Closed-loop RTMS for Short-term Migraine Prevention
NCT06735768 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88
Last updated 2024-12-27
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.
Conditions
- Migraine Disorders
Interventions
- DEVICE
-
rTMS treatment
Brightmind.AI´s rTMS protocol is applied
- DEVICE
-
Determination of motor hotspot and motor treshold
Determination of motor hotspot and motor treshold
Sponsors & Collaborators
-
Medical University of Vienna
collaborator OTHER -
Brightmind.AI
lead INDUSTRY
Principal Investigators
-
Christian Wöber, Prof., PhD · Medical University Vienna
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-09
- Primary Completion
- 2025-07-31
- Completion
- 2025-08-31
Countries
- Austria
Study Locations
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