic Lower Limb Pain
- Conditions
- Spinal Cord Stimulation
- Sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Start date
- 2021-07-06
- Primary completion
- 2025-03-17
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04785001