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

NCT ID: NCT02506699

Last Updated: 2015-07-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-09-30

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.

Conditions

Chronic Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

analgesic effect of rTMS

Intervention Type: OTHER

Interventions

analgesic effect of rTMS

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Caen, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Emmanuelle TOUCHARD, MD

Role: primary

touchard-e@chu-caen.fr

06 84 65 55 15

Other Identifiers

13-025

Identifier Type: -

Identifier Source: org_study_id