Context-Guided Personalized iTBS for Depression
3 августа 2026 г. обновлено: Zhi Yang, Capital Medical University
Research on Intelligent Optimization of Neuromodulation for Depression Based on Contextual Neuroimaging
The goal of this randomized clinical trial is to learn whether context-guided personalized intermittent theta burst stimulation (iTBS) works better than standard iTBS for adults with major depressive disorder. iTBS is a noninvasive treatment that uses magnetic pulses to stimulate specific areas of the brain.
Participants will be assigned by chance to one of two treatment groups. The standard treatment group will receive iTBS at a commonly used target in the left dorsolateral prefrontal cortex after watching a neutral video. The personalized treatment group will receive iTBS at an individual brain target selected using magnetic resonance imaging data. Before each treatment session, participants in this group will watch a positive emotional video intended to activate brain functions related to the selected target.
Both groups will receive five iTBS sessions per day for five consecutive treatment days. Participants will continue their stable antidepressant treatment during the study.
The main question is whether context-guided personalized iTBS results in a higher treatment response rate than standard iTBS two weeks after treatment. Treatment response is defined as a reduction of at least 50% from baseline in the 17-item Hamilton Depression Rating Scale score.
Researchers will also compare early changes in depression, anxiety and other clinical symptoms, changes in brain imaging measures, and any side effects. Clinical and brain imaging assessments will be conducted before and after the treatment course, and clinical symptoms will be assessed again two weeks after treatment.
Обзор исследования
Статус
Еще не набирают
Тип исследования
Интервенционный
Регистрация (Оцененный)
60
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Zhi Yang, PhD
- Номер телефона: +86 186 1171 0840
- Электронная почта: yangz@mail.ccmu.edu.cn
Места учебы
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Beijing Municipality
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Beijing, Beijing Municipality, Китай, 100088
- Beijing Anding Hospital, Capital Medical University
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Контакт:
- Zhi Yang, PhD
- Номер телефона: +8618611710840
- Электронная почта: yangz@mail.ccmu.edu.cn
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Нет
Описание
Inclusion Criteria:
- Male or female outpatients or inpatients aged 18 to 55 years, inclusive.
- Right-handed.
- Diagnosis of major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed using the Mini International Neuropsychiatric Interview (MINI). Both first and recurrent depressive episodes are eligible.
- A 17-item Hamilton Depression Rating Scale (HAMD-17) total score of at least 14 at both screening and baseline.
- At enrollment, participants may be antidepressant-free or may have received an antidepressant at no less than the minimum effective dose for at least 4 weeks. The antidepressant may be combined with no more than two other medications, and the type and dosage of medications must remain unchanged from enrollment until study completion.
- At least primary school education and able to understand the study procedures and requirements.
- Able to undergo magnetic resonance imaging and intermittent theta burst stimulation safely.
- Voluntarily agrees to participate and provides written informed consent.
Exclusion Criteria:
- Serious or unstable medical or neurological illness.
- Pregnancy or breastfeeding.
- History of seizure, epilepsy, hydrocephalus, or central nervous system tumor.
- Contraindication to magnetic resonance imaging, including claustrophobia, an electronic or metallic implant, or a non-removable metallic dental prosthesis.
- Receipt of systematic modified electroconvulsive therapy, transcranial magnetic stimulation, deep brain stimulation, vagus nerve stimulation, or another physical neuromodulation treatment within 3 months before screening.
- Excessive head motion during MRI scanning (rotation exceeding 3.0° and/or translation exceeding 3 mm)
- Resting motor threshold remaining at or above 70% of the device maximum stimulator output after repeated testing, when the investigator considers continued treatment to present a safety concern.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Context-Guided Personalized iTBS
Participants assigned to this arm will receive context-guided personalized intermittent theta burst stimulation (iTBS).
An individualized stimulation target in the left or right dorsolateral prefrontal cortex will be selected based on the participant's functional magnetic resonance imaging data.
Before each iTBS session, participants will watch a positive emotional video intended to engage the brain functions related to the individualized target.
Participants will receive five iTBS sessions per day, with approximately 50 minutes between sessions, for five consecutive treatment days.
Each session will last approximately 10 minutes and deliver 1,800 pulses at 100% of the resting motor threshold.
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An individualized stimulation target in the left or right dorsolateral prefrontal cortex is selected using the participant's functional magnetic resonance imaging data.
Before each stimulation session, the participant watches a positive emotional video intended to engage brain functions related to the selected target.
Intermittent theta burst stimulation is delivered at 100% of the resting motor threshold.
Each session delivers 1,800 pulses over approximately 10 minutes.
Participants receive five sessions per day, with approximately 50 minutes between sessions, for five consecutive treatment days.
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Активный компаратор: Standard Left DLPFC iTBS
Participants assigned to this arm will receive standard intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex.
Before each iTBS session, participants will watch a neutral video.
Participants will receive five iTBS sessions per day, with approximately 50 minutes between sessions, for five consecutive treatment days.
Each session will last approximately 10 minutes and deliver 1,800 pulses at 100% of the resting motor threshold.
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Intermittent theta burst stimulation is delivered to a standard treatment target in the left dorsolateral prefrontal cortex.
Before each stimulation session, the participant watches a neutral video.
Stimulation is delivered at 100% of the resting motor threshold.
Each session delivers 1,800 pulses over approximately 10 minutes.
Participants receive five sessions per day, with approximately 50 minutes between sessions, for five consecutive treatment days.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Treatment Response Rate at 2-Week Follow-up Based on HAMD-17
Временное ограничение: At 2 weeks after completion of treatment (Day 21 ± 2 days).
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The treatment response rate is defined as the proportion of participants with a reduction of at least 50% from baseline in the total score of the 17-item Hamilton Depression Rating Scale (HAMD-17) at the 2-week follow-up.
The HAMD-17 is a clinician-rated scale used to assess the severity of depressive symptoms, with lower scores indicating fewer depressive symptoms.
Treatment response rates will be compared between the context-guided personalized iTBS arm and the standard left DLPFC iTBS arm.
The HAMD-17 total score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity.
Change from baseline is calculated as the post-baseline score minus the baseline score, with negative values indicating improvement.
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At 2 weeks after completion of treatment (Day 21 ± 2 days).
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Incidence of Adverse Events
Временное ограничение: From the first treatment session through the 2-week follow-up after completion of treatment
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The number and proportion of participants experiencing one or more adverse events will be recorded for each treatment arm.
Adverse events may include headache, scalp discomfort, muscle twitching, transient mood changes, or other adverse events occurring during the treatment and follow-up periods.
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From the first treatment session through the 2-week follow-up after completion of treatment
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Early Treatment Response Rate Based on HAMD-17
Временное ограничение: Baseline to immediately after completion of the treatment intervention
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Early treatment response is defined as a reduction of at least 20% from baseline in the total score of the 17-item Hamilton Depression Rating Scale (HAMD-17) immediately after completion of the treatment intervention.
The outcome will be summarized as the proportion of participants meeting this response criterion in each treatment arm.
Lower HAMD-17 scores indicate fewer depressive symptoms.
The HAMD-17 total score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity.
Change from baseline is calculated as the post-baseline score minus the baseline score, with negative values indicating improvement.
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Baseline to immediately after completion of the treatment intervention
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Change From Baseline in HAMD-17 Factor Scores
Временное ограничение: Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
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Changes from baseline in the prespecified factor scores of the 17-item Hamilton Depression Rating Scale (HAMD-17) will be assessed at the 2-week follow-up.
For each factor, the change score will be calculated as the follow-up score minus the baseline score.
A greater reduction indicates greater improvement in the corresponding depressive symptom domain.
The HAMD-17 consists of 17 items; 9 items are scored from 0 to 4 and 8 items are scored from 0 to 2. The total score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity.
Change is calculated as the post-baseline score minus the baseline score; negative values indicate improvement.
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Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
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Change From Baseline in QIDS-SR16 Total Score
Временное ограничение: Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
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Changes from baseline in the total score of the 16-item Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16) will be assessed immediately after completion of the treatment intervention and at the 2-week follow-up.
Lower scores indicate fewer self-reported depressive symptoms.
The QIDS-SR16 total score ranges from 0 to 27, with higher scores indicating greater depressive symptom severity.
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Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
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Change From Baseline in HAMA Total Score
Временное ограничение: Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
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Changes from baseline in the total score of the Hamilton Anxiety Rating Scale (HAMA) will be assessed immediately after completion of the treatment intervention and at the 2-week follow-up.
The HAMA is a clinician-rated measure of anxiety symptom severity, with lower scores indicating fewer anxiety symptoms.
The 14-item HAMA total score ranges from 0 to 56, with higher scores indicating greater anxiety symptom severity.
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Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Zhi Yang, PhD, Beijing Anding Hospital, Capital Medical University
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 сентября 2026 г.
Первичное завершение (Оцененный)
30 октября 2027 г.
Завершение исследования (Оцененный)
30 октября 2027 г.
Даты регистрации исследования
Первый отправленный
29 июля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
29 июля 2026 г.
Первый опубликованный (Действительный)
3 августа 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
5 августа 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
3 августа 2026 г.
Последняя проверка
1 августа 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- BRWEP2024W072120106
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Описание плана IPD
Individual participant data will not be shared because the current informed consent and ethics-approved protocol authorize the coded and de-identified clinical and neuroimaging data for use within this study only.
Study data will be stored and analyzed on a secure internal institutional server.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .