Closed-loop RTMS for Short-term Migraine Prevention

Not Applicable

Recruiting

• Conditions: Migraine Disorders

• Registration Number: NCT06735768
• Lead Sponsor: Brightmind.AI

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-06
• Study Start: 2024-12-09
• Study First Submitted QC: 2024-12-11
• Study First Posted: 2024-12-16
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-07
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Monthly migraine days (MMD)	comparing 4 weeks before with 4 weeks after rTMS	Mean number of MMD 4 weeks before and 4 weeks after rTMS treatment.

Secondary Outcome Measures

Name	Time	Method
50 percent responder rate	comparing 4 weeks before with 4 weeks after rTMS	Responder rate as a reduction in MMD by 50 percent or more.
Weekly Migraine days after stimulation.	comparing 4 weeks before with 4 weeks after rTMS	Mean
Monthly headache days	comparing 4 weeks before with 4 weeks after rTMS	Mean number of monthly headache days before and after rTMS treatment.
Monthly (4 weeks) days with use of acute medication	comparing 4 weeks before with 4 weeks after rTMS	Mean number of monthly days with acute medication usage before and after rTMS treatment.
Headache severity	comparing 4 weeks before with 4 weeks after rTMS	Mean headache severity of migraine headaches before and after rTMS treatment.
Duration of migraine attacks	comparing 4 weeks before with 4 weeks after rTMS	Mean duration of migraine attacks before and after rTMS treatment.

Trial Locations

Locations (1)

Univ.-Klinik für Neurologie, Medizinische Universität Wien; 🇦🇹 Vienna, Austria