Deep EndometriosisENDOSTIMNCT03204682
Repetitive Transcranial Magnetic Stimulation as an Analgesic Treatment in Endometriosis Chronic Pain : Feasibility
A study testing Repetitive transcranial magnetic stimulation in people with Deep Endometriosis and Chronic Pelvic Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Deep Endometriosis, Chronic Pelvic Pain
- What is being tested?
- Repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 13 Apr 2016to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Nicolas BOURDEL, PH
About this study
Official title: 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.
Read the 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
- Conditions
- Deep Endometriosis, Chronic Pelvic Pain
- Being tested
- Repetitive transcranial magnetic stimulation
- Keywords
- Endometriosis, Magnetic transcranial stimulation, Chronic pain, Analgesic
- Medical subject headings
- Endometriosis, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at day 8
Secondary outcomes (9)
Change in pain between the mean pain evaluated before inclusion
thanks to the visual analogue scale traded between 0 and 100
Measured: at day 8
Endometriosis Health Profile Questionnaire (EPH-30);
Variation in scores of questionnaires before and after stimulation
Measured: at day 8
Brief Pain Inventory (BPI): digital
Variation in scores of questionnaires before and after stimulation
Measured: at day 8
Beck Questionnaire (Depression)
Variation in scores of questionnaires before and after stimulation
Measured: at day 8
STAI of Anxiety Scale; Scale of alexythymie of Toronto
Variation in scores of questionnaires before and after stimulation
Measured: at day 8
Catastrophizing Pain Scale (personality)
Variation in scores of questionnaires before and after stimulation
Measured: at day 8
Quality of Life Questionnaire SF-36
Variation in scores of questionnaires before and after stimulation
Measured: at day 8
Migraine criteria (ICHD3)
Variation in scores of questionnaires before and after stimulation
Measured: at day 8
Gastrointestinal quality of Life Index (GICLI)
Variation in scores of questionnaires before and after stimulation
Measured: at day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start13 Apr 2016
- Primary completionApr 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep EndometriosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive the same intervention throughout the protocol
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas BOURDEL, PH, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204682
- Sponsor's protocol ID
- CHU-341
- Other IDs
- 2015-A01371-48
- Acronym
- ENDOSTIM
- Status last verified
- Jun 2017
- First submitted
- 26 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation as an Analgesic Treatment in Endometriosis Chronic Pain : Feasibility Study
- ClinicalTrials.gov ID
- NCT03204682
- Acronym / sponsor ID
- ENDOSTIM / CHU-341
- Conditions
- Deep Endometriosis, Chronic Pelvic Pain
- Keywords
- Endometriosis, Magnetic transcranial stimulation, Chronic pain, Analgesic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 13 Apr 2016 (actual)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive the same intervention throughout the protocol
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic refractory endometriosis pain | Experimental | Device: Repetitive transcranial magnetic stimulationThe aim of the study is to evaluate the feasibility of transcranial magnetic stimulation (rTMS) for analgesia on chronic refractory endometriosis pain. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive transcranial magnetic stimulationRealization 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 | Device | Patients with chronic refractory endometriosis pain |
Primary outcome
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
9 secondary outcomes
Change in pain between the mean pain evaluated before inclusion
Time frame: at day 8
Endometriosis Health Profile Questionnaire (EPH-30);
Time frame: at day 8
Brief Pain Inventory (BPI): digital
Time frame: at day 8
Beck Questionnaire (Depression)
Time frame: at day 8
STAI of Anxiety Scale; Scale of alexythymie of Toronto
Time frame: at day 8
Catastrophizing Pain Scale (personality)
Time frame: at day 8
Quality of Life Questionnaire SF-36
Time frame: at day 8
Migraine criteria (ICHD3)
Time frame: at day 8
Gastrointestinal quality of Life Index (GICLI)
Time frame: at day 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas BOURDEL, PH principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation in people with Deep Endometriosis and Chronic Pelvic Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients tolerant 5 sessions of stimulation and with no increase in pain (time frame: at day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.