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

This study is currently recruiting participants.
Verified June 2017 by University Hospital, Clermont-Ferrand
Sponsor:
ClinicalTrials.gov Identifier:
NCT03204682
First Posted: July 2, 2017
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
  Purpose

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 Intervention
Deep Endometriosis Chronic Pelvic Pain Device: Repetitive transcranial magnetic stimulation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
All 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Percentage of patients tolerant 5 sessions of stimulation and with no increase in pain [ Time Frame: 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 [ Time Frame: at day 8 ]
    thanks to the visual analogue scale traded between 0 and 100

  • Endometriosis Health Profile Questionnaire (EPH-30); [ Time Frame: at day 8 ]
    Variation in scores of questionnaires before and after stimulation

  • Brief Pain Inventory (BPI): digital [ Time Frame: at day 8 ]
    Variation in scores of questionnaires before and after stimulation

  • Beck Questionnaire (Depression) [ Time Frame: at day 8 ]
    Variation in scores of questionnaires before and after stimulation

  • STAI of Anxiety Scale; Scale of alexythymie of Toronto [ Time Frame: at day 8 ]
    Variation in scores of questionnaires before and after stimulation

  • Catastrophizing Pain Scale (personality) [ Time Frame: at day 8 ]
    Variation in scores of questionnaires before and after stimulation

  • Quality of Life Questionnaire SF-36 [ Time Frame: at day 8 ]
    Variation in scores of questionnaires before and after stimulation

  • Migraine criteria (ICHD3) [ Time Frame: at day 8 ]
    Variation in scores of questionnaires before and after stimulation

  • Gastrointestinal quality of Life Index (GICLI) [ Time Frame: at day 8 ]
    Variation in scores of questionnaires before and after stimulation


Estimated Enrollment: 24
Actual Study Start Date: April 13, 2016
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03204682


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, Auvergne, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Nicolas BOURDEL, PH         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Nicolas BOURDEL, PH CHU de Clermont-Ferrand
  More Information

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03204682     History of Changes
Other Study ID Numbers: CHU-341
2015-A01371-48 ( Other Identifier: 2015-A01371-48 )
First Submitted: June 26, 2017
First Posted: July 2, 2017
Last Update Posted: July 2, 2017
Last Verified: June 2017

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

Keywords provided by University Hospital, Clermont-Ferrand:
Endometriosis
Magnetic transcranial stimulation
Chronic pain
Analgesic

Additional relevant MeSH terms:
Chronic Pain
Endometriosis
Pelvic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Genital Diseases, Female
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs