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Efficacy and Safety of Transcranial Temporal Interference Stimulation for Depression

2026年5月27日 更新者：Yonggui Yuan

The goal of this clinical trial is to learn whether transcranial temporal interference stimulation (tTIS) can help treat major depressive disorder (MDD) in adults. The study will also learn about the safety of tTIS and explore how it may affect brain structure and brain function.

The main questions it aims to answer are whether active tTIS lowers depression symptom scores more than sham stimulation after treatment, and what medical problems or side effects participants have during or after tTIS.

Researchers will compare active tTIS targeting the left anterior limb of the internal capsule, active tTIS targeting the left subgenual anterior cingulate cortex, and sham stimulation. Sham stimulation is designed to feel similar to real stimulation but does not provide the same active treatment.

Participants with MDD will be randomly assigned to one of the three groups. They will receive two 20-minute treatment sessions each day for 5 days. They will complete depression, anxiety, pleasure, psychosomatic symptom, and safety assessments before treatment, after treatment, and during follow-up. They will also have brain magnetic resonance imaging scans before and after treatment.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

Major depressive disorder (MDD) is a common and disabling mental disorder. Although medication, psychotherapy, and established brain stimulation methods can help many people with MDD, some participants still have insufficient improvement. Transcranial temporal interference stimulation (tTIS) is a non-invasive brain stimulation technique that may allow modulation of deeper brain regions or pathways. This study is designed to evaluate whether tTIS can improve depressive symptoms in adults with MDD, assess its safety, and explore potential neuroimaging mechanisms.

This is a single-center, randomized, double-blind, sham-controlled clinical trial conducted at Zhongda Hospital, Southeast University. Eligible participants with MDD will be randomly assigned in a 1:1:1 ratio to one of three groups: active tTIS targeting the left anterior limb of the internal capsule (ALIC), active tTIS targeting the left subgenual anterior cingulate cortex (sgACC), or sham tTIS. The sham stimulation will be designed to provide sensory feedback similar to active stimulation while maintaining blinding.

Participants with MDD will receive 10 treatment sessions over 5 consecutive days, with two 20-minute sessions each day. Clinical symptoms and safety will be assessed at baseline, after treatment, and during follow-up. The main clinical outcome is the change in the 24-item Hamilton Depression Rating Scale (HAMD-24) total score from baseline to after treatment. Secondary outcomes include follow-up changes in depressive symptoms, response and remission rates, anxiety symptoms, anhedonia, psychosomatic symptoms, side effects, and adverse events.

Multimodal 5.0T brain magnetic resonance imaging (MRI) will be collected from participants with MDD before and after treatment. MRI measures will include structural imaging, resting-state functional imaging, and diffusion imaging. These data will be used to explore changes in brain structure, functional connectivity, and diffusion-related measures after tTIS, and to identify potential imaging biomarkers related to treatment response.

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：Yue Zhou, MD Candidate
  • 電話番号：+86 15651003002
  • メール：2725106172@qq.com

研究連絡先のバックアップ

  • 名前：Yubo Zhang, MD Candidate
  • 電話番号：+86 18651617808
  • メール：1301053461@qq.com

研究場所

  • 中国
    • Jiangsu
      • Nanjing、Jiangsu、中国、210009
        • Zhongda Hospital Southeast University
        • コンタクト：
          • Yue Zhou, MD Candidate
          • 電話番号：+86 15651003002
          • メール：2725106172@qq.com
        • コンタクト：
          • Yubo Zhang, MD Candidate
          • 電話番号：+86 1865161780
          • メール：1301053461@qq.com
        • 主任研究者：
          • Yonggui Yuan, PhD

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
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Diagnosed with major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), by two independent psychiatrists
  • 24-item Hamilton Depression Rating Scale (HAMD-24) total score greater than 20 at baseline
  • Aged 18 to 65 years
  • Right-handed
  • Able to understand the study procedures and willing to provide written informed consent

Exclusion Criteria:

