NCT06333353 Is Repetitive Transcranial Magnetic Stimulation Effective in Reducing Endometriosis-associated Pain
| NCT ID | NCT06333353 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Ottawa |
| Condition | Endometriosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 152 participants |
| Start Date | 2024-04-12 |
| Primary Completion | 2027-05-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 152 participants in total. It began in 2024-04-12 with a primary completion date of 2027-05-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this research is to improve pain outcomes for the over 500K Canadian women, girls and gender-diverse individuals who are newly diagnosed with endometriosis each year. Chronic pain that persists after interventions for endometriosis is a huge problem. There is some evidence that endometriosis-associated pain (EAP) is, at least to some extent, associated with changes in pain physiology, particularly central sensitization of pain. There is currently no effective evidence-informed intervention that addresses EAP. Yet a recent feasibility trial on a repetitive transcranial magnetic stimulation (rTMS) intervention demonstrated promising results compared to a sham intervention for reducing pain in a sample with EAP. The objectives of this trial are: 1. to evaluate the effectiveness of an rTMS intervention for pain reduction among those with recalcitrant post-operative EAP, 2. to inform on the utility of a long (10 session) vs short (5 session) protocol for pain reduction among those with recalcitrant post-operative EAP 3. to determine if any improvements in pain observed 30 days after an rTMS intervention are retained 6 months later 4. to identify physical and psychosocial mediators that impact the successful reduction of pain among patients with EAP treated using rTMS. 5. to describe patients' perceptions of and satisfaction with rTMS as an intervention for EAP.
Eligibility Criteria
Inclusion Criteria: -self-reported endometriosis-associated pain (\> 3 in the numeric rating scale, 0-10) that has persisted following medical or surgical intervention, Exclusion Criteria: * Contra-indications to rTMS (e.g., metal/implants around the head/neck, pacemaker), history of epilepsy (history of seizures) in the family * Pain symptoms initiated by other known causes (e.g., infections, thyroid disease, autoimmune diseases, gastrointestinal disease) * Experience a more severe, extra-pelvic pain than that associated with endometriosis * Pregnancy
Contact & Investigator
Linda McLean, PhD
PRINCIPAL INVESTIGATOR
University of Ottawa
Frequently Asked Questions
Who can join the NCT06333353 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 60 Years, studying Endometriosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06333353 currently recruiting?
Yes, NCT06333353 is actively recruiting participants. Contact the research team at alake@uottawa.ca for enrollment information.
Where is the NCT06333353 trial being conducted?
This trial is being conducted at Ottawa, Canada.
Who is sponsoring the NCT06333353 clinical trial?
NCT06333353 is sponsored by University of Ottawa. The principal investigator is Linda McLean, PhD at University of Ottawa. The trial plans to enroll 152 participants.