Temporal Interference Transcranial Alternating Current Stimulation for Major Depressive Disorder
A Double-Blind, Randomized, Sham-Controlled Clinical Trial of Temporal Interference Transcranial Alternating Current Stimulation for the Treatment of Major Depressive Disorder
This multi-center, double-blind study, randomized controlled trial aims to evaluate the efficacy and safety of Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) in patients with major depressive disorder (MDD)
Participants with major depressive disorder will be randomized to receive high-frequency TI-tACS(130 Hz), low-frequency TI-tACS(2Hz), or sham stimulation targeting the right amygdala.
The intervention consists of 20 stimulation sessions administered over 2 weeks (twice a day for 5 consecutive days, followed by a 2-day break, and another 5 consecutive days). Clinical assessments will be conducted at baseline, during treatment, and at multiple follow-up time points up to 6 months.
The primary outcome for MDD is the change from baseline in the Hamilton Depression Rating Scale (HAMD-17) at week 2. Secondary outcomes include changes in clinical symptoms, cognitive function, and safety profiles.
調査の概要
状態
条件
詳細な説明
Major depressive disorder (MDD) is a highly prevalent psychiatric disorder associated with substantial disability and impaired quality of life. Neuroimaging studies have demonstrated abnormalities in distributed cortical-subcortical circuits, particularly involving the amygdala, which plays a central role in emotional processing and symptom regulation. Although several neuromodulation techniques have shown therapeutic potential, currently available approaches have limited ability to selectively modulate deep brain structures without invasive procedures.
Temporal interference transcranial alternating current stimulation (TI-tACS) is a novel non-invasive neuromodulation technique that delivers two high-frequency alternating currents with slightly different frequencies to generate a low-frequency envelope within deep brain regions. This approach enables selective modulation of deep neural structures, such as the amygdala, while minimizing stimulation of the overlying cortex.
This is a multicenter, randomized, triple-blind, sham-controlled clinical trial designed to evaluate the efficacy, safety, and neurobiological mechanisms of TI-tACS in participants with MDD. Participants will be enrolled randomized to receive active or sham TI-tACS according to the study protocol.
Approximately 102 participants will be recruited. Following written informed consent, participants will undergo baseline assessments and subsequent study evaluations according to the protocol. Study assessments include clinical evaluations, neurocognitive testing, electroencephalography (EEG), magnetic resonance imaging (MRI), and biological sample collection. TI-tACS treatment consists of 20 stimulation sessions administered over two weeks (two sessions per day for five consecutive days, followed by a two-day break, and another five consecutive treatment days).
Participants will also complete scheduled post-treatment follow-up assessments to evaluate the persistence of treatment effects and the long-term safety of TI-tACS.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Yumeng Ju( Associate Researcher), PhD
- 電話番号：86+18100731091
- メール：yumeng.ju@csu.edu.cn
研究連絡先のバックアップ
- 名前：Lingsi Zeng, PhD Candidate
- メール：zenglsi@163.com
参加基準
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
説明
Inclusion Criteria:
- Age between 18 and 55 years (inclusive), any gender;
- Diagnosis of a single or recurrent episode of Major Depressive Disorder (MDD) according to DSM-5 criteria, assessed by trained researchers using the Structured Clinical Interview for DSM-5 (SCID), without psychotic features;
- HAMD-17 score ≥14; inadequate response to stable, regular antidepressant medication for at least 1 month at an adequate dose;
- Education level: junior high school or above; adequate cognitive and language ability to understand and complete study assessments;
- Voluntary participation with signed informed consent; ability to comply with study visits, treatment schedules, laboratory tests, and other study procedures.
Exclusion Criteria:
- History of psychiatric disorders other than MDD;
- Pregnancy or lactation;
- Neurologic disorders or serious systemic diseases (e.g., thyroid disease, lupus erythematosus, diabetes, hepatic or renal impairment, active infection, major trauma);
- History of significant head injury or coma
- Receipt of physical therapies such as electroconvulsive therapy or rTMS within the past six months before enrollment
- Suspected or confirmed history of alcohol or substance dependence;
- Current severe suicidal ideation or recent suicide attempt;
- Current participation in another clinical trial or recent use of prohibited psychotropic medications;
- Positive urine drug screening or abnormal thyroid function tests;
- Contraindications to magnetic resonance imaging (MRI) or electroencephalography (EEG);
- Inability to provide fully informed consent.
