Analgesic Effects of rTMS in Peripheral Neuropathic Pain (TRANSNEP)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Neuropathic Pain

Treatments: Device: rTMS of prefrontal or motor cortex

Study type: Interventional

Funder types: Other

Identifiers

NCT02010281

AOM 120141 (Other Identifier)

P120126

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 152 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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152 participants in 3 patient groups, including a placebo group

rTMS of the motor cortex (Magventure)

Experimental group

Description:

experimental : rTMS of the motor cortex : repetitive magnetic stimulation targeting the motor cortex assisted by neuronavigation

Treatment:

Device: rTMS of prefrontal or motor cortex

rTMS placebo (magventure)

Placebo Comparator group

Description:

sham stimulation of the motor or prefrontal cortex with the placebo face of the device

Treatment:

Device: rTMS of prefrontal or motor cortex

rTMS prefrontal cortex (magventure)

Experimental group

Description:

Experimental : repetitive transcranial stimulation targeting the prefrontal cortex as indicated by neuronavigation

Treatment:

Device: rTMS of prefrontal or motor cortex