Analgesic Effects of rTMS in Peripheral Neuropathic Pain

N/ACompletedNCT02010281

Assistance Publique - Hôpitaux de Paris152 enrolled

Overview

This study aims to evaluate the long term efficacy over 25 weeks of repeated sessions of magnetic transcranial stimulation of the motor cortex or prefrontal cortex on average pain intensity, quality of life, sleep, neuropathic symptoms, return to work, in patients with peripheral neuropathic pain. The medical device of study: transcranial magnetic stimulator (TMS).

The present multicenter parallel session randomized placebo controlled study (4 French centers) aims to evaluate the long term efficacy over 25 weeks of repeated sessions of magnetic transcranial stimulation of the motor cortex or prefrontal cortex on average pain intensity (primary outcome) and several secondary outcome measures (e.g. quality of life, sleep, neuropathic symptoms, return to work), in patients with peripheral neuropathic pain. The patients will be randomized to receive one of 3 treatment arms : rTMS of the motor cortex, rTMS of the prefrontal cortex, or placebo (sham stimulation) of the motor or prefrontal cortex. The study will be double blind, eg the patient and the investigator will not know the nature of treatment. the stimulation protocol will consist of an induction phasse of 5 daily sessions then a maintenance phase of several sessions : 3 sessions a week apart, 3 sessions a fortnight apart, and 3 sessions 3 weeks apart. The statistical analysis will be conducted in the intent to treat population and using a modified ITT analysis excluding all the patients with protocol violation (primary outcome). The per protocol population will also be assessed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

152

Conditions

Neuropathic Pain

Interventions

rTMS of prefrontal or motor cortexDEVICE

description:rTMS of the motor or prefrontal cortex (repetitive magnetic stimulation targeting the motor or prefrontal cortex) assisted with neuronavigation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Peripheral neuropathic pain (unilateral or bilateral) probable or defined according to the criteria proposed in 2008 (Treede et al 2008), 2. Diagnostic DN4 questionnaire score greater than or equal to 4/10 (Bouhassira et al 2005), 3. chronic pain, the average intensity is greater than or equal to 40/100 4. Daily or almost daily pain (at least 4 days out of 7) 5. This pain is present for more than 6 months 6. Patients over 18 and under 75 years old 7. Patients who signed informed consent, 8. Patients whose pain medication is stable for 15 days before inclusion, and will not need to be changed during the study period, 9. Patients who can be monitored during the study period (30 weeks) 10. Patients insured by a health insurance plan or entitled. Exclusion Criteria: 1. Previous treatment using rTMS, 2. Work Accident or dispute 3. rTMS Cons-indications (ECT treatment during the previous month, epilepsy and / or a history of epilepsy; history of head trauma, neurosurgical lesion, intracranial hypertension, metal clip, pacemaker, pregnant or lactating women) 4. Abuse of drugs or psychoactive substances (DSM IV) 5. Central neuropathic pain, 6. Neuropathic pain within the framework of a progressive disease (HIV, cancer, non-stabilized system disease) 7. Neuropathic pain very limited extent, of neuroma type 8. Current major depression or psychosis according to DSM IV criteria, 9. Intermittent pain, 10. Pain for less than six months, 11. Presence of another pain more severe than the one justifying the inclusion 12. Lack of proper filling of self-assessment of pain from baseline and randomization (at least 4 weekly pain scores 7 days) notebooks 13. Lack of stability of pain scores on two successive evaluations, defined as a change of more than 30% between the two assessments of the average pain on the short questionnaire about pain between the first two visits inclusion 14. Subject unable to understand informed consent, under guardianship, 15. Subject who refuses to stop or can not stop prohibited treatment during the study, 16. Patients participating in another research protocol involving a drug within 30 days before enrollment.

Locations (1)

Pain evaluation and treatement center, CHU Ambroise Paré

Boulogne-Billancourt, Hauts-de-Seine, France

Outcomes

Primary Outcomes

Change in average pain intensity from baseline to week 25

Change in average pain intensity from baseline to week 25, average pain intensity corresponds to average pain over the last 24 hours on the Brief Pain Inventory

Time frame: each visit for up to 25 weeks

Secondary Outcomes

change in minimal pain intensity over the last 24 hours from baseline to week 25

change in minimal pain over the last 24 hours on the Brief Pain inventory

Time frame: each visit for up 25 weeks

quality of life assessment

quality of life on the Eurogol questionnaire

Time frame: each visit up to 25 weeks

Proportion of responders to rTMS

Proportion of responders (patients whose pain is improved by at least 30% and 50% compared to their pain before treatment

Time frame: at the end of treatment (25 weeks)

Predictors of the response

Evaluation of predictors of response (nature of neuropathic symptoms, severity of anxiety or depressive symptoms, presence or absence of mechanical allodynia, or dramatization importance of catastrophism related to pain)

Time frame: Baseline

Safety evaluation

Collection of side effects at each session and between sessions of rTMS

Time frame: each follow up visit for up to 25 weeks

Onset of the analgesic effect of rTMS

Determine the onset of the analgesic effect based on patient pain diaries for up to 1 month

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.