The Safety and Effectiveness of dTMS for Reducing Antipsychotic-induced Weight Gain (dTMS)
1 сентября 2026 г. обновлено: Ping Shao, Second Xiangya Hospital of Central South University
The Effects of Improving Antipsychotic-induced Weight Gain by Accelerated dTMS After Food Cue-induced Craving, A Double-Blind, Randomized, Sham-Controlled Clinical Trial.
Antipsychotic-induced metabolic disturbances, especially weight gain, are common in patients with schizophrenia.
There are no hitherto effective treatments for reducing antipsychotic-induced weight gain.
Recently, research suggest that Accelerated dTMS (a-dTMS) which deliver more than one daily TMS session indicates greater efficacy than other TMS treatment.
Symptom provocation is believed to improve the clinical responses to TMS.
In this study, the investigators, firstly, evaluate the safety and effectiveness of a-dTMS for reducing antipsychotic-induced weight gain and secondly, to establish a predictive model of therapeutic response and to explore the underlying mechanisms of dTMS for reducing antipsychotic-induced weight gain, based on multimodal radiomics and metabolomics approaches.
Обзор исследования
Статус
Еще не набирают
Подробное описание
The underlying causes of antipsychotic-induced weight gain are still unknown. Some research point out that it has something to do with metabolic disturbances and changes in appetite and food intake, acting food-craving-like behave which some points are similar to addiction. With fMRI study, it is reported having dysfunction between prefrontal and insula cortex of its cognitive regulation, interoceptive signals and reward control. dTMS, H coil in particular, simultaneously targets prefrontal and insula cortex, approved by FDA for Smoking Addiction recently. Previous study has been deconstrued that H coil could significantly improve weight gain than figure-eight Coils. Moreover, It is reckoned that TMS has state-dependent effects on brain circuitry, suspected that symptom provocation may be made it more susceptible to modulation which may improve response. Therefore, this study is to explore the efficacy of a-dTMS on antipsychotic-induced appetite, and use multimodal radiomics and metabolomics approaches to unveil the underlying mechanisms of dTMS for reducing antipsychotic-induced weight gain.
With regard to investigate this, we will be carried out a randomized, double-blind, sham-controlled clinical trial. 60 Patients with schizophrenia will be randomly treated with active a-dTMS or sham condition for 3 sections' interventions per day last for 10 days. The follow-ups are at baseline, the 12th day and the 42th day after the end of treatment. The main outcome measures include the change in body weight, BMI, TFEQ score, FCQ-S score, FCQ-T score and the resting and task-state EEG-fMRI imaging data.
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: Ping Shao
- Номер телефона: +86-13755112445
- Электронная почта: shp97jw@163.com
Учебное резервное копирование контактов
- Имя: Renrong Wu
- Номер телефона: +86-15874179855
- Электронная почта: wurenrong@csu.edu.cn
Места учебы
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Hunan
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Changsha, Hunan, Китай, 410011
- The Second Xiangya Hospital of Central South University
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Контакт:
- KaHei Chan
- Номер телефона: +86-18890384723
- Электронная почта: heimradchan@foxmail.com
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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:
- Aged between 18-60.
- Meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for schizophrenia, confirmed by the Structured Clinical Interview for DSM-5 (SCID-5).
- Gaining body weight around 7% after intaking antipsychotics within 2 years.
- Participants were on a stable medication regimen at the time of enrollment. ●Written informed consent was obtained from both the participants and their legally authorized guardians.
Exclusion Criteria:
- Participants who switch antipsychotic drugs (APDs) or require a dose modification exceeding 25% of the baseline dosage during the study period.
- Diagnosed with other mental diseases in accordance with DSM-V.
- Comorbid with other severe physiological diseases.
- Active suicidal ideation.
- A history of alcohol or substance use disorder (or abuse).
- Presence of metal implants or any other conditions contraindicated for magnetic resonance imaging (MRI).
- Presence of intracranial metal or electronic devices, a personal or family history of epilepsy, or any other standard contraindications to deep transcranial magnetic stimulation.
- Receipt of regular transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), or weight-loss interventions within the past month.
- Pregnant or lactating women
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: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: a-dTMS stimulation
The patients in a-dTMS stimulation group will receive accelerated intermittent theta burst stimulation (ACC-iTBS) stimulation for 10 consecutive days and 3 times per day.
There will have at least 50 minutes interval between each intervention.
Participants will be undertaking symptom provocation named food cue induced craving before each stimulation.
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The intensity of the stimulator is set at 80% of resting motor threshold (RMT), and the other parameters are set to triplet 50Hz bursts, repeat at 5Hz, 2s seconds on and 8 seconds off, 1800 pulses per session, total duration of 9 minutes and 52 seconds.
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Фальшивый компаратор: Sham stimulation
The participants in sham stimulation will receive sham coil stimulation for 10 consecutive days and 3 times per day.
There will have at least 50 minutes interval between each intervention.
Participants will be undertaking symptom provocation named food cue induced craving before each stimulation.
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The same procedure will be performed in sham coil induced acoustic and scalp sensations similar to those induced by the active coil, but without electromagnetic penetration into the brain and without neural activation.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Change in BMI
Временное ограничение: Change in BMI between baseline and the end of the treatment (day 12) and follow-up (day 42)
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Unit of measure: BMI in kg/m^2 (weight in kilograms, height in meters)
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Change in BMI between baseline and the end of the treatment (day 12) and follow-up (day 42)
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Change in body weight
Временное ограничение: Change in body weight between baseline and the end of the treatment (day 12) and follow-up (day 42)
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Change in body weight (kg) from baseline to Day 12 (end of treatment) and to Day 42 (follow-up), to evaluate the effectiveness of dTMS in reducing antipsychotic-induced weight gain.
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Change in body weight between baseline and the end of the treatment (day 12) and follow-up (day 42)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Three Factor Eating Questionnaire (TFEQ)
Временное ограничение: Change in TFEQ between baseline and the end of the treatment (day 12) and follow-up (day 42)
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The Food Cravings Questionnaire-Trait (FCQ-T) is a self-reported measures which is a 39-item questionnaire that has nine subscales: intentions and plans to consume food, outcome expectancy of positive reinforcement, outcome expectancy of relief from negative states, anticipated lack of overeating control, preoccupation with food, physiological deficits and responses which may elicit craving, emotions experienced during food craving, external and internal cues that trigger cravings, and guilt.
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Change in TFEQ between baseline and the end of the treatment (day 12) and follow-up (day 42)
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Change in Food Cravings Questionnaire-Trait (FCQ-T)
Временное ограничение: Change in FCQ-T between baseline and the end of the treatment (day 12) and follow-up (day 42)
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The change of food craving will be evaluated by Food Cravings Questionnaire-Trait (FCQ-T), a self-report multidimensional questionnaire composed of 39 items aimed to investigate food addiction and eating disorders.
Total FCQ-T score will be used as a general measure of trait craving; individual FCQ-T scores related to the 9 measured craving dimensions could be useful in identifying and differentiating craving profiles between specific populations.
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Change in FCQ-T between baseline and the end of the treatment (day 12) and follow-up (day 42)
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Change in Food Craving Questionnaire State (FCQ-S)
Временное ограничение: Change in FCQ-S between baseline and the end of the treatment (day 12) and follow-up (day 42)
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The Food Craving Questionnaire-State (FCQ-S) is a 15-item self-report measure to assess momentary, state-dependent food craving.
The instrument consists of five multidimensional subscales: (1) intense desire to eat, (2) anticipation of positive reinforcement from eating, (3) anticipation of relief from negative states and feelings as a result of eating, (4) lack of control over eating, and (5) craving as a physiological state.
Respondents rate each item on a 5-point Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree").
Total scores are calculated by summing all 15 item responses, yielding a possible range of 15 to 75.
Higher total scores indicate more intense current state food cravings.
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Change in FCQ-S between baseline and the end of the treatment (day 12) and follow-up (day 42)
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Change of Visual Analogue Scale, VAS
Временное ограничение: Change in VAS between each food cue induced craving and food cue reactivity before and after
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The VAS is a simple, quick-to-administer, and sensitive instrument for detecting acute fluctuations in food craving, hunger, and related motivational states in response to food cue exposure.
In the context of food cue reactivity, the VAS is administered immediately before and after presentation of food stimuli (e.g., pictorial food cues, actual food exposure, or virtual reality food environments) to capture acute changes in craving, hunger, appetite, and related motivational states.
