Neuropathic Chronic Pain Clinical Trial
— DOLORISOfficial title:
Evaluation of Repetitive Magnetic Stimulation Versus Direct Current Stimulation, in Chronic Neuropathic and Drug-resistant Pain Treatment
Prevalence of neuropathic pain raise to 6.9 % in the general population and can reach more
than 58 % for patients that carry a lesion of the spinal cord. This pathological condition
stays a major health problem, particularly as the efficacity of available treatments is
currently limited. Only 30 to 40% of patients are relieved of more than 50% of their pain by
a pharmacological approach.
In case of failure, drug treatments or in addition of these ones, stimulation of the motor
cortex is a therapeutic path proposed by Tsubokawa since the beginning of 1990s, but that
found its place for neuropathic drug-resistant pain management only since a decade.
Neurophysiologic mechanisms of the analgesic efficacity of the motor cortex stimulation are
still little understood. This stimulation can be realised in a chronic and invasive way with
implanted electrodes. This process allow a lasting relief for about half of operated
persons, without the possibility to identify clinical selection criterion reliable for
potentially responding patients for this technique.
Recently, two electrophysiological non invasive techniques have been developed, allowing to
get an analgesic stimulation of the motor cortex: the repetitive transcranial magnetic
stimulation (rTMS) and the direct current transcranial magnetic stimulation (tDCS).
The main goal of this study is to compare the importance of analgesic effect of tDCS in
chronic drug-resistant neurophysiologic pains to the one get thanks to a reference method of
stimulation non invasive of the motor cortex, the rTMS whose analgesic effect is already
validated by data of the literature.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | December 2018 |
| Est. primary completion date | December 2018 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Persons affiliated to national social security. - Patients that have given their signed free consent. - Patients from 18 to 80 years, men or women, carriers of a chronic neuropathic pain (since more than a year ; EVN > 2during week S0) drug resistant, unilateral, involving at least the superior member and/or hemi-face, whose analgesic treatment is stable from at least one month. - Patients whose drug resistance conduce their referent Algologist (specialist in pain medicine) to study the possibility to propose them alternative therapeutic solutions nonpharmacological and to start a pre-surgical examination. Exclusion Criteria: - History of drug addiction, migraine, epilepsy. - Presence of ferromagnetic intracranial equipment or a stimulating implanted (pace-maker, stimulation of basal ganglia, vagus nerve stimulator). - Introduction of a new analgesic treatment since at least a month. - Pregnant, parturient or breastfeeding women. The absence of effective contraception during all the study for patients of childbearing age. - Persons deprived of liberty by judicial or administrative decision, person under legal protection. - Counter-argument to MRI. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| France | UniversityHospitalGrenoble | La Tronche |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Grenoble |
France,
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* Note: There are 36 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | High-frequency | rTMS session : repetitive transcranial magnetic stimulation. MRI |
Half an hour | No |
| Primary | High-frequency | tDCS session : direct current transcranial magnetic stimulation. MRI |
Half an hour | No |