Closed-loop RTMS for Short-term Migraine Prevention

NCT06735768 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2024-12-27

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06735768 on ClinicalTrials.gov