Closed-loop RTMS for Short-term Migraine Prevention

NCT06735768 | Recruiting

• 1 other identifier: 2145/2023
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (1)

• Monthly migraine days (MMD)

  Mean number of MMD 4 weeks before and 4 weeks after rTMS treatment.

  comparing 4 weeks before with 4 weeks after rTMS

Secondary Outcomes (6)

• 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

Study Arms (2)

Active group

ACTIVE COMPARATOR

This group receives rTMS treatment.

Device: rTMS treatment; Device: Determination of motor hotspot and motor treshold

Sham group

SHAM COMPARATOR

This group receives sham treatment.

Device: Determination of motor hotspot and motor treshold

Interventions

rTMS treatment DEVICE

Brightmind.AI´s rTMS protocol is applied

Active group

Determination of motor hotspot and motor treshold DEVICE

Determination of motor hotspot and motor treshold

Active group; Sham group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 18-65
• Migraine without aura, migraine with aura or chronic migraine according to the diagnostic criteria of the third edition of the International Classification of Headache Disorders (ICHD-3) - Age of onset before 50 years of age
• At least 4 migraine days in each of three subsequent 4- week periods preceding the screening period. (Subsequently, the investigators use month synonymous for 4-week periods)
• At least 4 migraine days during one month of baseline prior to treatment.
• Ability to distinguish migraine headaches from other headache types (e.g., tension-type headaches)
• Willing to adhere to the rTMS regimen and able to monitor MD in Migraine diary
• No changes in medication usage/regime for three months before the start of treatment (incl. use of acute abortion / rescue medication). In case of Erenumab, Fremanezumab, Galcanezumab no changes in usage/regime for six months before the start of treatment. Every medication is reported and documented.
• No changes in medication usage/regime during the entire study period (i.e., keeping acute intervention protocol as previously handled for the past three months; not introducing new approaches in intervention/ prevention during this time period (such as anti-nausea drugs not previously taken)). Every medication is reported \& documented.
• Use of a single drug for migraine prophylaxis is permitted as long as the dosage has not been altered within 3 months of starting the study and the dosage must not be altered for the entire duration of the study.
• No other stimulation techniques.
• No change in acupuncture, relaxation training, biofeedback, behavioral therapy or other psychological or psychotherapeutic interventions for three months preceding the study and during the entire study period investigator.
• Ability to read and understand the written information (patient information, migraine diary, CRF and Adverse Events (AE) collecting form)
• Completed baseline headache diary with missing data on not more than 5 of 28 days.

You may not qualify if:

• More than 26 headache days in any of three subsequent months preceding the screening visit.
• More than 26 headache days during baseline
• Pregnant persons
• Usage of Onabotulinumtoxin A for managing chronic migraines.
• Medication-overuse according to ICHD-3
• Presence of metals or implanted devices that can be in close proximity the of device (i.e., above the neckline) and can be adversely affected by magnetic fields including:
• Stents
• Implanted stimulators
• Implanted vagus nerve or brain implants incl. deep brain stimulators
• Implanted electrical devices
• Cochlear implants for hearing
• Any magnetic implants
• Bullet fragments
• Grenade fragments
• Presence of heart pacemakers, defibrillator, intracardiac lines or medication pumps

Sponsors & Collaborators

• Brightmind.AI: lead
• Medical University of Vienna: collaborator

Study Sites (1)

Univ.-Klinik für Neurologie, Medizinische Universität Wien

Vienna, Vienna, 1010, Austria

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Christian Wöber, Prof., PhD

  Medical University Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Ticini, PhD

CONTACT

0043019470414; luca.ticini@brightmind.ai

Gregor Kowarik, PhD

CONTACT

0043019470414; gregor.kowarik@brightmind.ai

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 16, 2024
• Study Start: December 9, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)