Repetitive Transcranial Magnetic Stimulation as an Analgesic Treatment in Endometriosis Chronic Pain : Feasibility

NCT ID: NCT03204682

Last Updated: 2017-07-02

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-13

Study Completion Date

2018-05-31

Brief Summary

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Endometriosis is associated with different types of pain (acute, chronic, excess nociception, neuropathic) generated by different mechanisms in the nervous system. The rTMS could provide significant analgesia for 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.

Detailed Description

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The first step consists of the inclusion of 12 patients followed by the filling by each patient of the RedCap software of five simple numerical scales for 4 weeks . 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

Conditions

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Deep Endometriosis Chronic Pelvic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants receive the same intervention throughout the protocol
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open

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.

Group Type EXPERIMENTAL

Repetitive transcranial magnetic stimulation

Intervention Type DEVICE

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Premenopausal (presence of at least one of the two ovaries and absence of clinical signs of menopause),
* 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

* Prior treatment with rTMS,
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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France

Central Contacts

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Patrick LACARIN

Role: CONTACT

04 73 75 11 95

Facility Contacts

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Patrick LACARIN

Role: primary

04 73 75 11 95

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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