Using closed-loop rTMS to prevent migraines

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

This study is testing if a new type of brain stimulation can help people who get frequent migraines feel better and have fewer headaches.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 88 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Brightmind.AI (Industry-sponsored)
• Drugs / interventions: Erenumab, Fremanezumab, Galcanezumab
• Locations: 1 site (Vienna, State of Vienna)
• Trial ID: NCT06735768 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of repetitive transcranial magnetic stimulation (rTMS) as a preventive treatment for migraine disorders. It aims to gather reliable data on the short-term effects of rTMS, following established guidelines for controlled trials of migraine treatment. Participants will undergo rTMS treatment while their motor hotspot and threshold are determined, and their migraine frequency will be monitored. The study focuses on individuals experiencing frequent migraines to assess the potential benefits of this noninvasive technique.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a history of migraine without aura, migraine with aura, or chronic migraine, experiencing at least four migraine days per month.

Not a fit: Patients with fewer than four migraine days per month or those who have had changes in medication usage in the three months prior to the study may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new preventive treatment option for individuals suffering from frequent migraines.

How similar studies have performed: While there is limited data on rTMS for migraine prevention, this study aims to fill a gap in the current understanding and may provide new insights into its effectiveness.

Eligibility criteria

Inclusion criteria:

* 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.

Exclusion criteria:

* 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
* Known severe adverse reactions in response to rTMS
* Patients diagnosed with bipolar disorder, substance use disorders or psychosis
* Patients with a known medical history, as well as a family history, of seizures.
* Patients experiencing chronic sleep deprivation
* Patients with structural CNS disorders such as a brain tumor, stroke, or traumatic brain injury.
* Patients with chronic tinnitus in the judgement of the investigator
* Patients with other disorders interfering with the study in the judgement of the investigator.
* Treatment with another investigational drug or other intervention until the end of the study
* Botulinum toxin-based infusions for cosmetic reasons at the forehead within a period of six months prior to study inclusion until the final visit.
* Other clinically relevant pain syndromes
* Depression or anxiety in the judgement of the investigator as assessed by means of BDI-II (score 20 or above) and DASS-21 (score 14 or above).
* Severe health risks in the judgement of the investigator. In particular this includes assessing the risk associated with a history of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.

Where this trial is running

Vienna, State of Vienna

• Univ.-Klinik für Neurologie, Medizinische Universität Wien — Vienna, State of Vienna, Austria (Recruiting)

Study contacts

• Principal investigator: Christian Wöber, Prof., PhD — Medical University Vienna
• Study coordinator: Luca Ticini, PhD

Conditions Migraine Disorders