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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Pain
• Intervention / Treatment: Other: analgesic effect of rTMS

• Study Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • Recruiting
    • Centre d'évaluation et de traitement de la douleur (CETD)
    • Contact: Emmanuelle TOUCHARD, MD; Phone Number: 06 84 65 55 15; Email: touchard-e@chu-caen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chronic Neuropathic Pain

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
analgesic effect of rTMS; Observe the analgesic effect of rTMS, reference method of noninvasive stimulation of the motor cortex validated by data from the literature and current practice, after 5 separate sessions a week apart, patients with neuropathic pain chronic, refractory to first and second-line treatments proposed in a multidisciplinary center specializing in chronic pain Lower Normandy.	Other: analgesic effect of rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NPSI (Neuropathic Pain Symptom Inventory)	Analysis of analgesic efficacy: evolution of NPSI (Neuropathic Pain Symptom Inventory), validated scale in monitoring neuropathic pain, and VAS (visual analogue scale), to fill once a week over a period of 17 weeks, from one week before the first session of rTMS until three months after the last rTMS session.	baseline and after 17 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): September 1, 2015

Study Registration Dates

• First Submitted: July 22, 2015
• First Submitted That Met QC Criteria: July 22, 2015
• First Posted (Estimate): July 23, 2015

Study Record Updates

• Last Update Posted (Estimate): July 23, 2015
• Last Update Submitted That Met QC Criteria: July 22, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Chronic Pain; Neuralgia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics
• Other Study ID Numbers: 13-025