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Individualized Temporally Interfering Electrical Stimulation in Major Depressive Disorder

2026年11月6日 更新者：Xianyun Kang、Tianjin Medical University General Hospital

Closed-Loop Bio-Machine Interaction System and Applications in Psychiatric Diagnosis and Treatment

Temporally interfering (TI) electrical stimulation is a novel noninvasive neuromodulation technique with high spatial resolution. Although its effects on human brain function and behavior have been increasingly investigated, its clinical utility in major depressive disorder (MDD) has not been established. This trial aims to evaluate the efficacy and safety of TI electrical stimulation in MDD patients.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

This is a multicenter, double-blind, randomized, sham-controlled trial including three parallel arms: (1)single-target active stimulation targeting the right primary auditory cortex (A1); (2) dual-target active stimulation targeting the right A1 and the right dorsolateral prefrontal cortex (DLPFC); (3)sham stimulation. All interventions will be delivered over two consecutive weeks, comprising ten treatment visits, with 20 minutes of stimulation applied to each target.

研究の種類

介入

入学 (推定)

75

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

研究場所

  • 中国
    • Fujian
      • Fuzhou、Fujian、中国、350007
        • 募集
        • Fuzhou Neuropsychiatric Hospital Affiliated to Fujian Medical University
        • コンタクト：
    • Tianjin Municipality
      • Tianjin、Tianjin Municipality、中国、300222
        • 募集
        • Tianjin Anding Hospital
        • コンタクト：

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

18年～65年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for MDD, confirmed independently by two psychiatrists;
  2. Currently experiencing a depressive episode;
  3. Hamilton Depression Rating Scale 17-item (HAMD-17) score ≥ 17;
  4. Aged between 18-65 years;
  5. No restrictions on sex or gender;
  6. Attained at least junior high school education; lower education permitted if cognitive capacity is confirmed by a physician;
  7. Normal or corrected-to-normal vision and normal hearing;
  8. No use of antidepressant within two weeks prior to enrollment, or ongoing antidepressant treatment judged by a psychiatrist to be in a stable treatment phase;
  9. Ability to read and understand informed consent and self-report assessment scales;
  10. Willingness to participate in the study, with written informed consent provided by the participant or a legal guardian.

Exclusion Criteria:

  1. History of any psychiatric disorder other than MDD;
  2. History of traumatic brain injury or coma;
  3. History of organic brain disease or severe systemic medical illness;
  4. History of cochlear implants, pacemakers, or other implanted brain devices;
  5. History of epileptic seizures or family history of epilepsy;
  6. Obvious suicidal or impulsive violent behavior;
  7. Receipt of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or other neuromodulation therapies within the past six months;
  8. History of alcohol use disorder or use of other psychoactive substances;
  9. Participation in other interventional clinical trials;
  10. Any condition precluding informed consent or compliance with study procedures.

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：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：single-target active TI electrical stimulation group
デバイス：Single-target active temporally interfering electrical stimulation

Single-target active stimulation targeting the right primary auditory cortex (A1), each target stimulation phase will last 20 minutes, including a 30-second ramp-up at onset and a 30-second ramp-down at termination. Alternating currents with frequencies of f1 = 2000 Hz and f2 = 2040 Hz will be delivered through the two electrode pairs, and the total current intensity across the two electrode pairs will be fixed at 4 mA (AC, peak-to-base). The intervention will be administered over two consecutive weeks, with participants receiving stimulation on five days per week.
実験的：dual-target active TI electrical stimulation group
デバイス：Dual-target active temporally interfering electrical stimulation

Dual-target active stimulation targeting the right A1 and the right dorsolateral prefrontal cortex (DLPFC), each target stimulation phase will last 20 minutes, including a 30-second ramp-up at onset and a 30-second ramp-down at termination. For each target, two pairs of electrodes will be used; the alternating current frequency and total stimulation intensity will be the same as those in the single-target active TI electrical stimulation group.The intervention will be administered over two consecutive weeks, with participants receiving stimulation on five days per week.
偽コンパレータ：sham TI electrical stimulation group
デバイス：Sham temporally interfering electrical stimulation

Sham TI electrical stimulation group will follow the same session duration, treatment frequency, and procedural setup as the active stimulation groups. However, electrical stimulation will be limited to an initial 30-second ramp-up followed immediately by a 30-second ramp-down, after which no current will be delivered for the remainder of the session.

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
Hamilton Depression Rating Scale 17-item (HAMD-17)
時間枠：Baseline, Week 1, Week 2, Week 4.

Total scores range from 0 to 52, with higher scores indicating greater depressive symptom severity (worse outcomes).
Baseline, Week 1, Week 2, Week 4.

二次結果の測定

結果測定
メジャーの説明
時間枠
Patient Health Questionnaire-9 (PHQ-9)
時間枠：Baseline, Week 1, Week 2, Week 4.

Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity (worse outcomes).
Baseline, Week 1, Week 2, Week 4.
Hamilton Anxiety Rating Scale (HAMA)
時間枠：Baseline, Week 1, Week 2, Week 4.

