Closed-loop tTIS Targeted of the Nac as an Intervention for MUD Patients
31 августа 2026 г. обновлено: Shanghai Mental Health Center
Closed-loop Transcranial Temporal Interference Stimulation Targeted of the Nucleus Accumbens as an Intervention for Methamphetamine Use Disorder Patients
Closed-loop transcranial temporal interference stimulation (tTIS) targeting the nucleus accumbens may modulate abnormal neural responses to drug-related cues in individuals with methamphetamine use disorder (MUD), thereby reducing drug craving and improving cognitive and behavioral control.
Stimulation will be delivered in real time according to each patient's cue-induced response time.
Обзор исследования
Статус
Еще не набирают
Вмешательство/лечение
Подробное описание
This project will recruit individuals with methamphetamine use disorder. Participants will receive closed-loop transcranial temporal interference stimulation targeting the nucleus accumbens once daily for five consecutive days. During each intervention session, participants will be exposed to methamphetamine-related cues, and stimulation will be triggered according to their response time.
Before and after the intervention, clinical questionnaires and behavioral tasks will be administered to evaluate changes in drug craving, methamphetamine-use-related symptoms, inhibitory control, and reward-related decision-making. Cue-induced neural responses will also be assessed to investigate the neural mechanisms through which closed-loop tTIS targeting the nucleus accumbens may alleviate craving and improve addiction-related cognitive and behavioral dysfunction.
Тип исследования
Интервенционный
Регистрация (Оцененный)
50
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: Min Zhao, PhD
- Номер телефона: 64387250
- Электронная почта: drminzhao@gmail.com
Учебное резервное копирование контактов
- Имя: Tianzhen Chen, PhD
- Электронная почта: vomchan@hotmail.com
Места учебы
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Китай, 200030
- Shanghai Mental Health Center
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Контакт:
- Min Zhao, Phd
- Номер телефона: 64387250 18017311005
- Электронная почта: drminzhao@smhc.org.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:
- Individuals aged between 18 and 55 years, irrespective of gender, having completed a minimum of 9 years of education and capable of effectively cooperating in questionnaire evaluations.
- Meet the diagnostic criteria set forth by the DSM-V concerning the amphetamine-type substance addiction.
- A history of utilizing amphetamine-type substances for a duration not less than one year, with a frequency of use being at least once per week.
- Consent to actively cooperate in the completion of subsequent follow-up assessments.
Exclusion Criteria:
- Severe cognitive functional impairments manifested through a history of head trauma, cerebrovascular diseases, epilepsy, etc., or usage of cognitive enhancement drugs in the past 6 months; an intellectual disability with an IQ score less than 70.
- A diagnosis of schizophrenia or other severe mental illnesses as per the DSM-5 criteria.
- Abuse or dependence on other psychoactive substances (excluding nicotine) within the past 5 years.
- Severe organic diseases that might compromise study participation.
- Contraindications to cTBS, such as a history of epileptic seizures or the presence of metallic implants in proximity to the head.
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: Тройной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Фальшивый компаратор: Контрольная группа
Параметры стимуляции, включая частоту, силу тока и продолжительность, идентичны параметрам в активной группе.
Однако на устройстве активирован режим фиктивной стимуляции, в результате чего во время стимуляции фактический ток не подаётся.
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The stimulation parameters-including frequency, current intensity, and duration-are identical to those in the active group.
However, the sham stimulation mode is activated on the device, resulting in consist of a 5-s current ramp-up, but 0 s of continuous stimulation during the stimulation.
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Экспериментальный: Temporal Interference Stimulation Group
The first pair of electrodes continuously delivers a current at a frequency of f1 = 2 kHz, while the second pair delivers a current at f2 = 2.130 kHz.
Based on the principle of temporal interference, an alternating electric field at a frequency of f1 - f2 = 130 Hz is generated in the target region.
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Each session will comprise 240 trials, during which stimulation may be triggered up to 10 times according to the participant's cue-reactivity state.
Each stimulation will consist of a 5-s current ramp-up, 30 s of continuous stimulation, and a 5-s current ramp-down.
The intervention will be administered once daily for five consecutive days.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Change of Craving
Временное ограничение: baseline, 1 day after treatment, 1 month after treatment
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Visual Analog Scale, range0-100 point.
the higher the score, the more one wants drugs.
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baseline, 1 day after treatment, 1 month after treatment
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Obsessive-Compulsive Drug Use Scale score
Временное ограничение: baseline, 1 day after treatment, 1 month after treatment
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Drug-related obsessive thoughts and compulsive behaviours will be assessed using the Obsessive-Compulsive Drug Use Scale (OCDUS).
The scale consists of 14 items rated from 0 to 4, producing a total score ranging from 0 to 56.
Higher scores indicate more severe drug-related obsessive thoughts, craving, and impaired control over drug use.
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baseline, 1 day after treatment, 1 month after treatment
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Dual-Mode of Self-Control Scale-Impulsive System score
Временное ограничение: baseline, 1 day after treatment, 1 month after treatment
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Impulsive tendencies will be assessed using the Impulsive System subscale of the Dual-Mode of Self-Control Scale (DMSC-S).
The subscale contains 12 items rated from 1 to 5, producing a total score ranging from 12 to 60. Higher scores indicate stronger impulsive-system tendencies, including greater impulsivity, distractibility, and preference for immediate gratification.
