AzTrials
AzTrials

Migraine DisordersNCT06735768

Closed-loop RTMS for Short-term Migraine Prevention

A study testing rTMS treatment and Determination of motor hotspot and motor treshold in people with Migraine Disorders, run by Brightmind.AI at 1 site in Austria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine Disorders
What is being tested?
rTMS treatment and Determination of motor hotspot and motor treshold
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
1 siteAustria
Study dates
9 Dec 2024to Aug 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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:
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Luca Ticini, PhD contact

0043019470414

luca.ticini@brightmind.ai

Gregor Kowarik, PhD contact

0043019470414

gregor.kowarik@brightmind.ai

Austria1 site, 1 recruiting

  • Univ.-Klinik für Neurologie, Medizinische Universität Wien

    Vienna, State of Vienna, 1010

    Christian Wöber, Prof. PhD, +43140400 ext. 31170, christian.woeber@meduniwien.ac.at

    Christian Wöber, Prof

    Recruiting

Other trials in Austria

About this study

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

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.

Being tested
rTMS treatment, Determination of motor hotspot and motor treshold
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rTMS treatmentDevice

    Brightmind.AI´s rTMS protocol is applied

  • Determination of motor hotspot and motor tresholdDevice

    Determination of motor hotspot and motor treshold

Study groups in NCT06735768
Study groupRoleWhat they receive
Active groupActive comparatorThis group receives rTMS treatment.
Receives: Device: rTMS treatment; Device: Determination of motor hotspot and motor treshold
Sham groupSham comparatorThis group receives sham treatment.
Receives: Device: Determination of motor hotspot and motor treshold

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Monthly migraine days (MMD)

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

    Measured: comparing 4 weeks before with 4 weeks after rTMS

Secondary outcomes (6)

  1. 50 percent responder rate

    Responder rate as a reduction in MMD by 50 percent or more.

    Measured: comparing 4 weeks before with 4 weeks after rTMS

  2. Weekly Migraine days after stimulation.

    Mean

    Measured: comparing 4 weeks before with 4 weeks after rTMS

  3. Monthly headache days

    Mean number of monthly headache days before and after rTMS treatment.

    Measured: comparing 4 weeks before with 4 weeks after rTMS

  4. Monthly (4 weeks) days with use of acute medication

    Mean number of monthly days with acute medication usage before and after rTMS treatment.

    Measured: comparing 4 weeks before with 4 weeks after rTMS

  5. Headache severity

    Mean headache severity of migraine headaches before and after rTMS treatment.

    Measured: comparing 4 weeks before with 4 weeks after rTMS

  6. Duration of migraine attacks

    Mean duration of migraine attacks before and after rTMS treatment.

    Measured: comparing 4 weeks before with 4 weeks after rTMS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2024
  2. Study start9 Dec 2024
  3. Primary completionJul 2025 (estimated)
  4. Study completionAug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06735768
Sponsor's protocol ID
2145/2023
Status last verified
Dec 2024
First submitted
6 Dec 2024
Last updated
27 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing rTMS treatment and Determination of motor hotspot and motor treshold in people with Migraine Disorders, run by Brightmind.AI at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Luca Ticini, PhD (0043019470414, luca.ticini@brightmind.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Monthly migraine days (MMD) (time frame: comparing 4 weeks before with 4 weeks after rTMS). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06735768.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.

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