Individualized Temporal Interference Stimulation for Reward Processing in Late-Life Depression
Neural Mechanisms Underlying the Modulation of Reward Processing by Individualized Temporal Interference Stimulation Targeting the Nucleus Accumbens in Late-Life Depression
This study aims to investigate the effects and neural mechanisms of individualized temporal interference stimulation (TI) targeting the left nucleus accumbens in older adults with depression. A total of 70 participants aged 60-80 years will be randomly assigned to receive active TI or sham stimulation. Clinical and cognitive assessments, a probabilistic reversal learning (PRL) task, MRI, and TMS-EEG will be used to evaluate changes in depressive symptoms, reward processing, and brain activity. Clinical and cognitive follow-up assessments will be conducted at 1 and 4 weeks after the intervention.
Обзор исследования
Статус
Подробное описание
This is a randomized, double-blind, sham-controlled, parallel-group study involving 70 adults aged 60-80 years who meet DSM-5 criteria for a current episode of major depressive disorder and have at least moderate depressive symptoms.
Participants will be randomly assigned in a 1:1 ratio to an active TI group (n=35) or a sham stimulation group (n=35). Individualized TI will target the left nucleus accumbens, with stimulation administered for approximately 20 minutes per session, twice daily for five consecutive days (10 sessions in total).
Clinical and neuropsychological assessments will evaluate depressive symptoms, anxiety, anhedonia, sleep, and cognitive function. A probabilistic reversal learning (PRL) task will assess reward learning and cognitive flexibility. Structural MRI will support individualized stimulation planning, while resting-state functional MRI (rs-fMRI) and TMS-EEG will be used to investigate changes in brain networks and neurophysiological activity.
Assessments will be conducted at baseline and after the intervention, with additional follow-ups at 1 and 4 weeks. The study will compare changes between groups and explore associations among clinical outcomes, reward processing, and neural measures.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Dongmei Wang, Ph.D
- Номер телефона: +86 132 4190 1959
- Электронная почта: wangdm@psych.ac.cn
Места учебы
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Anhui
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Hefei, Anhui, Китай, 230022
- Hefei Fourth People's Hospital
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Контакт:
- Xiaoming Kong, M.D.
- Номер телефона: +86 13955118186
- Электронная почта: kxm186@163.com
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Контакт:
- Xiangyang Zhang
- Электронная почта: zhangxy99@mail.tsinghua.edu.cn
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Aged 60-80 years.
- Meet the DSM-5 diagnostic criteria for a current episode of major depressive disorder (MDD).
- Have at least moderate depressive symptoms.
- Able to understand and comply with study procedures, provide written informed consent, and voluntarily participate in the study.
Exclusion Criteria:
- History of severe neurological disorders or epilepsy.
- Severe or unstable medical conditions.
- Contraindications to MRI, transcranial magnetic stimulation (TMS), or transcranial electrical stimulation.
- Comorbid severe psychiatric disorders, such as bipolar disorder or schizophrenia.
- Significant cognitive impairment that interferes with informed consent or completion of study procedures.
- High suicide risk.
- Any other medical or safety condition that, in the investigator's judgment, makes participation inappropriate.
Учебный план
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: Active Temporal Interference Stimulation
Participants will receive individualized active temporal interference stimulation (TI) targeting the left nucleus accumbens, for 20 minutes per session, twice daily for five consecutive days (10 sessions in total). |
Individualized active temporal interference stimulation (TI) targeting the left nucleus accumbens, delivered for 20 minutes per session, twice daily for five consecutive days (10 sessions in total). |
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Фальшивый компаратор: Sham Temporal Interference Stimulation
Participants will receive sham temporal interference stimulation (TI) with similar electrode placement and procedures, following the same schedule as the active group (10 sessions over five days). |
Sham temporal interference stimulation (TI) with similar electrode placement and procedures, without sustained effective stimulation, following the same schedule as the active group (10 sessions over five days). |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Hamilton Depression Rating Scale (HAMD-24)
Временное ограничение: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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The 24-item Hamilton Depression Rating Scale (HAMD-24) assesses depressive symptom severity. Total scores range from 0 to 76, with higher scores indicating more severe depressive symptoms. |
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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Snaith-Hamilton Pleasure Scale (SHAPS)
Временное ограничение: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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Anhedonia will be assessed using the 14-item Snaith-Hamilton Pleasure Scale (SHAPS). Total scores range from 14 to 56, with higher scores indicating more severe anhedonia. Changes from baseline will be compared between groups. |
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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Probabilistic Reversal Learning (PRL) Task
Временное ограничение: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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The PRL task assesses reward-based learning and cognitive flexibility. Participants learn from probabilistic feedback and adjust their choices when reward contingencies change. Task performance will be evaluated using behavioral measures of reward learning and reversal learning. |
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Hamilton Anxiety Rating Scale (HAMA)
Временное ограничение: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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Anxiety severity will be assessed using the 14-item HAMA. Total scores range from 0 to 56, with higher scores indicating more severe anxiety. |
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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Pittsburgh Sleep Quality Index (PSQI)
Временное ограничение: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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The Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality and disturbances. The global score, calculated from seven components, ranges from 0 to 21, with higher scores indicating poorer sleep quality. |
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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Mini-Mental State Examination (MMSE)
Временное ограничение: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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Global cognitive function will be assessed using the MMSE. Total scores range from 0 to 30, with higher scores indicating better cognitive function. |
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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Auditory Verbal Learning Test (AVLT) Performance
Временное ограничение: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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Verbal learning and memory will be evaluated using the numbers of correctly recalled words during immediate recall, delayed recall, category-cued recall, and recognition testing. |
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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Verbal Fluency Test (VF) Performance
Временное ограничение: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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Verbal fluency will be assessed using the numbers of valid responses generated during animal naming, phonemic word generation, and action fluency tasks, each lasting one minute. |
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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3D Confusion Assessment Method (3D-CAM)
Временное ограничение: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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Delirium will be assessed using the 3-Minute Diagnostic Interview for CAM-Defined Delirium (3D-CAM). The outcome will be recorded as the presence or absence of delirium. |
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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Clock Drawing Test (CDT)
Временное ограничение: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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Visuospatial and executive functioning will be assessed using a four-point Clock Drawing Test. Scores range from 0 to 4, with higher scores indicating better performance. |
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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Digit Span Test (DST) Performance
Временное ограничение: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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Attention and working memory will be assessed using forward and backward digit span, including maximum correctly recalled span length and the number of correct sequences. |
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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Trail Making Test (TMT)
Временное ограничение: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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Processing speed, attention, and executive functioning will be evaluated using completion time in seconds across the four TMT conditions in the study protocol. Errors will also be recorded. |
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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Neuropsychiatric Inventory (NPI)
Временное ограничение: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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The 12-domain Neuropsychiatric Inventory (NPI) assesses neuropsychiatric symptoms. The total score is calculated by summing frequency × severity scores across 12 domains and ranges from 0 to 144, with higher scores indicating more severe symptoms. |
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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Activities of Daily Living (ADL)
Временное ограничение: Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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Daily functioning will be assessed using the 20-item ADL scale. Scores range from 20 to 80, with higher scores indicating greater functional impairment. |
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
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Resting-State fMRI Brain Network Measures
Временное ограничение: Baseline, immediately after the intervention
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Resting-state fMRI will be used to evaluate changes in nucleus accumbens-related functional connectivity and brain network characteristics following the intervention. |
Baseline, immediately after the intervention
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TMS-Evoked Global Mean Field Amplitude (GMFA)
Временное ограничение: Baseline, immediately after the intervention
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Global mean field amplitude (GMFA) will be calculated from TMS-evoked EEG recordings to quantify the overall cortical response to stimulation. Changes in GMFA amplitude will be assessed. |
Baseline, immediately after the intervention
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TMS-EEG Time-Frequency Power
Временное ограничение: Baseline, immediately after the intervention
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Time-frequency analysis of TMS-EEG recordings will be used to assess changes in oscillatory power across frequency bands following stimulation. |
Baseline, immediately after the intervention
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TMS-EEG Functional Connectivity
Временное ограничение: Baseline, immediately after the intervention
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Functional connectivity will be assessed using TMS-EEG recordings to evaluate changes in the synchronization and interaction of cortical brain regions. |
Baseline, immediately after the intervention
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TMS-EEG Source-Localized Cortical Activity
Временное ограничение: Baseline, immediately after the intervention
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EEG source reconstruction will be used to estimate changes in TMS-evoked cortical activity at the source level. |
Baseline, immediately after the intervention
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TMS-Evoked Potential (TEP) Amplitude
Временное ограничение: Baseline, immediately after the intervention
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TMS-evoked potentials (TEPs) will be analyzed to assess changes in cortical responses, including the amplitude of TMS-evoked EEG components. |
Baseline, immediately after the intervention
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Xiangyang Zhang, Ph.D, Tsinghua University
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CASPsy13
Планирование данных отдельных участников (IPD)
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Описание плана IPD
The datasets generated and/or analyzed during the current study are not publicly available due to ethical restrictions (as they contain information that could compromise participant privacy), but will be available from the corresponding author upon reasonable request after completion of the study and approval by the ethics committee.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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. .