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baseline, 1 day after treatment, 1 month after treatment
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Dual-Mode of Self-Control Scale-Control System score
Временное ограничение: baseline, 1 day after treatment, 1 month after treatment
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Self-control will be assessed using the Control System subscale of the Dual-Mode of Self-Control Scale (DMSC-S).
The subscale contains 9 items rated from 1 to 5, producing a total score ranging from 9 to 45. Higher scores indicate stronger self-control, including better problem-solving and future-oriented planning.
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baseline, 1 day after treatment, 1 month after treatment
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Stop Single Task
Временное ограничение: baseline, 1 day after treatment, 1 month after treatment
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Response inhibition will be assessed using the Stop-Signal Task.
The primary behavioural parameter will be the reaction time and accuracy, measured in milliseconds.
A longer stop-signal reaction time indicates poorer inhibitory control, whereas a shorter stop-signal reaction time indicates better inhibitory control.
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baseline, 1 day after treatment, 1 month after treatment
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EEG ERP amplitude during the Stop-Signal Task
Временное ограничение: baseline, 1 day after treatment, 1 month after treatment
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The mean amplitude of the stop-related event-related potential and functional connection will be measured in microvolts over frontocentral electrodes within the prespecified post-stimulus time window.
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baseline, 1 day after treatment, 1 month after treatment
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Decision-making Preferences and Delay of Gratification
Временное ограничение: baseline, 1 day after treatment, 1 month after treatment
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delay discounting task,Delay of gratification will be assessed using a computerised delay-discounting task in which participants choose between smaller immediate rewards and larger delayed rewards.
The discounting-rate parameter, k, will be estimated from participants' choices.
A higher k value indicates steeper delay discounting, a stronger preference for immediate rewards, and a lower ability to delay gratification.
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baseline, 1 day after treatment, 1 month after treatment
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Changes in Reward Learning
Временное ограничение: baseline, 1 day after treatment, 1 month after treatment
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Reward learning will be assessed using a computerised reinforcement-learning task.
A computational reinforcement-learning model will be fitted to participants' trial-by-trial choices.
The learning-rate parameter, alpha, ranges from 0 to 1 and represents the extent to which recent feedback is used to update expected values.
Higher values indicate greater updating in response to recent feedback.
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baseline, 1 day after treatment, 1 month after treatment
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sensitivity to reward and punishment
Временное ограничение: baseline, 1 day after treatment, 1 month after treatment
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Sensitivity to punishment will be assessed using the Sensitivity to Punishment subscale of the Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ).
The subscale contains 24 dichotomous items scored 0 or 1, producing a score ranging from 0 to 24.
Higher scores indicate greater sensitivity to punishment.
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baseline, 1 day after treatment, 1 month after treatment
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Behavioral Inhibition/Activation System Scale
Временное ограничение: baseline, 1 day after treatment, 1 month after treatment
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Sensitivity to anticipated punishment will be assessed using the 7-item Behavioural Inhibition System subscale of the Behavioural Inhibition System/Behavioural Activation System Scales.
Each item is rated from 1 to 4, producing a score ranging from 7 to 28.
Higher scores indicate greater behavioural inhibition and sensitivity to anticipated punishment.
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baseline, 1 day after treatment, 1 month after treatment
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Beck Depression Inventory-II score
Временное ограничение: baseline, 1 day after treatment, 1 month after treatment
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Depressive symptom severity will be assessed using the Beck Depression Inventory-II (BDI-II).
The inventory consists of 21 items rated from 0 to 3, producing a total score ranging from 0 to 63.
Higher scores indicate more severe depressive symptoms.
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baseline, 1 day after treatment, 1 month after treatment
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Drug-cue Flanker task
Временное ограничение: baseline, 1 day after treatment, 1 month after treatment
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Attentional interference from methamphetamine-related cues will be assessed using a computerised drug-cue Flanker task.
The drug-cue attentional interference effect will be calculated as the difference in mean reaction time between trials containing methamphetamine-related cues and trials containing neutral cues, measured in milliseconds.
A larger positive value indicates greater attentional interference from methamphetamine-related cues.
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baseline, 1 day after treatment, 1 month after treatment
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EEG theta power
Временное ограничение: baseline, 1 day after treatment, 1 month after treatment
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Theta-band power will be quantified within the prespecified frequency range, electrode region, and post-stimulus time window.
The cue-related theta effect will be calculated as the difference between methamphetamine-related and neutral cue conditions.
A larger value indicates a stronger theta-band response to methamphetamine-related cues.
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baseline, 1 day after treatment, 1 month after treatment
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EEG P3 amplitude
Временное ограничение: baseline, 1 day after treatment, 1 month after treatment
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Task-related electroencephalography will be recorded during the drug-cue Flanker task and the reward learning task.
The mean amplitude of the P3 event-related potential will be measured in microvolts within the prespecified electrode region and post-stimulus time window.
A larger positive difference indicates greater neural reactivity to methamphetamine-related cues.
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baseline, 1 day after treatment, 1 month after treatment
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Учебный стул: Min Zhao, PhD, Shanghai Mental Health Center
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 2026 г.
Завершение исследования (Оцененный)
1 ноября 2026 г.
Даты регистрации исследования
Первый отправленный
30 июля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
31 августа 2026 г.
Первый опубликованный (Действительный)
3 сентября 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
3 сентября 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
31 августа 2026 г.
Последняя проверка
1 июля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- MZhao-029
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. .