Clinical trial NCT02506699: Observational Study of the Analgesic Effect of Treatment With rTMS in Patients With Chronic Neuropathic Pain
Official title: Observational Study of the Analgesic Effect of Treatment With rTMS in Patients Suffering From Chronic Neuropathic Pain Refractory to Conventional Treatment and Monitored and Evaluated in Consultation Multidisciplinary Chronic Pain in Lower Normandy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pain
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-07-23
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic Neuropathic Pain

Brief 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 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 a multidisciplinary 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;
  5. With neuropathic pain screening test positive (≥ DN4 4/10);
  6. etiology objectified by further examinations (MRI, scanner, or EMG, PES MEP);
  7. Resistant to usual treatments: less than 50% improvement compared to the initial pain (EN or EVA) in patients who received an effective dose for treatment of first and a second intention.

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 childbearing age
* Psychiatric illness decompensated
* Cancer pain and post-chemotherapy
* severe cognitive disorders

Primary outcomes:
measure: NPSI (Neuropathic Pain Symptom Inventory)
timeFrame: baseline and after 17 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre d'évaluation et de traitement de la douleur (CETD)
Study officials:
References: