The Safety and Effectiveness of dTMS for Reducing Antipsychotic-induced Weight Gain (dTMS)
2026年9月1日 更新者：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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
60
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Ping Shao
- 電話番号：+86-13755112445
- メール：shp97jw@163.com
研究連絡先のバックアップ
- 名前：Renrong Wu
- 電話番号：+86-15874179855
- メール：wurenrong@csu.edu.cn
研究場所
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Hunan
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Changsha、Hunan、中国、410011
- The Second Xiangya Hospital of Central South University
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コンタクト：
- KaHei Chan
- 電話番号：+86-18890384723
- メール：heimradchan@foxmail.com
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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偽コンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in BMI
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Three Factor Eating Questionnaire (TFEQ)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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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ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2027年5月1日
研究の完了 (推定)
2027年6月1日
試験登録日
最初に提出
2026年8月26日
QC基準を満たした最初の提出物
2026年8月26日
最初の投稿 (実際)
2026年8月31日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月4日
QC基準を満たした最後の更新が送信されました
2026年9月1日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- LYEC2026-0195-Study B
- 82571770 (その他の助成金/資金番号：National Natural Science Foundation of China)
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いいえ
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