NCT03204682

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

2 years

First QC Date

June 26, 2017

Last Update Submit

June 28, 2017

Conditions

Deep EndometriosisChronic Pelvic Pain

Keywords

EndometriosisMagnetic transcranial stimulationChronic painAnalgesic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Change in pain between the mean pain evaluated before inclusion

    at day 8

  • Endometriosis Health Profile Questionnaire (EPH-30);

    at day 8

  • Brief Pain Inventory (BPI): digital

    at day 8

  • Beck Questionnaire (Depression)

    at day 8

  • STAI of Anxiety Scale; Scale of alexythymie of Toronto

    at day 8

  • +4 more secondary outcomes

Study Arms (1)

Patients with chronic refractory endometriosis pain

EXPERIMENTAL

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

Interventions

Repetitive transcranial magnetic stimulationDEVICE

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

Patients with chronic refractory endometriosis pain

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

RECRUITING

MeSH Terms

Conditions

EndometriosisChronic Pain

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Nicolas BOURDEL, PH

    CHU de Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Open
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All participants receive the same intervention throughout the protocol
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2017

First Posted

July 2, 2017

Study Start

April 13, 2016

Primary Completion

April 1, 2018

Study Completion

May 1, 2018

Last Updated

July 2, 2017

Record last verified: 2017-06

Locations

FR(1)