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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
45
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.
Centre de la douleur, CHU Grenoble Alpes
Grenoble, Isère, France
RECRUITINGEvolution of Pain.
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).
Time frame: Pain progression will be assessed from week 1 (before treatment) to week 7 (end of treatment)
Assesment of Potential Changes in Sensory-motor Cortical Maps Induced by rTMS
Comparison between the 3 groups of changes in sensory-motor cortical maps using Functional magnetic resonance imaging (FMRI).
Time frame: Day 60 from the beginning of rTMS treatment compared to baseline.
Rate of Responding Patients.
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.
Time frame: week 7 compared with baseline
Assessment of Overall Patient Improvement.
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).
Time frame: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline
Quality of Life Improvement.
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.
Time frame: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline
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Evolution of Anxiety and Depressive Traits.
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.
Time frame: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline
Evolution of Symptomatological Profiles of Neuropathic Pain.
Comparison between the 3 groups of symptomatological profiles of neuropathic pain using NPSI questionnaire (Neuropathic Pain Symptom Inventory).
Time frame: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline.
Sympathetic Autonomic System Injury and Small Fiber Neuropathy.
Comparison between the 3 groups of sympathetic autonomic system injury and small fiber neuropathy using the Sudoscan® device.
Time frame: Day 60 from the beginning of rTMS treatment compared to baseline.
Autonomous System Assessement.
Comparison between the 3 groups of changes in skin tension and conductance during fMRI examination.
Time frame: Day 60 from the beginning of rTMS treatment compared to baseline.
Evolution of the use of analgesic treatments.
Comparison between the 3 groups of the evolution of the use of analgesic treatments reported on the diary.
Time frame: From baseline to day 60.
Analgesic Response Analysis
Comparison between the 3 groups of the evolution of the weekly EVN average according to the clinical profile of patients
Time frame: From baseline to day 60.
Improvement of pain triggered by a stimulus (allodynia).
Comparison between the 3 groups of allodynia improvement.
Time frame: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline.