Accelerated iTBS for PTSD and Depression
15 сентября 2026 г. обновлено: Lawson Research Institute of St. Joseph's
Accelerated Intermittent Theta Burst Stimulation for Depression in Post-Traumatic Stress Disorder: A Single-Arm, Open-Label Feasibility Study
The goal of this pilot clinical trial is to learn if a faster brain stimulation schedule is practical, safe, tolerable, and acceptable. This study looks at accelerated intermittent theta burst stimulation, or accelerated iTBS. This is a non-invasive type of magnetic brain stimulation. This study is for adults with post-traumatic stress disorder (PTSD) and major depressive disorder (MDD).
The main questions this study aims to answer are:
- Can participants complete six short brain stimulation sessions per day for five days?
- Is this treatment schedule safe and tolerable for participants?
- What changes occur in depression symptoms, PTSD symptoms, anxiety, quality of life, and brain activity over time?
Participants will:
- Complete health screening and baseline assessments.
- Receive six short sessions of magnetic brain stimulation per day for five days.
- Have their brain activity measured using an EEG recording.
- Return for a post-treatment assessment at Week 2 and follow-up visits at Week 5 and Week 12.
Обзор исследования
Статус
Рекрутинг
Вмешательство/лечение
Подробное описание
This is a single-arm, open-label pilot feasibility study of accelerated intermittent theta burst stimulation, also called accelerated iTBS, in adults with both post-traumatic stress disorder (PTSD) and major depressive disorder (MDD).
The study is designed to assess whether an accelerated iTBS schedule can be delivered safely, tolerably, and feasibly in a clinical setting.
The main focus is feasibility, including recruitment, treatment adherence, participant retention, safety, tolerability, and participant acceptability.
About 12 to 16 participants will receive active accelerated iTBS.
Treatment will include six short stimulation sessions per day over five consecutive days, for a total of 30 sessions.
The study will also collect exploratory information over time on depression symptoms, PTSD symptoms, anxiety, daily functioning, quality of life, and brain activity measured by EEG.
Because this is a small pilot study, the analysis will be mainly descriptive.
The results will help refine study procedures and guide the design of a larger future clinical trial.
Тип исследования
Интервенционный
Регистрация (Оцененный)
16
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: Radhika Kelkar, MD
- Номер телефона: 75805 519-685-8500
- Электронная почта: radhika.kelkar@lhsc.on.ca
Учебное резервное копирование контактов
- Имя: Mervin Blair, PhD, C.Psych
- Номер телефона: 48170 519-646-6100
- Электронная почта: mervin.blair@sjhc.london.on.ca
Места учебы
-
-
Ontario
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London, Ontario, Канада, N6C 0A7
- Рекрутинг
- St. Joseph's Health Care London, Parkwood Institute Mental Health Care Building
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Контакт:
- Radhika Kelkar, MD
- Номер телефона: 75805 519-685-8500
- Электронная почта: radhika.kelkar@lhsc.on.ca
-
Контакт:
- Mervin Blair, PhD, C.Psych
- Номер телефона: 48170 519-646-6100
- Электронная почта: mervin.blair@sjhc.london.on.ca
-
Главный следователь:
- Radhika Kelkar, MD
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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
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
Inclusion Criteria:
- Adults aged 18 years or older.
- Current post-traumatic stress disorder (PTSD) and current major depressive disorder (MDD), confirmed by a structured diagnostic interview (e.g., MINI 6.0 using the PTSD and MDD modules).
- Minimum symptom severity at baseline: HAMD-17 score ≥14 (moderate depression) and/or PCL-5 score ≥33 (probable PTSD).
- On a stable pharmacologic and/or psychotherapeutic regimen for at least 4 weeks prior to baseline, and willing to maintain stability during the treatment phase, unless medically necessary.
- Capacity to provide informed consent and comply with study procedures and visits at St. Joseph's Health Care, London/Parkwood Institute.
- Sufficient English proficiency to complete consent and study assessments.
