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

Chronic Pain Clinical Trial

— rTMSDOULNEURO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02506699
• Other study ID #: 13-025
• Status: Recruiting
• Phase: N/A
• First received: July 22, 2015
• Last updated: July 22, 2015
• Start date: June 2013
• Est. completion date: September 2015

Study information

• Verified date: July 2015
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Pain
• Neuralgia

Intervention

Other:
• analgesic effect of rTMS

Locations

Country	Name	City	State
France	Centre d'évaluation et de traitement de la douleur (CETD)	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes