Study of RTMS Analgesic Effect in Chronic Neuropathic Pain,
- Conditions
- Chronic Neuropathic Pain
- Interventions
- Device: RepetitiveTranscranial Magnetic Stimulation (rTMS)
- Registration Number
- NCT04936646
- Lead Sponsor
- University Hospital, Grenoble
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
- Patient's written consent
- Affiliated with social security system
- Male or female, suffering for more than a year from unilateral refractory neuropathic pain: hemi-body, upper limb, lower limb and facial chronic pain.
- Patient whose analgesic treatment, is stable for at least 1 month.
- Patient not responding to conventional treatments
- Prescreening EVN >3
- History of drug addiction, epilepsy, cranial trauma
- History of psychiatric disorder
- Patients previously treated with rTMS
- Patient with intracranial ferromagnetic material or implanted stimulator
- New treatment for less than one month
- Pregnant or Breastfeeding woman
- Patient who does not understand the study protocol
- Persons who are protected under the act.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Classic rTMS Stimulation using the B65 Coil RepetitiveTranscranial Magnetic Stimulation (rTMS) - Deeper rTMS Stimulation using the B70 Coil RepetitiveTranscranial Magnetic Stimulation (rTMS) - control group with a sham stimulation using a sham coil RepetitiveTranscranial Magnetic Stimulation (rTMS) -
- Primary Outcome Measures
Name Time Method Evolution of Pain. Pain progression will be assessed from week 1 (before treatment) to week 7 (end of treatment) Comparison between the 3 groups of the evolution of the weekly value of the Visual Numeric Scale (VNS): The patient will raise his pain level on a follow-up diary each day. The VNS average will be calculated for each week. The NSV is a 10-point scale, ranging from 0 (worse) to 10 (better).
- Secondary Outcome Measures
Name Time Method Improvement of pain triggered by a stimulus (allodynia). Day 30 and day 60 from the beginning of rTMS treatment compared to baseline. Comparison between the 3 groups of allodynia improvement.
Assesment of Potential Changes in Sensory-motor Cortical Maps Induced by rTMS Day 60 from the beginning of rTMS treatment compared to baseline. Comparison between the 3 groups of changes in sensory-motor cortical maps using Functional magnetic resonance imaging (FMRI).
Assessment of Overall Patient Improvement. Day 30 and day 60 from the beginning of rTMS treatment compared to baseline Comparison between the 3 groups of the overall patient improvement using the Clinical Global Impression of Change scale (CGI).The CGI is a 7-point scale, ranging from 1 (better) to 7 (worse).
Quality of Life Improvement. Day 30 and day 60 from the beginning of rTMS treatment compared to baseline Comparison between the 3 groups of the improvement of quality of life using the SF12 (Short Form 12) questionnaire.SF12 includes a mental and social score ranging from 5.89 to 71.97 and a physical score ranging from 9.95 to 70. a high score indicates a better quality of life.
Evolution of Anxiety and Depressive Traits. Day 30 and day 60 from the beginning of rTMS treatment compared to baseline Comparison between the 3 groups of the improvement of anxiety and depressive traits using the HADS questionnaire (Hospital Anxiety and Depression Scale).the HADS score varies between 0 and 42. zero corresponding to the best score.
Evolution of the use of analgesic treatments. From baseline to day 60. Comparison between the 3 groups of the evolution of the use of analgesic treatments reported on the diary.
Rate of Responding Patients. week 7 compared with baseline Comparison between the 3 groups of the rate of responding patients. Responding patients is defined by a 30% reduction in pain intensity assessed with VNS.
Analgesic Response Analysis From baseline to day 60. Comparison between the 3 groups of the evolution of the weekly EVN average according to the clinical profile of patients
Evolution of Symptomatological Profiles of Neuropathic Pain. Day 30 and day 60 from the beginning of rTMS treatment compared to baseline. Comparison between the 3 groups of symptomatological profiles of neuropathic pain using NPSI questionnaire (Neuropathic Pain Symptom Inventory).
Sympathetic Autonomic System Injury and Small Fiber Neuropathy. Day 60 from the beginning of rTMS treatment compared to baseline. Comparison between the 3 groups of sympathetic autonomic system injury and small fiber neuropathy using the Sudoscan® device.
Autonomous System Assessement. Day 60 from the beginning of rTMS treatment compared to baseline. Comparison between the 3 groups of changes in skin tension and conductance during fMRI examination.
Trial Locations
- Locations (1)
Centre de la douleur, CHU Grenoble Alpes
🇫🇷Grenoble, Isère, France