  • History of epilepsy, brain tumor, or brain trauma
  • Receipt of transcranial magnetic stimulation, transcranial electrical stimulation, or electroconvulsive therapy within the past 3 months
  • Presence of metal implants or other contraindications to transcranial electrical stimulation or magnetic resonance imaging
  • Acute or severe suicidal ideation
  • Any other condition judged by the investigators to make participation unsuitable for this study

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：トリプル

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 tTIS Targeting Left ALIC
Participants in this arm will receive active transcranial temporal interference stimulation (tTIS) targeting the left anterior limb of the internal capsule (ALIC). Treatment will be delivered twice daily for 5 consecutive days, with each session lasting 20 minutes and a 30-minute interval between sessions.
デバイス：Active Transcranial Temporal Interference Stimulation Targeting Left ALIC
Participants in this arm will receive active transcranial temporal interference stimulation (tTIS) targeting the left anterior limb of the internal capsule (ALIC). The stimulation target will be individualized based on each participant's magnetic resonance imaging data. The difference frequency will be 130 Hz. Each session will last 20 minutes, twice daily for 5 consecutive days, with a 30-minute interval between sessions.
他の名前：
  • Active tTIS Targeting Left ALIC
アクティブコンパレータ：Active tTIS Targeting Left sgACC
Participants in this arm will receive active transcranial temporal interference stimulation (tTIS) targeting the left subgenual anterior cingulate cortex (sgACC). Treatment will be delivered twice daily for 5 consecutive days, with each session lasting 20 minutes and a 30-minute interval between sessions.
デバイス：Active Transcranial Temporal Interference Stimulation Targeting Left sgACC
Participants in this arm will receive active transcranial temporal interference stimulation (tTIS) targeting the left subgenual anterior cingulate cortex (sgACC). The stimulation target will be individualized based on each participant's magnetic resonance imaging data. The difference frequency will be 130 Hz. Each session will last 20 minutes, twice daily for 5 consecutive days, with a 30-minute interval between sessions.
他の名前：
  • Active tTIS Targeting Left sgACC
偽コンパレータ：Sham tTIS
Participants in this arm will receive sham transcranial temporal interference stimulation (tTIS). Sham stimulation will be delivered using the same type of device and will provide sensory feedback similar to active stimulation, but it will not provide the same active treatment dose. Treatment sessions will follow the same schedule as the active stimulation arms.
デバイス：Sham Transcranial Temporal Interference Stimulation
Participants in this arm will receive sham transcranial temporal interference stimulation (tTIS) using the same type of device as active stimulation. Sham stimulation will provide sensory feedback similar to active stimulation to help maintain masking, but it will not deliver the same active treatment dose. Each session will last 20 minutes, twice daily for 5 consecutive days, with a 30-minute interval between sessions.
他の名前：
  • Sham tTIS

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 in 24-item Hamilton Depression Rating Scale (HAMD-24) Total Score From Baseline to Week 1
時間枠：Baseline and Week 1
The 24-item Hamilton Depression Rating Scale (HAMD-24) will be used to assess the severity of depressive symptoms. The total score ranges from 0 to 76, with higher scores indicating more severe depressive symptoms. The primary outcome is the change in HAMD-24 total score from baseline to Week 1.
Baseline and Week 1

