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

Chronic Pelvic Pain Clinical Trial

— ENDOSTIM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03204682
• Other study ID #: CHU-341
• Secondary ID: 2015-A01371-48
• Status: Recruiting
• Phase: N/A
• First received: June 26, 2017
• Last updated: June 28, 2017
• Start date: April 13, 2016
• Est. completion date: May 2018

Study information

• Verified date: June 2017
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: May 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pelvic Pain
• Deep Endometriosis
• Endometriosis
• Pelvic Pain

Intervention

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

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand	Auvergne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

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