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Low-Intensity Focused Ultrasound Targeting the Dorsolateral Prefrontal Cortex for Preventive Treatment of Chronic Migraine

28 septembre 2026 mis à jour par: Zhao Dong, MD, Chinese PLA General Hospital

Efficacy and Safety of Low-Intensity Focused Ultrasound Targeting the Dorsolateral Prefrontal Cortex for Preventive Treatment of Chronic Migraine in Adults: A Randomized, Single-Blind, Sham-Controlled Trial

Chronic migraine is a disabling neurological disorder characterized by frequent headache attacks and significant impairment of quality of life. Low-intensity focused ultrasound (LIFUS) is a non-invasive neuromodulation technique that can precisely target deep brain regions. This study aims to evaluate the efficacy, safety, and tolerability of LIFUS targeting the left dorsolateral prefrontal cortex (DLPFC) for preventive treatment of chronic migraine in adults.

This is a randomized, single-blind, sham-controlled clinical trial. Eligible participants with chronic migraine will be randomly assigned to receive either active LIFUS stimulation targeting the left DLPFC or sham stimulation. Participants will receive 10 stimulation sessions over 2 weeks and will be followed for 3 months after intervention.

The primary outcome is the change in monthly migraine days from baseline to 1 month after intervention. Secondary and exploratory outcomes include headache-related disability, quality of life, psychological assessments, electrophysiological measurements, neuroimaging changes, and safety outcomes.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

36

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

  • Nom: Mingjie Zhang, Doctor
  • Numéro de téléphone: (+86) 18910276582
  • E-mail: mjzhangnk@163.com

Lieux d'étude

  • Chine
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chine
        • Chinese People's Liberation Army General Hospital, First Medical Center
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Participants diagnosed with chronic migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3), with a history of migraine for at least 12 months before screening.
  • Migraine onset at or before 50 years of age.
  • During the 3 months before screening, participants have headache occurring on at least 15 days per month, with migraine features or migraine-specific treatment on at least 8 days per month.
  • During the baseline prospective electronic headache diary period, participants record at least 8 migraine days and 15 to 27 headache days.
  • Participants are able to comply with electronic headache diary recording requirements, with data recorded for at least 24 of the 28 days during the screening period.
  • Age between 18 and 65 years at screening visit.
  • Participants are willing and able to provide written informed consent and comply with study procedures.

Exclusion Criteria:

  • History of epilepsy, brain tumor, or traumatic brain injury.
  • History of transcranial magnetic stimulation, transcranial direct current stimulation, or electroconvulsive therapy within the past 3 months.
  • Presence of MRI-incompatible metallic implants, including but not limited to vascular stents, cardiac pacemakers, or ventriculoperitoneal shunts.
  • Clinically significant comorbid chronic pain conditions, such as fibromyalgia, chronic low back pain, or complex regional pain syndrome.
  • Diagnosis of acute or active temporomandibular disorder.
  • History or diagnosis of other primary headache disorders, including chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or atypical migraine subtypes.
  • Use of opioid-containing analgesics for more than 4 days within 1 month before baseline or during baseline period.
  • Use of any migraine preventive medication within 1 month prior to screening.
  • Use of devices or surgical interventions for migraine treatment within 1 month before baseline, including transcranial magnetic stimulation, greater occipital nerve block, or invasive/non-invasive neuromodulation procedures.
  • History of malignant tumors within the past 5 years, except adequately treated localized basal cell carcinoma or carcinoma in situ of the cervix.
  • History of severe psychiatric disorders, including schizophrenia, other psychotic disorders, bipolar disorder, obsessive-compulsive disorder, or post-traumatic stress disorder.
  • Severe anxiety, depression, or manic symptoms according to predefined scale thresholds (SAS, SDS, and BRMS).
  • Significant risk of self-harm or harm to others based on the Columbia Suicide Severity Rating Scale (C-SSRS) assessment or investigator judgment.
  • History of myocardial infarction, stroke, transient ischemic attack, unstable angina, coronary artery bypass surgery, or other revascularization procedures within 12 months before screening.
  • Pregnancy or breastfeeding.
  • Claustrophobia or inability to undergo MRI examination.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: DLPFC-LIFUS
Dispositif: Low-Intensity Focused Ultrasound Stimulation

Participants receive active low-intensity focused ultrasound stimulation targeting the left dorsolateral prefrontal cortex (DLPFC) for preventive treatment of chronic migraine.
Comparateur factice: DLPFC-Sham
Dispositif: Sham Low-Intensity Focused Ultrasound Stimulation

Participants undergo sham stimulation procedures with identical positioning, coupling, and treatment duration as the active stimulation group, but without effective ultrasound output.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Monthly Migraine Days
Délai: Baseline and 1 month after intervention

Change in monthly migraine days from baseline after intervention.
Baseline and 1 month after intervention

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Acute Headache Medication Days
Délai: Baseline and 1 month after intervention

Change in the number of days using acute headache medications from baseline to 1 month after intervention.
Baseline and 1 month after intervention
50% Responder Rate Based on Monthly Migraine Days
Délai: 1 month after intervention

