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

University Hospital, Clermont-Ferrand

Status: Unknown

Conditions: Chronic Pelvic Pain; Deep Endometriosis

Treatments: Device: Repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03204682

2015-A01371-48 (Other Identifier)

CHU-341

Details and patient eligibility

About

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.

Full 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

Enrollment: 24 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Patients with chronic refractory endometriosis pain

Experimental group

Description:

The aim of the study is to evaluate the feasibility of transcranial magnetic stimulation (rTMS) for analgesia on chronic refractory endometriosis pain.

Treatment:

Device: Repetitive transcranial magnetic stimulation