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in 24-item Hamilton Depression Rating Scale (HAMD-24) Total Score From Baseline to Week 2
時間枠：Baseline and Week 2
The 24-item Hamilton Depression Rating Scale (HAMD-24) will be used to assess depressive symptoms. The total score ranges from 0 to 76, with higher scores indicating more severe depressive symptoms. This outcome measures the change in HAMD-24 total score from baseline to Week 2.
Baseline and Week 2
Change in 24-item Hamilton Depression Rating Scale (HAMD-24) Total Score From Baseline to Week 6
時間枠：Baseline and Week 6
The 24-item Hamilton Depression Rating Scale (HAMD-24) will be used to assess depressive symptoms. The total score ranges from 0 to 76, with higher scores indicating more severe depressive symptoms. This outcome measures the change in HAMD-24 total score from baseline to Week 6.
Baseline and Week 6
Remission Rate Based on the 24-item Hamilton Depression Rating Scale (HAMD-24) at Week 1
時間枠：Week 1
Remission is defined as a 24-item Hamilton Depression Rating Scale (HAMD-24) total score of 9 or lower. This outcome measures the proportion of participants who meet the remission criterion at Week 1.
Week 1
Remission Rate Based on the 24-item Hamilton Depression Rating Scale (HAMD-24) at Week 2
時間枠：Week 2
Remission is defined as a 24-item Hamilton Depression Rating Scale (HAMD-24) total score of 9 or lower. This outcome measures the proportion of participants who meet the remission criterion at Week 2.
Week 2
Remission Rate Based on the 24-item Hamilton Depression Rating Scale (HAMD-24) at Week 6
時間枠：Week 6
Remission is defined as a 24-item Hamilton Depression Rating Scale (HAMD-24) total score of 9 or lower. This outcome measures the proportion of participants who meet the remission criterion at Week 6.
Week 6
Response Rate Based on the 24-item Hamilton Depression Rating Scale (HAMD-24) at Week 1
時間枠：Baseline and Week 1
Response is defined as a reduction of at least 50% in the 24-item Hamilton Depression Rating Scale (HAMD-24) total score from baseline. This outcome measures the proportion of participants who meet the response criterion at Week 1.
Baseline and Week 1
Response Rate Based on the 24-item Hamilton Depression Rating Scale (HAMD-24) at Week 2
時間枠：Baseline and Week 2
Response is defined as a reduction of at least 50% in the 24-item Hamilton Depression Rating Scale (HAMD-24) total score from baseline. This outcome measures the proportion of participants who meet the response criterion at Week 2.
Baseline and Week 2
Response Rate Based on the 24-item Hamilton Depression Rating Scale (HAMD-24) at Week 6
時間枠：Baseline and Week 6
Response is defined as a reduction of at least 50% in the 24-item Hamilton Depression Rating Scale (HAMD-24) total score from baseline. This outcome measures the proportion of participants who meet the response criterion at Week 6.
Baseline and Week 6
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score From Baseline to Week 1
時間枠：Baseline and Week 1
The Hamilton Anxiety Rating Scale (HAMA) will be used to assess anxiety symptoms. The total score ranges from 0 to 56, with higher scores indicating more severe anxiety symptoms. This outcome measures the change in HAMA total score from baseline to Week 1.
Baseline and Week 1
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score From Baseline to Week 2
時間枠：Baseline and Week 2
The Hamilton Anxiety Rating Scale (HAMA) will be used to assess anxiety symptoms. The total score ranges from 0 to 56, with higher scores indicating more severe anxiety symptoms. This outcome measures the change in HAMA total score from baseline to Week 2.
Baseline and Week 2
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score From Baseline to Week 6
時間枠：Baseline and Week 6
The Hamilton Anxiety Rating Scale (HAMA) will be used to assess anxiety symptoms. The total score ranges from 0 to 56, with higher scores indicating more severe anxiety symptoms. This outcome measures the change in HAMA total score from baseline to Week 6.
Baseline and Week 6
Change in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score From Baseline to Week 1
時間枠：Baseline and Week 1
The Snaith-Hamilton Pleasure Scale (SHAPS) will be used to assess anhedonia. The total score ranges from 0 to 14, with higher scores indicating more severe anhedonia. This outcome measures the change in SHAPS total score from baseline to Week 1.
Baseline and Week 1
Change in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score From Baseline to Week 2
時間枠：Baseline and Week 2
The Snaith-Hamilton Pleasure Scale (SHAPS) will be used to assess anhedonia. The total score ranges from 0 to 14, with higher scores indicating more severe anhedonia. This outcome measures the change in SHAPS total score from baseline to Week 2.
Baseline and Week 2
Change in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score From Baseline to Week 6
時間枠：Baseline and Week 6
The Snaith-Hamilton Pleasure Scale (SHAPS) will be used to assess anhedonia. The total score ranges from 0 to 14, with higher scores indicating more severe anhedonia. This outcome measures the change in SHAPS total score from baseline to Week 6.
Baseline and Week 6
Change in Psychosomatic Symptoms Scale (PSSS) Total Score From Baseline to Week 1
時間枠：Baseline and Week 1
The Psychosomatic Symptoms Scale (PSSS) will be used to assess psychosomatic symptoms. Higher scores indicate more severe psychosomatic symptoms. This outcome measures the change in PSSS total score from baseline to Week 1.
Baseline and Week 1
Change in Psychosomatic Symptoms Scale (PSSS) Total Score From Baseline to Week 2
時間枠：Baseline and Week 2
The Psychosomatic Symptoms Scale (PSSS) will be used to assess psychosomatic symptoms. Higher scores indicate more severe psychosomatic symptoms. This outcome measures the change in PSSS total score from baseline to Week 2.
Baseline and Week 2
Change in Psychosomatic Symptoms Scale (PSSS) Total Score From Baseline to Week 6
時間枠：Baseline and Week 6
The Psychosomatic Symptoms Scale (PSSS) will be used to assess psychosomatic symptoms. Higher scores indicate more severe psychosomatic symptoms. This outcome measures the change in PSSS total score from baseline to Week 6.
Baseline and Week 6
Incidence of Adverse Events
時間枠：From Day 1 through Week 6
Adverse events will be recorded throughout the treatment and follow-up period. The number and proportion of participants experiencing adverse events will be summarized. The type, severity, duration, outcome, and relationship of adverse events to the intervention will be recorded.
From Day 1 through Week 6

