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

Sponsor

University Hospital, Caen (Other)

Overall Status

Unknown status

CT.gov ID

NCT02506699

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Other: analgesic effect of rTMS

Study Design

Study Type:

Observational

Anticipated Enrollment :

15 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 Start Date :

Jun 1, 2013

Anticipated Primary Completion Date :

Sep 1, 2015

Anticipated Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

NPSI (Neuropathic Pain Symptom Inventory) [baseline and after 17 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient 18 to 70 years with:

Pain lasting for more than six months;
Monitoring in CETD in Normandy;
Having had a bio-psycho-social assessment and have been the subject of a multidisciplinary discussions recorded in the medical record;
Presenting unilateral neuropathic pain, central or peripheral origin:

may affect the face,
upper limb,
or hémicorps but including at least the upper limb;

With neuropathic pain screening test positive (≥ DN4 4/10);
etiology objectified by further examinations (MRI, scanner, or EMG, PES MEP);
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:

Brain implanted ferromagnetic material,
Implanted neurostimulator (cortical and deep brain, spinal cord)
Cochlear Implants
Active epilepsy (seizures despite existence of a current treatment)
Pacemakers
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre d'évaluation et de traitement de la douleur (CETD)	Caen		France	14000

Sponsors and Collaborators

University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Caen

ClinicalTrials.gov Identifier:

NCT02506699

Other Study ID Numbers:

13-025

First Posted:

Jul 23, 2015

Last Update Posted:

Jul 23, 2015

Last Verified:

Jul 1, 2015

Additional relevant MeSH terms:

Neuralgia

Chronic Pain

Analgesics

Study Results

No Results Posted as of Jul 23, 2015