Low-Intensity Focused Ultrasound Targeting the Dorsolateral Prefrontal Cortex for Preventive Treatment of Chronic Migraine
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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Zhao Dong, Doctor
- Número de telefone: (+86) 18910685535
- E-mail: dong_zhaozhao@126.com
Estude backup de contato
- Nome: Mingjie Zhang, Doctor
- Número de telefone: (+86) 18910276582
- E-mail: mjzhangnk@163.com
Locais de estudo
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Beijing Municipality
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Beijing, Beijing Municipality, China
- Chinese People's Liberation Army General Hospital, First Medical Center
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Contato:
- Zhao Dong
- Número de telefone: (+86) 18910685535
- E-mail: dong_zhaozhao@126.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: DLPFC-LIFUS
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Participants receive active low-intensity focused ultrasound stimulation targeting the left dorsolateral prefrontal cortex (DLPFC) for preventive treatment of chronic migraine. |
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Comparador Falso: DLPFC-Sham
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Participants undergo sham stimulation procedures with identical positioning, coupling, and treatment duration as the active stimulation group, but without effective ultrasound output. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Monthly Migraine Days
Prazo: Baseline and 1 month after intervention
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Change in monthly migraine days from baseline after intervention. |
Baseline and 1 month after intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Acute Headache Medication Days
Prazo: Baseline and 1 month after intervention
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Change in the number of days using acute headache medications from baseline to 1 month after intervention. |
Baseline and 1 month after intervention
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50% Responder Rate Based on Monthly Migraine Days
Prazo: 1 month after intervention
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Proportion of participants achieving at least 50% reduction in monthly migraine days compared with baseline. |
1 month after intervention
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75% Responder Rate Based on Monthly Migraine Days
Prazo: 1 month after intervention
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Proportion of participants achieving at least 75% reduction in monthly migraine days compared with baseline. |
1 month after intervention
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Change in Moderate/Severe Headache Days
Prazo: Baseline and 1 month after intervention
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Change in the number of moderate or severe headache days from baseline to 1 month after intervention. |
Baseline and 1 month after intervention
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Change in Visual Analog Scale (VAS) Score for Headache Intensity
Prazo: Immediately after each intervention session to 1 month after intervention
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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
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Change in Most Bothersome Migraine Symptom (MBS) Improvement Score
Prazo: Immediately after intervention and 1 month after intervention
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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
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Change in monthly Migraine Disability Assessment (mMIDAS) Score
Prazo: Baseline, immediately after intervention, and 1 month after intervention
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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
|
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Change in Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) Score
Prazo: Baseline, immediately after intervention, and 1 month after intervention
|
Baseline, immediately after intervention, and 1 month after intervention
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Change in Headache Impact Test-6 (HIT-6) Score
Prazo: Baseline, immediately after intervention, and 1 month after intervention
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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
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Patient Global Impression of Change (PGI-C) Score
Prazo: Immediately after intervention and 1 month after intervention
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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
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Change in Generalized Anxiety Disorder 7-item (GAD-7) Score
Prazo: Baseline, immediately after intervention, and 1 month after intervention
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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
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Change in Patient Health Questionnaire-9 (PHQ-9) Score
Prazo: Baseline, immediately after intervention, and 1 month after intervention
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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
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Incidence of Adverse Events
Prazo: From baseline through completion of the 3-month follow-up visit
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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
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Number of Participants with New Abnormal Findings on T2-Weighted MRI
Prazo: Baseline and within 24 hours after the final intervention session
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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
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Long-term Change in Monthly Acute Headache Medication Days
Prazo: 2 and 3 months after intervention
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Change in the number of days using acute headache medications compared with baseline during extended follow-up |
2 and 3 months after intervention
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Long-term Migraine Responder Rate (≥50%)
Prazo: 2 and 3 months after intervention
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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
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Long-term Change in Moderate/Severe Headache Days
Prazo: 2 and 3 months after intervention
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Change in monthly moderate/severe headache days compared with baseline during extended follow-up. |
2 and 3 months after intervention
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Long-term Change in Migraine Disability (mMIDAS)
Prazo: 2 and 3 months after intervention
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Change in monthly Migraine Disability Assessment (mMIDAS) score compared with baseline during extended follow-up. |
2 and 3 months after intervention
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Long-term Change in Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) Score
Prazo: 2 and 3 months after intervention
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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
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Long-term Change in Headache Impact Test-6 (HIT-6) Score
Prazo: 2 and 3 months after intervention
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Change in headache-related impact assessed using the HIT-6 questionnaire compared with baseline during extended follow-up. |
2 and 3 months after intervention
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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Enviado pela primeira vez que atendeu aos critérios de CQ
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Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- S2026-344-01
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