Investigating the Efficacy and Mechanisms of Individualized tACS Targeting Anhedonia in Late-Life Depression
Efficacy and Mechanisms of Personalized tACS Targeting Anhedonia in Late-Life Depression
調査の概要
状態
詳細な説明
This project aims to explore effective treatment strategies and mechanisms of action for personalized transcranial alternating current stimulation (tACS) targeting anhedonia in late-life depression (LLD). Late-life depression has a high prevalence, with 70% of patients exhibiting symptoms of anhedonia, which is
. Current pharmacological treatments face challenges such as poor response rates and significant side effects, creating an urgent need for novel intervention strategies. As a non-invasive neurostimulation technique, tACS can improve depressive symptoms by modulating brain oscillatory activity; however, personalized treatment protocols and mechanisms specifically targeting anhedonia in LLD remain unclear. By optimizing tACS parameters, validating clinical efficacy, and elucidating the underlying neural mechanisms, this project will fill a research gap in this field. The findings will not only provide safe and effective non-pharmacological treatment options for patients with geriatric depression, thereby reducing suicide risk, but will also advance the application of tACS technology in precision medicine for mental disorders, holding significant clinical value and social implications.
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：Daliang Sun Da liang Sun, Doctor
- 電話番号：+86 88188876
- メール：474929588@qq.com
研究場所
-
-
Tianjin Municipality
-
Tianjin、Tianjin Municipality、中国、300222
- 募集
- Tianjin Anding Hospital
-
コンタクト：
- Daliang Sun, Doctor
- 電話番号：+86 88188876
- メール：474929588@qq.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- (1) Patients were interviewed using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) - Clinical Version (SCID-5-CV) to confirm that they met the DSM-5 diagnostic criteria for "major depressive disorder"; (2) Age ≥ 60 years; gender not restricted; (3) Hamilton Depression Scale (HAMD)-17 score > 24
Exclusion Criteria:
- (1) History of severe head trauma or serious neurological conditions such as epilepsy; (2) Any brain devices or implants, including cochlear implants and aneurysm clips; treatments such as transcranial direct current stimulation (tDCS).
(3) Individuals who have undergone other physical modulation therapies within the past 8 weeks, including but not limited to non-convulsive electroconvulsive therapy, repetitive transcranial magnetic stimulation, and transcranial direct current stimulation.
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：active
The peak-to-peak amplitude was 1 mA at 40 Hz (tACS), with a frequency and a sinusoidal stimulation waveform.
The stimulation sites were located in the prefrontal cortex (F3 and F4) based on the 10-20 international EEG electrode placement system, with CZ serving as the return electrode.
|
divided into a real-stimulus group and a sham-stimulus group
|
|
偽コンパレータ：shame
The peak-to-peak amplitude was 1 mA at 40 Hz (tACS), with a frequency and a sinusoidal stimulation waveform.
The stimulation sites were located in the prefrontal cortex (F3 and F4) based on the 10-20 international EEG electrode placement system, with CZ serving as the return electrode, shame arm is not biologically active.
|
The sham tACS group received 40 Hz tACS with a peak-to-peak amplitude of 1 mA, a frequency of y, and a sinusoidal waveform.
The stimulation sites were located in the prefrontal cortex (F3 and F4) based on the 10-20 system of international EEG electrode placement, with CZ serving as the return electrode, which did not generate stimulation pulses.
|
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 |
|---|---|---|
|
Dimensional Anhedonia Rating Scale (DARS)
時間枠：12 week
|
The Dimensional Anhedonia Rating Scale (DARS) assesses the degree of anhedonia in patients.
|
12 week
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hamilton Depression Scale，HAMD -17
時間枠：12 week
|
The severity of a patient's depressive symptoms is assessed using the Hamilton Depression Scale (HAMD)-17.
This scale consists of 17 items that comprehensively evaluate a patient's depressive symptoms; the higher the score, the more severe the depressive symptoms.
|
12 week
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- tACS-MDD
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。