Informations générales (source: ClinicalTrials.gov)
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
Observational
University Hospital, Caen (Voir sur ClinicalTrials)
juin 2013
septembre 2015
19 septembre 2025
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.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre d'évaluation et de traitement de la douleur (CETD) - 14000 - Caen - France | Emmanuelle TOUCHARD, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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