研究計画
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：High-frequency TI-tACS
Participants in the High-frequency TI-tACS group receive 20-minute temporal interference transcranial alternating current stimulation (130Hz) twice a day, delivered via two pairs of transcranial electrodes, targeting the right amygdala.
The stimulation is administered in 2 weeks, consisting of 5 consecutive treatment days, followed by a 2-day break, and then another 5 consecutive treatment days.
|
Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) is a non-invasive neuromodulation technique that generates a low-frequency （130HZ or 2HZ) envelope field in deep brain regions, particularly the right amygdala, through the interaction of two high-frequency currents.
他の名前：
|
|
実験的：Low-frequency TI-tACS
Participants in the Low-frequency TI-tACS group receive 20-minute temporal interference transcranial alternating current stimulation (2 Hz) twice a day, delivered via two pairs of transcranial electrodes, targeting the right amygdala.
The stimulation is administered in 2 weeks, consisting of 5 consecutive treatment days, followed by a 2-day break, and then another 5 consecutive treatment days.
|
Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) is a non-invasive neuromodulation technique that generates a low-frequency （130HZ or 2HZ) envelope field in deep brain regions, particularly the right amygdala, through the interaction of two high-frequency currents.
他の名前：
|
|
偽コンパレータ：Sham TI-tACS
Participants in the Sham TI-tACS group receive 20-minute sham stimulation of the same device twice a day for 5 consecutive treatment days, followed by a 2-day break, and then another 5 consecutive treatment days.
|
Sham Temporal Interference transcranial Alternating Current Stimulation will mimic the sensory experience of active stimulation without delivering effective current.
|
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 |
|---|---|---|
|
Change from baseline in the Hamilton Depression Rating Scale(HAMD-17) scores at week 2.
時間枠：2 weeks(from baseline)
|
The 17-item Hamilton Depression Rating Scale (HAMD-17) is a clinician-administered instrument used to assess the severity of depressive symptoms.
The scale consists of 17 items with a total score ranging from 0 to 52.
Higher scores indicate more severe depressive symptoms.
The primary outcome for MDD participants will be calculated as the change in HAMD-17 score from baseline to Week 2.
|
2 weeks(from baseline)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
時間枠：Baseline to month 2 follow-up(post treatment)
|
A 7-item self-report questionnaire used to assess the severity of generalized anxiety symptoms.
Total scores range from 0 to 21, with higher scores indicating greater anxiety severity.
|
Baseline to month 2 follow-up(post treatment)
|
|
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score
時間枠：Baseline to month 2 follow-up
|
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-administered instrument used to assess the severity of depressive symptoms and sensitivity to treatment-related changes.
The scale consists of 10 items with a total score ranging from 0 to 60. Higher scores indicate more severe depressive symptoms.
|
Baseline to month 2 follow-up
|
|
Adverse Events Related to treatment
時間枠：Baseline to month 2 follow-up
|
Incidence, type, and severity of adverse events related to the transcranial temporal interference stimulation, assessed using a standardized Neuromodulation Adverse Effects Questionnaire.
|
Baseline to month 2 follow-up
|
|
Change in Patient Health Questionnaire-9 (PHQ-9)
時間枠：Baseline to month 2 follow-up
|
A 9-item self-report questionnaire used to assess depressive symptom severity.
Total scores range from 0 to 27, with higher scores indicating greater depression severity.
|
Baseline to month 2 follow-up
|
|
Change in the Hamilton Anxiety Rating Scale (HAMA) Score
時間枠：Baseline to month 2 follow-up
|
The Hamilton Depression Rating Scale-17 (HAMD-17) is a 17-item clinician-administered scale used to assess the severity of depressive symptoms.
The total score ranges from 0 to 52, with higher scores indicating more severe depressive symptoms.
|
Baseline to month 2 follow-up
|
|
Change in Young Mania Rating Scale (YMRS) Score
時間枠：Baseline to month 2 follow-up
|
The Young Mania Rating Scale (YMRS) is an 11-item clinician-administered instrument used to assess the severity of manic symptoms and to monitor treatment-emergent mania or hypomania.
