New Markers to Assess the Efficacity of Spinal Cord Stimulation for the Treatment of Chronic Lower Limb Pain (MOTIVE)

NCT04785001 | Completed

• 1 other identifier: HBD_2020_23
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Stimulation

Keywords

SCS (spinal cord stimulation); HRV (Heart Rate Variability); MRIf (anatomical and functional magnetic resonance imaging)

Outcome Measures

Primary Outcomes (1)

• Evaluation of Heart Rate Variability (HRV) in chronic lower leg pain patients treated with spinal cord stimulation.

  Heart rate variability will be evaluated before (baseline) and 3 months after surgery. HRV parameters, including time domain and frequency domain, will be obtained from 24-hour Holter monitoring. Two time-domain variables will be used to determine HRV : the standard deviation of intervals of all normal beat (SDNN) and the root mean square of the difference of successive R-R intervals (rMSSD).

  3 months after implantation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients followed for drug-resistant neuropathic pain in the lower limbs and requiring implantation for SCS according to HAS criteria will be eligible.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologie Adolphe de Rothschild

Paris, paris, 75019, France

Location

Study Officials

• Hayat BELAID, Dr

  Fondation Ophtalmologie Adolphe Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: March 5, 2021
• Study Start: July 6, 2021
• Primary Completion: March 17, 2025
• Study Completion: May 27, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

FR (1)