Exclusion Criteria:
- Neurologic or device-related risks, including seizure history, traumatic brain injury with loss of consciousness greater than 5 minutes, major neurologic illness, or metal/electronic implants contraindicated for transcranial magnetic stimulation.
- Psychiatric or substance-related risks, including current psychotic disorder, acute mania, diagnosis of Bipolar I or Bipolar II disorder, recent substance use disorder, or imminent suicide risk.
- Medical or medication-related risks, including unstable severe illness, high-risk medications, hearing impairment, unwillingness to use ear protection, or prior non-response to an adequate course of theta burst stimulation for the current depression/PTSD episode.
- Enrollment in another interventional trial.
- Inability to comply with the study schedule.
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: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Accelerated iTBS
Participants will receive active accelerated intermittent theta burst stimulation (iTBS).
Treatment will consist of six short stimulation sessions per day delivered over five consecutive days, for a total of 30 sessions.
|
Accelerated intermittent theta burst stimulation, also called accelerated iTBS, is a non-invasive magnetic brain stimulation intervention.
Stimulation is delivered to the left dorsolateral prefrontal cortex using a transcranial magnetic stimulation system.
Participants receive six short sessions per day over five consecutive days.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Recruitment rate
Временное ограничение: Study recruitment period, up to 12 months
|
Recruitment rate will be assessed as the number of participants enrolled per month during the active recruitment period.
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Study recruitment period, up to 12 months
|
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Consent rate
Временное ограничение: Study recruitment period, up to 12 months
|
Consent rate will be assessed as the proportion of eligible individuals approached who provide informed consent.
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Study recruitment period, up to 12 months
|
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Treatment adherence
Временное ограничение: Treatment Days 1 through 5
|
Treatment adherence will be assessed as the percentage of scheduled accelerated iTBS sessions completed during the 5-day treatment course.
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Treatment Days 1 through 5
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Retention through Week 12 follow-up
Временное ограничение: Baseline through Week 12
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Retention will be assessed as the proportion of enrolled participants who complete the Week 12 follow-up visit.
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Baseline through Week 12
|
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Adverse events
Временное ограничение: Treatment Days 1 through Week 12
|
Adverse events will be assessed as the proportion of participants who experience one or more adverse events during treatment and follow-up.
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Treatment Days 1 through Week 12
|
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Serious adverse events
Временное ограничение: Treatment Days 1 through Week 12
|
Serious adverse events will be assessed as the proportion of participants who experience one or more serious adverse events during treatment and follow-up.
|
Treatment Days 1 through Week 12
|
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Discontinuations due to adverse events
Временное ограничение: Treatment Days 1 through Week 12
|
Tolerability will be assessed as the proportion of participants who discontinue accelerated iTBS because of adverse events.
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Treatment Days 1 through Week 12
|
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Participant satisfaction with accelerated iTBS
Временное ограничение: Week 2, Week 5, and Week 12
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Participant satisfaction will be assessed using a 5-point Likert satisfaction rating scale.
Scores range from 1 to 5, with higher scores indicating greater satisfaction.
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Week 2, Week 5, and Week 12
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Participant feedback on accelerated iTBS
Временное ограничение: Week 2, Week 5, and Week 12
|
Participant feedback will be assessed using brief feedback questions about the accelerated iTBS treatment schedule and overall study experience.
Responses will be summarized descriptively.
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Week 2, Week 5, and Week 12
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Exploratory change in clinician-rated depression symptom severity measured by HAMD-17
Временное ограничение: Baseline, Week 2, Week 5, and Week 12
|
Clinician-rated depression symptom severity will be assessed using the Hamilton Depression Rating Scale-17.
Total scores range from 0 to 52, with higher scores indicating greater depression symptom severity.
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Baseline, Week 2, Week 5, and Week 12
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Exploratory change in self-reported depression symptom severity measured by PHQ-9
Временное ограничение: Baseline, Week 2, Week 5, and Week 12
|
Self-reported depression symptom severity will be assessed using the Patient Health Questionnaire-9.
Total scores range from 0 to 27, with higher scores indicating greater depression symptom severity.
