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

Primary Purpose

Deep Endometriosis, Chronic Pelvic Pain

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Repetitive transcranial magnetic stimulation
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Endometriosis focused on measuring Endometriosis, Magnetic transcranial stimulation, Chronic pain, Analgesic

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • CHU de Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with chronic refractory endometriosis pain

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 26, 2017
Last Updated
June 28, 2017
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT03204682
Brief Title
Repetitive Transcranial Magnetic Stimulation as an Analgesic Treatment in Endometriosis Chronic Pain : Feasibility
Acronym
ENDOSTIM
Official Title
Repetitive Transcranial Magnetic Stimulation as an Analgesic Treatment in Endometriosis Chronic Pain : Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 13, 2016 (Actual)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Endometriosis, Chronic Pelvic Pain
Keywords
Endometriosis, Magnetic transcranial stimulation, Chronic pain, Analgesic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants receive the same intervention throughout the protocol
Masking
None (Open Label)
Masking Description
Open
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with chronic refractory endometriosis pain
Arm Type
Experimental
Arm Description
The aim of the study is to evaluate the feasibility of transcranial magnetic stimulation (rTMS) for analgesia on chronic refractory endometriosis pain.
Intervention Type
Device
Intervention Name(s)
Repetitive transcranial magnetic stimulation
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of patients tolerant 5 sessions of stimulation and with no increase in pain
Description
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
Time Frame
at day 8
Secondary Outcome Measure Information:
Title
Change in pain between the mean pain evaluated before inclusion
Description
thanks to the visual analogue scale traded between 0 and 100
Time Frame
at day 8
Title
Endometriosis Health Profile Questionnaire (EPH-30);
Description
Variation in scores of questionnaires before and after stimulation
Time Frame
at day 8
Title
Brief Pain Inventory (BPI): digital
Description
Variation in scores of questionnaires before and after stimulation
Time Frame
at day 8
Title
Beck Questionnaire (Depression)
Description
Variation in scores of questionnaires before and after stimulation
Time Frame
at day 8
Title
STAI of Anxiety Scale; Scale of alexythymie of Toronto
Description
Variation in scores of questionnaires before and after stimulation
Time Frame
at day 8
Title
Catastrophizing Pain Scale (personality)
Description
Variation in scores of questionnaires before and after stimulation
Time Frame
at day 8
Title
Quality of Life Questionnaire SF-36
Description
Variation in scores of questionnaires before and after stimulation
Time Frame
at day 8
Title
Migraine criteria (ICHD3)
Description
Variation in scores of questionnaires before and after stimulation
Time Frame
at day 8
Title
Gastrointestinal quality of Life Index (GICLI)
Description
Variation in scores of questionnaires before and after stimulation
Time Frame
at day 8

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas BOURDEL, PH
Organizational Affiliation
CHU de Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
State/Province
Auvergne
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Nicolas BOURDEL, PH

12. IPD Sharing Statement

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

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