その他の成果指標

結果測定
メジャーの説明
時間枠
Change in Brain Structural Imaging Metrics From 5.0T Magnetic Resonance Imaging
時間枠：Baseline and Day 6
Brain structural imaging metrics will be derived from 5.0T structural magnetic resonance imaging. This outcome explores changes in brain structural imaging metrics from baseline to post-treatment.
Baseline and Day 6
Change in Resting-state Functional Connectivity From 5.0T Functional Magnetic Resonance Imaging
時間枠：Baseline and Day 6
Resting-state functional connectivity will be derived from 5.0T resting-state functional magnetic resonance imaging. This outcome explores changes in resting-state functional connectivity from baseline to post-treatment.
Baseline and Day 6
Change in Diffusion Imaging Metrics From 5.0T Magnetic Resonance Imaging
時間枠：Baseline and Day 6
Diffusion imaging metrics will be derived from 5.0T diffusion magnetic resonance imaging. This outcome explores changes in diffusion imaging metrics from baseline to post-treatment.
Baseline and Day 6

協力者と研究者

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。

スポンサー

Yonggui Yuan

捜査官

  • 主任研究者：Yonggui Yuan, PhD、Zhongda hospital

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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5月30日

一次修了 (推定)

2027年5月30日

研究の完了 (推定)

2027年5月30日

試験登録日

最初に提出

2026年5月20日

QC基準を満たした最初の提出物

2026年5月27日

最初の投稿 (実際)

2026年5月28日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月28日

QC基準を満たした最後の更新が送信されました

2026年5月27日

最終確認日

2026年5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

  • MR-32-25-078202
  • 82271570 (その他の助成金/資金番号：National Natural Science Foundation of China)
  • BF2025611 (その他の助成金/資金番号：Jiangsu Province Frontier Technology Research and Development Program (Health Sector))

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?

いいえ

IPD プランの説明

Individual participant data will not be publicly shared because the study involves sensitive mental health information and neuroimaging data. Data sharing may increase the risk of participant identification. De-identified data may be made available from the principal investigator upon reasonable request and with approval from the ethics committee, when permitted by applicable regulations and the informed consent.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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