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Baseline, Week 2, Week 5, and Week 12
|
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Exploratory change in self-reported PTSD symptom severity measured by PCL-5
Временное ограничение: Baseline, Week 2, Week 5, and Week 12
|
Self-reported PTSD symptom severity will be assessed using the PTSD Checklist for DSM-5.
Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
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Baseline, Week 2, Week 5, and Week 12
|
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Exploratory change in clinician-rated PTSD symptom severity measured by CAPS-5
Временное ограничение: Baseline, Week 2, and Week 12
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Clinician-rated PTSD symptom severity will be assessed using the Clinician-Administered PTSD Scale for DSM-5.
Total symptom severity scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
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Baseline, Week 2, and Week 12
|
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Exploratory change in anxiety symptom severity measured by GAD-7
Временное ограничение: Baseline, Week 2, Week 5, and Week 12
|
Anxiety symptom severity will be assessed using the Generalized Anxiety Disorder-7 item Scale.
Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
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Baseline, Week 2, Week 5, and Week 12
|
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Exploratory change in cognitive function measured by MoCA
Временное ограничение: Baseline, Week 2, Week 5, and Week 12
|
Cognitive function will be assessed using the Montreal Cognitive Assessment.
Total scores range from 0 to 30, with higher scores indicating better cognitive function.
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Baseline, Week 2, Week 5, and Week 12
|
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Exploratory change in functioning and disability measured by WHODAS 2.0
Временное ограничение: Baseline, Week 2, Week 5, and Week 12
|
Functioning and disability will be assessed using the WHO Disability Assessment Schedule 2.0
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Baseline, Week 2, Week 5, and Week 12
|
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Exploratory change in quality of life measured by Q-LES-Q-SF
Временное ограничение: Baseline, Week 2, Week 5, and Week 12
|
Quality of life will be assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form.
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Baseline, Week 2, Week 5, and Week 12
|
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Baseline clinical global severity measured by CGI-S
Временное ограничение: Baseline
|
Clinical global severity will be assessed using the Clinical Global Impression-Severity scale.
Scores range from 1 to 7, with higher scores indicating greater illness severity.
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Baseline
|
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Exploratory change in clinical global improvement measured by CGI-I
Временное ограничение: Week 2, Week 5, and Week 12
|
Clinical global improvement will be assessed using the Clinical Global Impression-Improvement scale.
Scores range from 1 to 7, with lower scores indicating greater clinical improvement.
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Week 2, Week 5, and Week 12
|
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Exploratory change in resting-state EEG alpha power
Временное ограничение: Baseline, Treatment Day 1, and Treatment Day 5
|
Resting-state EEG alpha power recorded at frontal electrodes will be assessed using EEG recordings collected at baseline and on treatment Days 1 and 5. On Days 1 and 5, brief resting-state EEG recordings will be collected immediately before and after each iTBS session to explore neurophysiological changes associated with accelerated iTBS.
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Baseline, Treatment Day 1, and Treatment Day 5
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Exploratory change in resting-state EEG gamma power
Временное ограничение: Baseline, Treatment Day 1, and Treatment Day 5
|
Resting-state EEG gamma power recorded at frontal electrodes will be assessed using EEG recordings collected at baseline and on treatment Days 1 and 5. On Days 1 and 5, brief resting-state EEG recordings will be collected immediately before and after each iTBS session to explore neurophysiological changes associated with accelerated iTBS.
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Baseline, Treatment Day 1, and Treatment Day 5
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Radhika Kelkar, MD, St. Joseph's Health Care London, Parkwood Institute, Finch Family Mental Health Care Building
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)
1 июня 2027 г.
Завершение исследования (Оцененный)
1 сентября 2027 г.
Даты регистрации исследования
Первый отправленный
9 июня 2026 г.
Впервые представлено, что соответствует критериям контроля качества
26 июня 2026 г.
Первый опубликованный (Действительный)
2 июля 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
18 сентября 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
15 сентября 2026 г.
Последняя проверка
1 сентября 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- AiTBS-PTSD-MDD--001
- 127851 (Другой идентификатор: Western HSREB Project ID)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
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. .