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Chronic MigraineNCT07442916

Non-Invasive Brain Stimulation as Add-on Treatment in Chronic Migraine With Medication Overuse

A study testing Active rTMS Motor Cortex Face and Active rTMS - Motor Cortex Forearm in people with Chronic Migraine and Medication Overuse Headache, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized, double-blind, sham-controlled clinical trial aims to evaluate the efficacy of non-invasive brain stimulation as an add-on treatment to standard detoxification therapy in patients with chronic migraine and medication overuse. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Chronic Migraine, Medication Overuse Headache
What is being tested?
Active rTMS Motor Cortex Face and Active rTMS - Motor Cortex Forearm
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteItaly
Study dates
2 Jan 2024to 30 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of chronic migraine and medication overuse according to ICHD-3 criteria
  • Ability to provide written informed consent

Who cannot join

  • Major psychiatric disorders (e.g., major depressive disorder)
  • Changes in preventive migraine therapy within the last 3 months
  • Ongoing treatment with monoclonal antibodies for migraine prevention
  • Other significant neurological or systemic diseases
  • Pregnancy
  • Contraindications to transcranial magnetic stimulation (for main study participants)

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Translational Neurophysiology

    Pavia, 27100

Other trials in Italy

About this study

Official title: Identification of Predictors of Treatment Response and Innovative Therapeutic Strategies Based on Non-Invasive Brain Stimulation in Patients With Chronic Migraine and Medication Overuse

This randomized, double-blind, sham-controlled clinical trial aims to evaluate the efficacy of non-invasive brain stimulation as an add-on treatment to standard detoxification therapy in patients with chronic migraine and medication overuse. The study also seeks to identify sensory and biochemical biomarkers predictive of treatment response.

Read the detailed description

The main study is a randomized controlled trial enrolling patients with chronic migraine and medication overuse (MoH). Participants will undergo a standardized in-hospital detoxification protocol and will be randomly assigned to one of three parallel groups to receive either sham stimulation, active repetitive transcranial magnetic stimulation (rTMS) applied over the motor cortex face representation, or active rTMS applied over the motor cortex forearm representation. Stimulation will be delivered for five consecutive days.

Clinical, sensory (Quantitative Sensory Testing, QST), and biochemical measures (plasma glutamate, serotonin, and calcitonin gene-related peptide, CGRP) will be collected at baseline and during follow-up.

Being tested
Active rTMS Motor Cortex Face, Active rTMS - Motor Cortex Forearm, Sham rTMS
Keywords
Migraine, Non-Invasive Brain Stimulation, Medication Overuse Headache, Transcranial Magnetic Stimulation, rTMS
Medical subject headings
Headache Disorders, Secondary, Migraine Disorders

What participants receive

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

  • Active rTMS Motor Cortex FaceOther

    Participants will undergo a standardized in-hospital detoxification protocol for medication overuse and will receive high-frequency (10 Hz) active repetitive transcranial magnetic stimulation (rTMS) applied over the primary motor cortex corresponding to the face representation. Stimulation will be administered once daily for five consecutive days during hospitalization.

  • Active rTMS - Motor Cortex ForearmOther

    Participants will undergo a standardized in-hospital detoxification protocol for medication overuse and will receive high-frequency (10 Hz) active repetitive transcranial magnetic stimulation (rTMS) applied over the primary motor cortex corresponding to the forearm representation. Stimulation will be administered once daily for five consecutive days during hospitalization.

  • Sham rTMSOther

    Participants will undergo a standardized in-hospital detoxification protocol for medication overuse and will receive sham high-frequency (10 Hz) repetitive transcranial magnetic stimulation (rTMS). Sham stimulation will be delivered using identical stimulation parameters and session duration as active rTMS, with the coil positioned to avoid effective cortical stimulation. Treatment will be administered once daily for five consecutive days during hospitalization.

