Repetitive Transcranial Magnetic Stimulation for Endometriosis Pain

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 30 days after the final intervention session

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.

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).

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months following the intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months following the intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months following the intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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.

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