Repetitive Transcranial Magnetic Stimulation in Central Neuropathic Pain
NCT ID: NCT02386969
Last Updated: 2021-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2015-11-11
2018-09-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Active rTMS then sham rTMS
Active rTMS in 1st period and sham rTMS in 2nd period
active rTMS then sham rTMS
A first period during which the patient will have 1 session of active rTMS every 3 weeks for 3 months A 2nd period during which the patient will have 1 session of sham rTMS every 3 weeks for 3 months
Sham rTMS then active rTMS
Sham rTMS in 1st period and active rTMS in 2nd period
sham rTMS then active rTMS
A first period during which the patient will have 1 session of sham rTMS every 3 weeks for 3 months A 2nd period during which the patient will have 1 session of active rTMS every 3 weeks for 3 months
Interventions
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active rTMS then sham rTMS
A first period during which the patient will have 1 session of active rTMS every 3 weeks for 3 months A 2nd period during which the patient will have 1 session of sham rTMS every 3 weeks for 3 months
sham rTMS then active rTMS
A first period during which the patient will have 1 session of sham rTMS every 3 weeks for 3 months A 2nd period during which the patient will have 1 session of active rTMS every 3 weeks for 3 months
Eligibility Criteria
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Inclusion Criteria
* Chronic pain with an average pain intensity is greater than or equal to 40/100
* Pain presents a daily or almost daily (at least 4 days out of 7)
* Pain presents for more than 6 months
* Patients who signed informed consent,
* Patients whose pain medication is stable for 15 days before to inclusion, and will not need to be modified for the duration of the study,
* Patients can be monitored for the duration of the study (29 weeks)
* Patients affiliated to a health insurance plan or entitled,
* Patients with a cerebral MRI T1.
Exclusion Criteria
* Contraindication to rTMS (treatment with electroconvulsive therapy during the previous month, epilepsy and / or a history of epilepsy, history of head trauma, neurosurgical injury; intracranial hypertension metal clip; pacemaker pregnant or lactating women)
* Abuse of drugs or psychoactive substances
* Peripheral Neuropathic Pain,
* Neuropathic pain within the framework of a progressive disease (HIV, cancer, non-stabilized system disease)
* Intermittent pain,
* Pain in less than 6 months,
* Presence of other pain more severe than that justify inclusion,
* Lack of stability pain scores on two successive evaluations, defined as a change of more than 30% between the two assessments of the average pain between the first two visits (inclusion and first session)
* Patients unable to understand informed consent, under guardianship,
* Patients refusing to stop or can not stop the prohibited treatment during the study,
* Patients participating in another research protocol involving a drug within 30 days before inclusion.
18 Years
75 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Roland PEYRON, MD PhD
Role: PRINCIPAL_INVESTIGATOR
CHU de Saint-Etienne
Locations
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Chu Saint-Etienne
Saint-Etienne, , France
Countries
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Other Identifiers
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2015-A00065-44
Identifier Type: OTHER
Identifier Source: secondary_id
1408207
Identifier Type: -
Identifier Source: org_study_id
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