Observational Study of the Analgesic Effect of Treatment With rTMS in Patients With Chronic Neuropathic Pain

Last updated: July 22, 2015
Sponsor: University Hospital, Caen
Overall Status: Trial Status Unknown

Phase

N/A

Condition

Chronic Pain

Pain (Pediatric)

Pain

Treatment

N/A

Clinical Study ID

NCT02506699
13-025
  • Ages 18-70
  • All Genders

Study Summary

For ten years, rTMS, repetitive transcranial magnetic stimulation of the motor cortex, has found its place in the treatment of drug-resistant neuropathic pain. Patients relieved by some sessions may thereafter receive a chronic invasive stimulation via electrodes implanted through a neurosurgical procedure. This is common practice at the University Hospital of Caen and in different CHU with the proper equipment rTMS. It seems permissible to provide in our center only a non-invasive technique for patients challenged with brain surgery, since according to the various meta-analyzes the analgesic efficacy of rTMS seems to be correlated to the repetition of sessions.

Assessment centers and the treatment of pain allow a multidimensional assessment, bio-psycho-social of patients in order to optimize their management and experience efficiently analgesics first- and second-line.

We propose a study evaluating the analgesic efficacy of rTMS, in relevant stimulation parameters reproduced according to a literature review, during 3 months after 5 active sessions separated by one week apart, in 15 patients with neuropathic pain chronic refractory to treatment of first and second line, followed by multidisciplinary center specializing in chronic pain Lower Normandy. The quality of life will also be assessed by validated scales, and the results will be compared to the literature data.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient 18 to 70 years with:

  1. Pain lasting for more than six months;

  2. Monitoring in CETD in Normandy;

  3. Having had a bio-psycho-social assessment and have been the subject of amultidisciplinary discussions recorded in the medical record;

  4. Presenting unilateral neuropathic pain, central or peripheral origin:

  • may affect the face,

  • upper limb,

  • or hémicorps but including at least the upper limb;

  1. With neuropathic pain screening test positive (≥ DN4 4/10);

  2. etiology objectified by further examinations (MRI, scanner, or EMG, PES MEP);

  3. Resistant to usual treatments: less than 50% improvement compared to the initialpain (EN or EVA) in patients who received an effective dose for treatment offirst and a second intention.

Exclusion

Exclusion Criteria:

  • Contraindications of rTMS:

  1. Brain implanted ferromagnetic material,

  2. Implanted neurostimulator (cortical and deep brain, spinal cord)

  3. Cochlear Implants

  4. Active epilepsy (seizures despite existence of a current treatment)

  5. Pacemakers

  6. Hearing loss or current taking ototoxic drugs (aminoglycosides, cisplatin)

  • Pregnancy, breastfeeding, lack of effective contraception for patients of childbearingage

  • Psychiatric illness decompensated

  • Cancer pain and post-chemotherapy

  • severe cognitive disorders

Study Design

Total Participants: 15
Study Start date:
June 01, 2013
Estimated Completion Date:
September 30, 2015

Connect with a study center

  • Centre d'évaluation et de traitement de la douleur (CETD)

    Caen, 14000
    France

    Active - Recruiting

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