Repetitive Transcranial Magnetic Stimulation as an Analgesic Treatment in Endometriosis Chronic Pain : Feasibility
NCT ID: NCT03204682
Last Updated: 2017-07-02
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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UNKNOWN
NA
24 participants
INTERVENTIONAL
2016-04-13
2018-05-31
Brief Summary
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The aim of the study is to evaluate the feasibility of transcranial magnetic stimulation (rTMS) for analgesia on chronic refractory endometriosis pain.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients with chronic refractory endometriosis pain
The aim of the study is to evaluate the feasibility of transcranial magnetic stimulation (rTMS) for analgesia on chronic refractory endometriosis pain.
Repetitive transcranial magnetic stimulation
Realization of a brain and medullary MRI to allow neuronavigation. Realization of 5 sessions of rTMS in 5 days during the first week then evaluation (physical examination, questionnaires) in consultation on post-stimulation. Then followed for 28 days in total through self-assessment of pain that will be filled daily on REDCap and last consultation on D28 for further evaluation
Interventions
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Repetitive transcranial magnetic stimulation
Realization of a brain and medullary MRI to allow neuronavigation. Realization of 5 sessions of rTMS in 5 days during the first week then evaluation (physical examination, questionnaires) in consultation on post-stimulation. Then followed for 28 days in total through self-assessment of pain that will be filled daily on REDCap and last consultation on D28 for further evaluation
Eligibility Criteria
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Inclusion Criteria
* Not pregnant or breastfeeding;
* At least one painful symptoms related to the existence of endometriosis (dyspareunia, dysmenorrhea, pain with defecation or urination, neuropathic pain);
* Average VAS\> 4/10, at least 4 days out of 7 for at least 3 months;
* Hormonal treatment failure continued in association or not for pain control;
* A level of understanding and satisfying expression in French;
* Monitoring possible during the duration of the study (4 weeks).
* These patients should be affiliated to the French social security and should have signed a written consent after receiving clear information.
Exclusion Criteria
* Industrial accident or notion of litigation
* Cons-indication for rTMS (cortical lesion within 2cm of the motor cortex, ECT treatment during previous month, epilepsy and / or a history of epilepsy, history of head trauma, intracranial hypertension;
* Metal clip; pacemaker,
* Pregnant or breastfeeding women;
* Pain lasting less than 3 months;
* Another pain more severe than that associated with endometriosis;
* Lack of filling of the computerized questionnaires on Redcap;
* Incapable of understanding about informed consent,
* Patient under guardianship.
18 Years
55 Years
FEMALE
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Nicolas BOURDEL, PH
Role: PRINCIPAL_INVESTIGATOR
CHU de Clermont-Ferrand
Locations
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CHU de Clermont-Ferrand
Clermont-Ferrand, Auvergne, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2015-A01371-48
Identifier Type: OTHER
Identifier Source: secondary_id
CHU-341
Identifier Type: -
Identifier Source: org_study_id
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