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RECRUITING
NCT06735768
NA

Closed-loop RTMS for Short-term Migraine Prevention

Sponsor: Brightmind.AI

View on ClinicalTrials.gov

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.

Official title: Double-blind, Randomized, Sham-controlled Study of Closed-loop Repetitive Transcranial Magnet Stimulation (rTMS) for the Short-term Prevention of Migraine

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

88

Start Date

2024-12-09

Completion Date

2025-08

Last Updated

2024-12-27

Healthy Volunteers

No

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

Locations (1)

Univ.-Klinik für Neurologie, Medizinische Universität Wien

Vienna, Vienna, Austria