Repetitive Transcranial Magnetic Stimulation in Central Neuropathic Pain

Centre Hospitalier Universitaire de Saint Etienne

Status

Completed

Conditions

Neuropathic Pain

Treatments

Device: active rTMS then sham rTMS

Device: sham rTMS then active rTMS

Study type

Interventional

Funder types

Other

Identifiers

NCT02386969

2015-A00065-44 (Other Identifier)

1408207

Details and patient eligibility

About

The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several years. The aim of the study is to assess, in a rigorous scientific protocol, analgesic effect of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic painful subjects. The crossover study is randomized, double blinded and controlled (sham rTMS) and it includes a large homogeneous population suffering of central neuropathic pain.

Full description

The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several years. The latest meta-analysis showed that rTMS has not prove its scientific efficacy. It could be explained by several reasons: poor methodologic quality, stimulations parameters, technologic hardware, ... The aim of the study is to assess, in a rigorous scientific protocol, analgesic effect of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic painful subjects. The crossover study is randomized, double blinded and controlled (sham rTMS) and it includes a large homogeneous population suffering of central neuropathic pain. The stimulated region is the primary motor cortex with high frequency (20Hz). This study has two periods (real and sham) of 12 weeks with four sessions of stimulation per period and 8 weeks of washout between the two.

Enrollment

50 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Central neuropathic pain
Chronic pain with an average pain intensity is greater than or equal to 40/100
Pain presents a daily or almost daily (at least 4 days out of 7)
Pain presents for more than 6 months
Patients who signed informed consent,
Patients whose pain medication is stable for 15 days before to inclusion, and will not need to be modified for the duration of the study,
Patients can be monitored for the duration of the study (29 weeks)
Patients affiliated to a health insurance plan or entitled,
Patients with a cerebral MRI T1.

Exclusion criteria

Labor dispute or Accident,
Contraindication to rTMS (treatment with electroconvulsive therapy during the previous month, epilepsy and / or a history of epilepsy, history of head trauma, neurosurgical injury; intracranial hypertension metal clip; pacemaker pregnant or lactating women)
Abuse of drugs or psychoactive substances
Peripheral Neuropathic Pain,
Neuropathic pain within the framework of a progressive disease (HIV, cancer, non-stabilized system disease)
Intermittent pain,
Pain in less than 6 months,
Presence of other pain more severe than that justify inclusion,
Lack of stability pain scores on two successive evaluations, defined as a change of more than 30% between the two assessments of the average pain between the first two visits (inclusion and first session)
Patients unable to understand informed consent, under guardianship,
Patients refusing to stop or can not stop the prohibited treatment during the study,
Patients participating in another research protocol involving a drug within 30 days before inclusion.