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NCT Number: NCT07442916

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

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Key information

Conditions

Chronic Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Headache Disorders, Secondary Medication Overuse Headache Migraine Disorders Nervous System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Translational Neurophysiology

Pavia, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

Active rTMS Motor Cortex Face

Other

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 Forearm

Other

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 rTMS

Other

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.

Primary outcomes

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

    Time frame: 1 month post-treatment

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

Secondary outcomes

  1. Number of participants converting from chronic to episodic migraine

    Time frame: Up to 3 months post-treatment

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

  2. Change in monthly number of acute headache medication intakes

    Time frame: Up to 3 months post-treatment

    Reduction in medication overuse assessed by patient diary

  3. Acute headache medications

    Time frame: Up to 3 months post-treatment

    Monthly consumption of acute headache medications

  4. Number of participants initiating preventive migraine therapy

    Time frame: Up to 3 months post-treatment

    Initiation of preventive migraine therapy during follow-up

  5. Change in Quantitative Sensory Testing (QST)

    Time frame: Up to 3 months post-treatment

    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.

  6. Change in plasma glutamate concentration

    Time frame: Up to 3 months post-treatment

    Changes in plasma levels of glutamate

  7. Change in plasma serotonin concentration

    Time frame: Up to 3 months post-treatment

    Changes in plasma levels of serotonin

  8. Change in plasma CGRP concentration

    Time frame: Up to 3 months post-treatment

    Changes in plasma levels of CGRP

Sponsors and collaborators

Lead sponsor

IRCCS National Neurological Institute "C. Mondino" Foundation

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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