Double-blind, Randomized, Sham-controlled Study of Closed-loop Repetitive Transcranial Magnet Stimulation (rTMS) for the Short-term Prevention of Migraine
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Migraine Disorders
- Sponsor
- Brightmind.AI
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Monthly migraine days (MMD)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
Migraine is a prevalent and debilitating primary headache disorder, where patients suffer from disabling symptoms that usually consist of a moderate to severe headache lasting 4 to 72 hours, nausea and/or vomiting, phonophobia and photophobia. Transcranial magnetic stimulation (TMS) is a noninvasive technique that is considered to be safe. Repetitive TMS (rTMS) might be useful for migraine prophylaxis. However, available studies on the use of rTMS for preventive treatment of migraine are limited. Currently, rTMS is not recommended in the recent guidelines for the treatment of migraine published by the German Neurological Society in 2022.
Therefore, the aim of the current study is to provide reliable data on the short-term effect of rTMS for the prevention of migraine. The investigators will follow the Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: Fourth edition, with the exception of study duration, which will be limited to four weeks of baseline, three sessions of rTMS within a 10-day timeframe and 4 weeks of follow-up as our study aims to examine short-term efficacy.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Monthly migraine days (MMD)
Time Frame: comparing 4 weeks before with 4 weeks after rTMS
Mean number of MMD 4 weeks before and 4 weeks after rTMS treatment.
Secondary Outcomes
- 50 percent responder rate(comparing 4 weeks before with 4 weeks after rTMS)
- Weekly Migraine days after stimulation.(comparing 4 weeks before with 4 weeks after rTMS)
- Monthly headache days(comparing 4 weeks before with 4 weeks after rTMS)
- Monthly (4 weeks) days with use of acute medication(comparing 4 weeks before with 4 weeks after rTMS)
- Headache severity(comparing 4 weeks before with 4 weeks after rTMS)
- Duration of migraine attacks(comparing 4 weeks before with 4 weeks after rTMS)