Is Repetitive Transcranial Magnetic Stimulation Effective in Reducing Endometriosis-associated Pain: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• self-reported endometriosis-associated pain (\> 3 in the numeric rating scale, 0-10) that has persisted following medical or surgical intervention,

Locations
Other Locations
Canada
McLean Function Measurement Lab
RECRUITING
Ottawa
Contact Information
Primary
Anne-Marie MacDonald, MSc
alake@uottawa.ca
613-562-5800
Backup
Flavia Ignacio Antonio, PhD
fignacio@uottawa.ca
8193181627
Time Frame
Start Date: 2024-04-12
Estimated Completion Date: 2027-06-20
Participants
Target number of participants: 152
Treatments
Experimental: Real RepetitiveTranscranial Magnetic Stimulation (rTMS) 5 sessions
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.
Sham_comparator: Sham RepetitiveTranscranial Magnetic Stimulation (rTMS) 5 sessions
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.
Experimental: Real RepetitiveTranscranial Magnetic Stimulation (rTMS) 10 sessions
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.
Sham_comparator: Sham RepetitiveTranscranial Magnetic Stimulation (rTMS) 10 sessions
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.
Related Therapeutic Areas
Sponsors
Leads: University of Ottawa

This content was sourced from clinicaltrials.gov