Study groups in NCT07442916
Study groupRoleWhat they receive
Active rTMS - Motor Cortex Face RepresentationExperimentalParticipants will undergo a standardized in-hospital detoxification protocol for medication overuse and will receive high-frequency (10 Hz) active repetitive transcranial magnetic stimulation (rTMS) applied over the primary motor cortex corresponding to the face representation. Stimulation will be administered once daily for five consecutive days during hospitalization.
Receives: Other: Active rTMS Motor Cortex Face
Active rTMS - Motor Cortex Forearm RepresentationExperimentalParticipants will undergo a standardized in-hospital detoxification protocol for medication overuse and will receive high-frequency (10 Hz) active repetitive transcranial magnetic stimulation (rTMS) applied over the primary motor cortex corresponding to the forearm representation. Stimulation will be administered once daily for five consecutive days during hospitalization.
Receives: Other: Active rTMS - Motor Cortex Forearm
Sham rTMSSham comparatorParticipants will undergo a standardized in-hospital detoxification protocol for medication overuse and will receive sham high-frequency (10 Hz) repetitive transcranial magnetic stimulation (rTMS). Sham stimulation will be delivered using identical stimulation parameters and session duration as active rTMS, with the coil positioned to avoid effective cortical stimulation. Treatment will be administered once daily for five consecutive days during hospitalization.
Receives: Other: Sham rTMS

What is being measured

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

  1. Number of monthly days with moderate-to-severe headache

    Change in the mean number of monthly days with moderate-to-severe headache during the month following treatment

    Measured: 1 month post-treatment

Secondary outcomes (8)

  1. Number of participants converting from chronic to episodic migraine

    Conversion from chronic to episodic migraine (<15 headache days/month) assessed by headache diary

    Measured: Up to 3 months post-treatment

  2. Change in monthly number of acute headache medication intakes

    Reduction in medication overuse assessed by patient diary

    Measured: Up to 3 months post-treatment

  3. Acute headache medications

    Monthly consumption of acute headache medications

    Measured: Up to 3 months post-treatment

  4. Number of participants initiating preventive migraine therapy

    Initiation of preventive migraine therapy during follow-up

    Measured: Up to 3 months post-treatment

  5. Change in Quantitative Sensory Testing (QST)

    Changes in sensory and pain thresholds assessed by QST. QST is a panel of diagnostic tests used to assess somatosensory function. The panel of tests examine a broad range of different sensations, including hot, cold, touch, vibration. It has both positive and negative tests (can test for increased or reduced sensitivity). QST reflects a formalisation of existing neurological tests into a standardised battery designed to detect subtle changes in sensory function.

    Measured: Up to 3 months post-treatment

  6. Change in plasma glutamate concentration

    Changes in plasma levels of glutamate

    Measured: Up to 3 months post-treatment

  7. Change in plasma serotonin concentration

    Changes in plasma levels of serotonin

    Measured: Up to 3 months post-treatment

  8. Change in plasma CGRP concentration

    Changes in plasma levels of CGRP

    Measured: Up to 3 months post-treatment

Timeline

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

  1. First posted2 Mar 2026
  2. Study start2 Jan 2024
  3. Primary completion30 Jan 2026
  4. Study completion30 Jan 2026

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07442916
Sponsor's protocol ID
COSENTINO-MIGRAINE-TMS-2026
Status last verified
Feb 2026
First submitted
19 Feb 2026
Last updated
2 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Brighina F, Piazza A, Vitello G, Aloisio A, Palermo A, Daniele O, Fierro B. rTMS of the prefrontal cortex in the treatment of chronic migraine: a pilot study. J Neurol Sci. 2004 Dec 15;227(1):67-71. doi: 10.1016/j.jns.2004.08.008.

    PubMed 15546593

  • Knotkova H, Hamani C, Sivanesan E, Le Beuffe MFE, Moon JY, Cohen SP, Huntoon MA. Neuromodulation for chronic pain. Lancet. 2021 May 29;397(10289):2111-2124. doi: 10.1016/S0140-6736(21)00794-7.

    PubMed 34062145

  • Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.

    PubMed 19833552

Questions about this trial

What is this clinical trial studying?

A study testing Active rTMS Motor Cortex Face and Active rTMS - Motor Cortex Forearm in people with Chronic Migraine and Medication Overuse Headache, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.

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 2 inclusion and 6 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: finished, as of the sponsor's last update on 2 Mar 2026. 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 Italy. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of monthly days with moderate-to-severe headache (time frame: 1 month post-treatment). 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 NCT07442916, which also lists 3 linked publications.

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 2 Mar 2026.

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