Proportion of participants achieving at least 50% reduction in monthly migraine days compared with baseline.
1 month after intervention
75% Responder Rate Based on Monthly Migraine Days
Délai: 1 month after intervention

Proportion of participants achieving at least 75% reduction in monthly migraine days compared with baseline.
1 month after intervention
Change in Moderate/Severe Headache Days
Délai: Baseline and 1 month after intervention

Change in the number of moderate or severe headache days from baseline to 1 month after intervention.
Baseline and 1 month after intervention
Change in Visual Analog Scale (VAS) Score for Headache Intensity
Délai: Immediately after each intervention session to 1 month after intervention

Headache intensity is assessed using the Visual Analog Scale (VAS). Scores range from 0 to 10, with higher scores indicating greater headache intensity.
Immediately after each intervention session to 1 month after intervention
Change in Most Bothersome Migraine Symptom (MBS) Improvement Score
Délai: Immediately after intervention and 1 month after intervention

Participants identify their most bothersome migraine-associated symptom at baseline from nausea, vomiting, photophobia, or phonophobia. The same symptom is assessed during follow-up using a 7-point patient-reported improvement scale ranging from very much improved to very much worse.
Immediately after intervention and 1 month after intervention
Change in monthly Migraine Disability Assessment (mMIDAS) Score
Délai: Baseline, immediately after intervention, and 1 month after intervention

The monthly Migraine Disability Assessment (mMIDAS) questionnaire assesses migraine-related disability during the previous month. Higher scores indicate greater migraine-related disability.
Baseline, immediately after intervention, and 1 month after intervention
Change in Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) Score
Délai: Baseline, immediately after intervention, and 1 month after intervention
Baseline, immediately after intervention, and 1 month after intervention
Change in Headache Impact Test-6 (HIT-6) Score
Délai: Baseline, immediately after intervention, and 1 month after intervention

The 6-item Headache Impact Test (HIT-6) assesses the impact of headache on daily functioning. Total scores range from 36 to 78, with higher scores indicating greater headache impact.
Baseline, immediately after intervention, and 1 month after intervention
Patient Global Impression of Change (PGI-C) Score
Délai: Immediately after intervention and 1 month after intervention

The Patient Global Impression of Change (PGI-C) is a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), with higher scores indicating less favorable perceived change.
Immediately after intervention and 1 month after intervention
Change in Generalized Anxiety Disorder 7-item (GAD-7) Score
Délai: Baseline, immediately after intervention, and 1 month after intervention

The Generalized Anxiety Disorder 7-item (GAD-7) scale assesses anxiety symptoms. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Baseline, immediately after intervention, and 1 month after intervention
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Délai: Baseline, immediately after intervention, and 1 month after intervention

The Patient Health Questionnaire-9 (PHQ-9) assesses depressive symptoms. Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.
Baseline, immediately after intervention, and 1 month after intervention
Incidence of Adverse Events
Délai: From baseline through completion of the 3-month follow-up visit

Number and proportion of participants who experience one or more adverse events during the study. All observed and spontaneously reported adverse events will be recorded regardless of their relationship to the study intervention; severity and relatedness will also be assessed.
From baseline through completion of the 3-month follow-up visit
Number of Participants with New Abnormal Findings on T2-Weighted MRI
Délai: Baseline and within 24 hours after the final intervention session

Number of participants with new brain parenchymal signal abnormalities, hemorrhage, or edema identified on T2-weighted MRI within 24 hours after the final intervention compared with baseline.
Baseline and within 24 hours after the final intervention session

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Long-term Change in Monthly Acute Headache Medication Days
Délai: 2 and 3 months after intervention

Change in the number of days using acute headache medications compared with baseline during extended follow-up
2 and 3 months after intervention
Long-term Migraine Responder Rate (≥50%)
Délai: 2 and 3 months after intervention

Proportion of participants achieving at least 50% reduction in monthly migraine days compared with baseline during extended follow-up.
2 and 3 months after intervention
Long-term Change in Moderate/Severe Headache Days
Délai: 2 and 3 months after intervention

Change in monthly moderate/severe headache days compared with baseline during extended follow-up.
2 and 3 months after intervention
Long-term Change in Migraine Disability (mMIDAS)
Délai: 2 and 3 months after intervention

Change in monthly Migraine Disability Assessment (mMIDAS) score compared with baseline during extended follow-up.
2 and 3 months after intervention
Long-term Change in Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) Score
Délai: 2 and 3 months after intervention

Change in migraine-specific quality of life assessed using the MSQ v2.1 questionnaire compared with baseline during extended follow-up.
2 and 3 months after intervention
Long-term Change in Headache Impact Test-6 (HIT-6) Score
Délai: 2 and 3 months after intervention

Change in headache-related impact assessed using the HIT-6 questionnaire compared with baseline during extended follow-up.
2 and 3 months after intervention

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Chinese PLA General Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

8 octobre 2026

Achèvement primaire (Estimé)

31 décembre 2027

Achèvement de l'étude (Estimé)

30 avril 2028

Dates d'inscription aux études

Première soumission

11 septembre 2026

Première soumission répondant aux critères de contrôle qualité

28 septembre 2026

Première publication (Réel)

5 octobre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • S2026-344-01

Plan pour les données individuelles des participants (IPD)

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NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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