Recruiting

Repetitive Transcranial Magnetic Stimulation

Sponsor:

University of Ottawa

Code:

NCT06333353

Conditions

Endometriosis

Pain

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Real RepetitiveTranscranial Magnetic Stimulation 5 sessions

Sham RepetitiveTranscranial Magnetic Stimulation 5 sessions

Real RepetitiveTranscranial Magnetic Stimulation 10 sessions

Sham RepetitiveTranscranial Magnetic Stimulation 10 sessions

Study Details

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.

Conditions

Endometriosis

Pain

Study ID

NCT06333353

Start date

Apr 12, 2024

Status verified date

Apr, 2024

Completion date

Jun 20, 2027

Anticipated

Primary completion date

May 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

152 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Real RepetitiveTranscranial Magnetic Stimulation 5 sessions

5 consecutive treatment sessions will be provided using a protocol based on the updated guideline (Lefaucheur, 2014) and on Pinot-Monange et al. (2019). Each treatment session will last approximately 30 minutes.

Acceptability, adverse events and side effects will be recorded after each session, while the researchers will also record the total treatment time, difficulties encountered during implementation, and any modifications to the intervention.

Sham RepetitiveTranscranial Magnetic Stimulation 5 sessions

5 consecutive sham treatment sessions will be provided using a protocol based on the updated guideline (Lefaucheur, 2014) and on Pinot-Monange et al. (2019). Each treatment session will last approximately 30 minutes.

Acceptability, adverse events and side effects will be recorded after each session, while the researchers will also record the total treatment time, difficulties encountered during implementation, and any modifications to the intervention

Real RepetitiveTranscranial Magnetic Stimulation 10 sessions

10 consective treatment sessions will be provided using a protocol based on the updated guideline (Lefaucheur, 2014) and on Pinot-Monange et al. (2019). Each treatment session will last approximatly 30 minutes.

Acceptability, adverse events and side effects will be recorded after each session, while the researchers will also record the total treatment time, difficulties encountered during implementation, and any modifications to the intervention.

Sham RepetitiveTranscranial Magnetic Stimulation 10 sessions

10 consective sham treatment sessions will be provided using a protocol based on the updated guideline (Lefaucheur, 2014) and on Pinot-Monange et al. (2019). Each treatment session will last approximatly 30 minutes.

Acceptability, adverse events and side effects will be recorded after each session, while the researchers will also record the total treatment time, difficulties encountered during implementation, and any modifications to the intervention.

Primary outcome measure

  • Numeric rating scale (NRS) used to record daily pain over 30 days [ Time Frame: Baseline -30 days after enrolment and before allocation ]
  • Numeric rating scale(NRS) used to record daily pain over 30 days [ Time Frame: 30 days following intervention ]
  • Patient Global Impression of Change (PGIC) in pain [ Time Frame: After the Intervention on the final intervention day ]
  • Patient Global Impression of Change (PGIC) in pain [ Time Frame: 30 days after completing the intervention ]
  • Patient Global Impression of Change (PGIC) in pain [ Time Frame: 6 months after the intervention ]

Central Contacts and Locations

Central contacts

Anne-Marie MacDonald, MSc

613-562-5800alake@uottawa.ca

Flavia Ignacio Antonio, PhD

8193181627fignacio@uottawa.ca

Locations

McLean Function Measurement Lab

Recruiting

Ottawa, Ontario, Canada, K1S1S2

Contacts

Anne-Marie MacDonald, MSc

613-562-5800mfmlab@uottawa.ca

Linda McLean, PhD

613-562-5800lmclea2@uottawa.ca

Principal Investigator:

Linda McLean, PhD

More Information

Sponsor

University of Ottawa

Last update posted

Apr 15, 2024

Last verified

Apr, 2024

Keywords

  • Repetitive Transcranial Magnetic Stimulation
  • intervention
  • endometriosis
  • pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Ottawa on 2024-04-15.