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

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

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.

Study Overview

• Status: Unknown
• Conditions: Deep Endometriosis; Chronic Pelvic Pain
• Intervention / Treatment: Device: Repetitive transcranial magnetic stimulation

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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Auvergne
    • Clermont-Ferrand, Auvergne, France, 63003
      • Recruiting
      • CHU de Clermont-Ferrand
      • Principal Investigator: Nicolas BOURDEL, PH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients tolerant 5 sessions of stimulation and with no increase in pain	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	at day 8

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Nicolas BOURDEL, PH, CHU de Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2016
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: June 28, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Chronic pain; Endometriosis; Analgesic; Magnetic transcranial stimulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Endometriosis; Pelvic Pain
• Other Study ID Numbers: CHU-341; 2015-A01371-48 (Other Identifier: 2015-A01371-48)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No