NCT04936646

Study of RTMS Analgesic Effect in Chronic Neuropathic Pain,

Randomized Double-blind Study of RTMS Analgesic Effect in Chronic Neuropathic Pain. Comparison Between Three Groups: Motor Cortex Stimulation by the Classic Coil B65, Deeper Stimulation by the Coil B70 and Placebo Stimulation. Analysis of Long-term RTMS-induced Brain Changes Using FMRI.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the analgesic effectiveness of three modes of repetitive Transcranial Magnetic Stimulation (rTMS) in chronic neuropathic pain: * Classical rTMS stimulation * Deeper rTMS stimulation * Sham rTMS stimulation

Detailed description

Conduct of study: * Entry into the study: After informed consent, patients will be randomised. The physician responsible for conducting neurostimulation sessions will make the randomization via an interactive web response system (IWRS). Only this physician will have the knowledge of the group allocated to the patient. * Baseline : Patients, will record on a diary form, a daily Visual Numeric Scale(VNS) of Pain Intensity for 1 week. * Treatment sessions: after the baseline, sessions of neurostimulation will begin for seven weeks. * After the end of neurostimulation sessions, patients will be followed for 2 weeks. * Throughout their participation in the study, patients will plot on a diary form their daily VNS.

Conditions

• Chronic Neuropathic Pain

Interventions

Type	Name	Description
DEVICE	RepetitiveTranscranial Magnetic Stimulation (rTMS)	The rTMS protocol consist of one session per day for five days during the first week, then three sessions the second week and then one session the third week, followed by two monthly sessions.

Timeline

• Start date: 2021-07-16
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2021-06-23
• Last updated: 2024-12-06

Locations

1 site across 1 country: France