The VAS consists of a 100-mm horizontal line anchored at each end by verbal descriptors representing the extremes of the construct being measured, typically ranging from 0 ("not at all" or "no desire at all") to 100 ("extremely" or "very strong desire").The score is determined by measuring the distance in millimeters from the left anchor to the respondent's mark, yielding a possible range of 0 to 100, with higher scores indicating greater intensity of the measured construct.
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Change in VAS between each food cue induced craving and food cue reactivity before and after
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Change in parameters of the Stop Signal Task, SST
Временное ограничение: Change in parameters of SST between baseline and the end of the treatment (day 12) and follow-up (day 42)
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The SST aims to access cognitive behavioral inhibition control.
The study employed a task that comprised randomly interleaved NoGo and Stop-Signal trials to examine both types of inhibition.
The study measured six behavioral parameters of interest: namely Mean Go reaction time (GoRT), Stop-Signal mean reaction time (SSRT), Stop-Signal delay (SSD), Target accuracy, Go trial accuracy, and NoGo Accuracy.
The primary outcome measure derived from the SST is the stop-signal reaction time (SSRT) , which is an estimated measure of the speed of the inhibitory process.
The SSRT is calculated by subtracting the mean or median stop-signal delay (SSD) from the mean or median reaction time on go trials.
Higher SSRT values indicate longer inhibition latency and thus poorer inhibitory control, whereas lower SSRT values indicate faster inhibition and better inhibitory control.
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Change in parameters of SST between baseline and the end of the treatment (day 12) and follow-up (day 42)
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Change in parameters of the Go/No-Go Task (GNG)
Временное ограничение: Change in parameters of GNG between baseline and the end of the treatment (day 12) and follow-up (day 42)
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The Go/No-Go Task (GNG) is a computerized behavioral paradigm that measures response inhibition-specifically, the ability to withhold a prepotent motor response to a frequently occurring stimulus when an infrequent, conflicting stimulus occurs.The GNG task comprises two types of trials presented in random order: Go trials (typically 70-80% of all trials) and No-Go trials (typically 20-30% of all trials).The most critical outcome derived from the GNG task is the No-Go error rate, calculated as the number of incorrect responses on No-Go trials divided by the total number of No-Go trials.
Higher No-Go error rates indicate poorer inhibitory control.
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Change in parameters of GNG between baseline and the end of the treatment (day 12) and follow-up (day 42)
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Change in Blood laboratory parameters
Временное ограничение: Change in Blood laboratory parameters between baseline and the end of the treatment (day 12) and follow-up (day 42)
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About 20ml blood samples were collected intravenously to test blood routine, liver and kidney function, electrolytes and other routine tests.
Changes in lipid metabolism will be evaluated by Cholesterol (mg/dL), Triglycerides (mg/dL), High-Density Lipoprotein Cholesterol (mg/dL), Low-Density Lipoprotein Cholesterol (mg/dL), Fasting Blood Glucose (mmol/L).
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Change in Blood laboratory parameters between baseline and the end of the treatment (day 12) and follow-up (day 42)
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Change in correlation of fMRI and EEG functional connectivity
Временное ограничение: Change in correlation of fMRI and EEG functional connectivity between baseline and the end of the treatment (day 12) and follow-up (day 42)
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Examines how brain connectivity patterns measured by fMRI (blood-flow activity) relate to connectivity patterns measured by EEG (electrical activity).
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Change in correlation of fMRI and EEG functional connectivity between baseline and the end of the treatment (day 12) and follow-up (day 42)
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Change in abdominal and hip circumference
Временное ограничение: Change in abdominal and hip circumference between baseline and the end of the treatment (day 12) and follow-up (day 42)
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The Change in abdominal and hip circumference absolute values (cm) will be measured at baseline and the end of the treatment (day 12) and follow-up (day 42) to evaluate weight-related treatment responses of dTMS.
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Change in abdominal and hip circumference between baseline and the end of the treatment (day 12) and follow-up (day 42)
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
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 мая 2027 г.
Завершение исследования (Оцененный)
1 июня 2027 г.
Даты регистрации исследования
Первый отправленный
26 августа 2026 г.
Впервые представлено, что соответствует критериям контроля качества
26 августа 2026 г.
Первый опубликованный (Действительный)
31 августа 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
4 сентября 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
1 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
- LYEC2026-0195-Study B
- 82571770 (Другой номер гранта/финансирования: National Natural Science Foundation of China)
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. .