Clinical trial NCT03204682: Repetitive Transcranial Magnetic Stimulation as an Analgesic Treatment in Endometriosis Chronic Pain : Feasibility
Official title: Repetitive Transcranial Magnetic Stimulation as an Analgesic Treatment in Endometriosis Chronic Pain : Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deep Endometriosis
Chronic Pelvic Pain
Keywords: Endometriosis
Magnetic transcranial stimulation
Chronic pain
Analgesic
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants receive the same intervention throughout the protocol
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of patients tolerant 5 sessions of stimulation and with no increase in pain
timeFrame: at day 8
Secondary outcomes:
measure: Change in pain between the mean pain evaluated before inclusion
timeFrame: at day 8
measure: Endometriosis Health Profile Questionnaire (EPH-30);
timeFrame: at day 8
measure: Brief Pain Inventory (BPI): digital
timeFrame: at day 8
measure: Beck Questionnaire (Depression)
timeFrame: at day 8
measure: STAI of Anxiety Scale; Scale of alexythymie of Toronto
timeFrame: at day 8
measure: Catastrophizing Pain Scale (personality)
timeFrame: at day 8
measure: Quality of Life Questionnaire SF-36
timeFrame: at day 8
measure: Migraine criteria (ICHD3)
timeFrame: at day 8
measure: Gastrointestinal quality of Life Index (GICLI)
timeFrame: at day 8
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
state: Auvergne
Study officials:
affiliation: CHU de Clermont-Ferrand
name: Nicolas BOURDEL, PH
role: PRINCIPAL_INVESTIGATOR
References: