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Behavioural Intervention

Real RepetitiveTranscranial Magnetic Stimulation (rTMS) 5 sessions for Endometriosis

N/A
Recruiting
Led By Linda McLean, PhD
Research Sponsored by University of Ottawa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline -30 days after enrolment and before allocation
Awards & highlights

Study Summary

This trial aims to improve pain outcomes for Canadian women with endometriosis. It will test the effectiveness of a repetitive transcranial magnetic stimulation (rTMS) intervention for reducing pain in individuals

Who is the study for?
This trial is for Canadian women, girls, and gender-diverse individuals newly diagnosed with endometriosis who experience chronic pain after other interventions. Participants should have persistent post-operative endometriosis-associated pain.Check my eligibility
What is being tested?
The study tests if repetitive transcranial magnetic stimulation (rTMS) can reduce chronic pain in endometriosis patients. It compares real rTMS against a sham (placebo) treatment over two different durations: short-term (5 sessions) and long-term (10 sessions).See study design
What are the potential side effects?
While the side effects of rTMS are generally mild, they may include discomfort at the stimulation site, headache, lightheadedness or seizures in very rare cases.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline -30 days after enrolment and before allocation
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline -30 days after enrolment and before allocation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Numeric rating scale (NRS) used to record daily pain over 30 days
Numeric rating scale(NRS) used to record daily pain over 30 days
Patient Global Impression of Change (PGIC) in pain
Secondary outcome measures
Adherence to the intervention protocol
Conditioned pain modulation (CPM)
Female Sexual Distress Scale (FSDS)
+12 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Real RepetitiveTranscranial Magnetic Stimulation (rTMS) 5 sessionsExperimental Treatment1 Intervention
The real rTMS intervention will be delivered to the primary motor cortex (M1) on the left side, over the hand representation, using high frequency (HF) rTMS applied by way of a Magstim Rapid² system. The coil position and orientation will be standardized between treatment visits through using a Brainsight neuronavigation system (Rogue Research, Canada). Each of 5 rTMS sessions will consist of a total of 1500 pulses: 15 sets of pulses delivered at 10Hz for 10s at 80% resting motor threshold (RMT), separated by 50s intervals. The real rTMS intervention will be delivered daily over 5 consecutive days.
Group II: Real RepetitiveTranscranial Magnetic Stimulation (rTMS) 10 sessionsExperimental Treatment1 Intervention
The real 10-session rTMS intervention will be the same as that delivered for the real 5-session rTMS intervention, but delivered as 5 daily sessions, a two day break, and 5 more daily sessions.
Group III: Sham RepetitiveTranscranial Magnetic Stimulation (rTMS) 5 sessionsPlacebo Group1 Intervention
The sham rTMS intervention will be delivered to the primary motor cortex (M1) on the left side, over the hand representation, using high frequency (HF) rTMS applied by way of a Magstim Rapid² system interfaced with a placebo coil, whose position and orientation will standardized between treatment visits using a Brainsight neuronavigation system (Rogue Research, Canada) The sham stimulation target will be individually defined at baseline as the site eliciting the highest averaged motor evoked potential (MEP) peak-to-peak amplitude in the first dorsal interosseous (FDI) muscle. Each of 5 sham rTMS sessions will consist of a total of 1500 sham pulses: 15 sets of sham pulses (0% output) delivered at 10Hz for 10s, separated by 50s intervals. The sham intervention will be delivered daily over 5 consecutive days.
Group IV: Sham RepetitiveTranscranial Magnetic Stimulation (rTMS) 10 sessionsPlacebo Group1 Intervention
The sham 10 session rTMS intervention will be delivered identically to the sham 5 session intervention, but delivered as 5 daily sessions, a two day break, and 5 more daily sessions.

Find a Location

Who is running the clinical trial?

University of OttawaLead Sponsor
208 Previous Clinical Trials
267,004 Total Patients Enrolled
Linda McLean, PhDPrincipal InvestigatorUniversity of Ottawa
2 Previous Clinical Trials
236 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to participate in this clinical investigation?

"To be eligible for participation in this study, individuals must have a diagnosis of endometriosis and fall between the ages of 18 and 40. The trial aims to recruit approximately 152 participants."

Answered by AI

What specific objectives does this medical study aim to fulfill?

"The primary target of this clinical investigation, observed for approximately 30 days post-intervention, is the Numeric Rating Scale (NRS) to document daily pain levels. Supplementary objectives encompass Perceived Pain Intensity (PPI), which involves applying an algometer device to assess perceived pain intensity based on prior pressure thresholds obtained from each participant at all designated sites. Following pressure application, participants will rate their discomfort using a numerical scale ranging from 0 to 10. Additionally, adherence to the treatment protocol entails monitoring attendance at repetitive transcranial magnetic stimulation (rTMS) sessions. Lastly, the Beck Depression Inventory-II (BDI-II)"

Answered by AI

Is the enrollment process open for this medical study at present?

"As per information from clinicaltrials.gov, this particular trial is currently not accepting new participants. It was initially posted on April 1st, 2024, and last revised on March 26th, 2024. Despite the inactive status of this study, it's essential to note that there are a substantial number of 458 ongoing clinical trials actively seeking eligible candidates."

Answered by AI

Are individuals above the age of 50 eligible to participate in this research trial?

"This trial is open to individuals aged above 18 years and below 40 years."

Answered by AI
Recent research and studies
Pain PracticeJournal
The Development and Psychometric Validation of the Central Sensitization Inventory
Mayer, Tom G., Randy Neblett, Howard Cohen, Krista J. Howard, Yun H. Choi, Mark J. Williams, Yoheli Perez, and Robert J. Gatchel. 2011. “The Development and Psychometric Validation of the Central Sensitization Inventory”. Pain Practice. Wiley. doi:10.1111/j.1533-2500.2011.00493.x.
Obstetrics & GynecologyJournal
Association of Chronic Pelvic Pain and Endometriosis with Signs of Sensitization and Myofascial Pain
Stratton, Pamela, Izabella Khachikyan, Ninet Sinaii, Robin Ortiz, and Jay Shah. 2015. “Association of Chronic Pelvic Pain and Endometriosis with Signs of Sensitization and Myofascial Pain”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000000663.
clinicaltrials.govStudy
Is Repetitive Transcranial Magnetic Stimulation Effective in Reducing Endometriosis-associated Pain
Dr. Linda McLean 2024. "Is Repetitive Transcranial Magnetic Stimulation Effective in Reducing Endometriosis-associated Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06333353.
All > Intervention > Endometriosis
~101 spots leftby May 2027
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