Total scores range from 0 to 60, with higher scores indicating more severe manic symptoms.
|
Baseline to month 2 follow-up
|
|
Change in Pittsburgh Sleep Quality Index (PSQI) Score
時間枠：Baseline to month 2 follow-up
|
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire used to assess subjective sleep quality and sleep disturbances over the previous month.
The questionnaire generates a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality.
|
Baseline to month 2 follow-up
|
|
Change in Beck Scale for Suicide Ideation (BSI) Score
時間枠：Baseline to month 2 follow-up
|
The Beck Scale for Suicide Ideation (BSI) is a 19-item clinician-administered instrument used to assess the severity of suicidal thoughts, attitudes, and intentions.
Total scores range from 0 to 38, with higher scores indicating more severe suicidal ideation.
|
Baseline to month 2 follow-up
|
|
hange in 10-item Connor-Davidson Resilience Scale (CD-RISC-10) Score
時間枠：Baseline to month 2 follow-up
|
The 10-item Connor-Davidson Resilience Scale (CD-RISC-10) is a 10-item self-report questionnaire used to assess psychological resilience and the ability to cope with adversity.
Total scores range from 0 to 40, with higher scores indicating greater psychological resilience.
|
Baseline to month 2 follow-up
|
|
Change in Chinese Version of the Cognitive Emotion Regulation Questionnaire (CERQ-C) Score
時間枠：Baseline to month 2 follow-up
|
The Chinese Version of the Cognitive Emotion Regulation Questionnaire (CERQ-C) is a 36-item self-report questionnaire used to assess cognitive emotion regulation strategies in response to stressful or negative life events.
Total scores range from 36 to 180, with higher scores indicating greater use of cognitive emotion regulation strategies.
|
Baseline to month 2 follow-up
|
|
Change in State Anxiety Inventory (S-AI) Score
時間枠：Baseline to month 2 follow-up
|
The State Anxiety Inventory (S-AI) is a 20-item self-report questionnaire used to assess transient anxiety experienced at the time of assessment.
Total scores range from 20 to 80, with higher scores indicating greater state anxiety.
|
Baseline to month 2 follow-up
|
|
Change in 17-item Hamilton Depression Rating Scale (HAMD-17) Score
時間枠：Baseline to month 2 follow-up
|
The 17-item Hamilton Depression Rating Scale (HAMD-17) is a 17-item clinician-administered instrument used to assess the severity of depressive symptoms.
Total scores range from 0 to 52, with higher scores indicating more severe depressive symptoms.
|
Baseline to month 2 follow-up
|
|
Change in Sheehan Disability Scale (SDS) Score
時間枠：Baseline to month 2 follow-up
|
he Sheehan Disability Scale (SDS) is a 3-item self-report questionnaire used to assess functional impairment in work/school, social life, and family life/home responsibilities.
Total scores range from 0 to 30, with higher scores indicating greater functional impairment.
|
Baseline to month 2 follow-up
|
|
Change in Snaith-Hamilton Pleasure Scale (SHAPS) Score
時間枠：Baseline to month 2 follow-up
|
The Snaith-Hamilton Pleasure Scale (SHAPS) is a 14-item self-report questionnaire used to assess anhedonia, or the ability to experience pleasure.
Total scores range from 14 to 56, with higher scores indicating greater anhedonia (reduced ability to experience pleasure).
|
Baseline to month 2 follow-up
|
|
Change in Ruminative Responses Scale (RRS) Score
時間枠：Baseline to month 2 follow-up
|
The Ruminative Responses Scale (RRS) is a 22-item self-report questionnaire used to assess the tendency to engage in repetitive negative thinking in response to depressed mood or distress.
Total scores range from 22 to 88, with higher scores indicating greater rumination.
|
Baseline to month 2 follow-up
|
協力者と研究者
スポンサー
協力者
捜査官
- スタディチェア：Yan Zhang, PhD、Second Xiangya Hospital of Central South University
- 主任研究者：Yumeng Ju, PhD、Second Xiangya Hospital of Central South University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- LYG20240121
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。