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

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Unknown status

CT.gov ID

NCT03204682

Collaborator

(none)

Enrollment

Location

Arm

24.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Deep Endometriosis Chronic Pelvic Pain	Device: Repetitive transcranial magnetic stimulation	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

All participants receive the same intervention throughout the protocolAll participants receive the same intervention throughout the protocol

Masking:

None (Open Label)

Masking Description:

Open

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 13, 2016

Anticipated Primary Completion Date :

Apr 1, 2018

Anticipated Study Completion Date :

May 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 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

Arm

Intervention/Treatment

Experimental: 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.

Device: 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

Outcome Measures

Primary Outcome Measures

Percentage of patients tolerant 5 sessions of stimulation and with no increase in pain [at day 8]
The feasibility of rTMS treatment was defined if 7 patients or more over 12 tolerate the 5 sessions of stimulation showed no increase in pain

Secondary Outcome Measures

Change in pain between the mean pain evaluated before inclusion [at day 8]
thanks to the visual analogue scale traded between 0 and 100
Endometriosis Health Profile Questionnaire (EPH-30); [at day 8]
Variation in scores of questionnaires before and after stimulation
Brief Pain Inventory (BPI): digital [at day 8]
Variation in scores of questionnaires before and after stimulation
Beck Questionnaire (Depression) [at day 8]
Variation in scores of questionnaires before and after stimulation
STAI of Anxiety Scale; Scale of alexythymie of Toronto [at day 8]
Variation in scores of questionnaires before and after stimulation
Catastrophizing Pain Scale (personality) [at day 8]
Variation in scores of questionnaires before and after stimulation
Quality of Life Questionnaire SF-36 [at day 8]
Variation in scores of questionnaires before and after stimulation
Migraine criteria (ICHD3) [at day 8]
Variation in scores of questionnaires before and after stimulation
Gastrointestinal quality of Life Index (GICLI) [at day 8]
Variation in scores of questionnaires before and after stimulation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.