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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02506699
Other study ID # 13-025
Secondary ID
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


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
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