Total scores range from 0 to 56, with higher scores indicating greater anxiety symptom severity (worse outcomes).
Baseline, Week 1, Week 2, Week 4.
Generalized Anxiety Disorder 7-item (GAD-7)
時間枠：Baseline, Week 1, Week 2, Week 4.

Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity (worse outcomes).
Baseline, Week 1, Week 2, Week 4.
Young Mania Rating Scale (YMRS)
時間枠：Baseline, Week 1, Week 2, Week 4.

Total scores range from 0 to 60, with higher scores indicating greater manic symptom severity (worse outcomes).
Baseline, Week 1, Week 2, Week 4.
Electroencephalographic (EEG) Power in the Gamma Frequency Band
時間枠：Baseline, Week 1, Week 2, Week 4.

Gamma-band EEG power will be assessed using spectral analysis of EEG recordings.
Baseline, Week 1, Week 2, Week 4.
40-Hz Auditory Steady-State Response (ASSR) Event-Related Spectral Perturbation (ERSP)
時間枠：Baseline, Week 1, Week 2, Week 4.

The 40-Hz ASSR will be assessed using electroencephalography (EEG). Event-related spectral perturbation (ERSP) quantifies stimulus-induced changes in oscillatory power relative to a prestimulus baseline. ERSP will be expressed in decibels (dB), with higher values indicating greater stimulus-related power enhancement.
Baseline, Week 1, Week 2, Week 4.
40-Hz Auditory Steady-State Response (ASSR) Inter-Trial Coherence (ITC)
時間枠：Baseline, Week 1, Week 2, Week 4.

The 40-Hz ASSR will be assessed using electroencephalography (EEG). Inter-trial coherence (ITC) quantifies the consistency of oscillatory phase across repeated auditory stimulus presentations. ITC values range from 0 to 1, with higher values indicating greater phase consistency.
Baseline, Week 1, Week 2, Week 4.
Magnetic Resonance Imaging (MRI)
時間枠：Baseline, Week 2.

Changes in brain structure and functional organization, assessed using MRI, will be included as secondary neuroimaging outcomes.
Baseline, Week 2.

その他の成果指標

結果測定
メジャーの説明
時間枠
Athens Insomnia Scale (AIS)
時間枠：Baseline, Week 1, Week 2, Week 4.

Total scores range from 0 to 24, with higher scores indicating greater insomnia symptom severity (worse outcomes).
Baseline, Week 1, Week 2, Week 4.
Attention Control Scale (ACS)
時間枠：Baseline, Week 1, Week 2, Week 4.

The ACS consists of 20 items assessing two dimensions of attentional control: Attentional Focusing and Attentional Shifting. Total scores range from 20 to 80, with higher scores indicating better overall attentional control abilities (better outcomes). Attentional Focusing reflects the ability to maintain attention and resist distractions, whereas Attentional Shifting reflects the ability to flexibly shift attention between tasks or stimuli.
Baseline, Week 1, Week 2, Week 4.
Chinese 10-item Rumination Response Scale (RRS-10)
時間枠：Baseline, Week 1, Week 2, Week 4.

The RRS-10 consists of 10 items assessing two dimensions of rumination: Brooding and Reflection, each comprising five items. Total scores range from 10 to 40, with higher scores indicating greater overall rumination (generally worse outcomes). Brooding reflects maladaptive rumination, whereas Reflection reflects purposeful self-focused thinking and does not necessarily indicate worse outcomes.
Baseline, Week 1, Week 2, Week 4.
Emotion Regulation Questionnaire (ERQ) - Cognitive Reappraisal Subscale
時間枠：Baseline, Week 1, Week 2, Week 4.

The Cognitive Reappraisal subscale of the ERQ consists of 6 items assessing the tendency to regulate emotions by reinterpreting emotional situations. Total scores range from 6 to 42, with higher scores indicating greater use of cognitive reappraisal, generally considered a more adaptive emotion regulation strategy (better outcomes).
Baseline, Week 1, Week 2, Week 4.
Emotion Regulation Questionnaire (ERQ) - Expressive Suppression Subscale
時間枠：Baseline, Week 1, Week 2, Week 4.

The Expressive Suppression subscale of the ERQ consists of 4 items assessing the tendency to inhibit outward emotional expression. Total scores range from 4 to 28, with higher scores indicating greater use of expressive suppression, generally considered a less adaptive emotion regulation strategy (worse outcomes).
Baseline, Week 1, Week 2, Week 4.
Cognitive Flexibility Inventory (CFI)
時間枠：Baseline, Week 1, Week 2, Week 4.

The CFI consists of 20 items assessing two dimensions of cognitive flexibility: Alternatives (13 items) and Control (7 items). Total scores range from 20 to 100, with higher scores indicating greater cognitive flexibility (better outcomes). Alternatives reflects the ability to generate multiple explanations and solutions to difficult situations, whereas Control reflects the tendency to perceive difficult situations as controllable.
Baseline, Week 1, Week 2, Week 4.

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

Tianjin Medical University General Hospital

協力者

Tianjin Anding Hospital
Fuzhou Neuropsychiatric Hospital Affiliated to Fujian Medical University

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 (実際)

2025年3月11日

一次修了 (推定)

2027年6月15日

研究の完了 (推定)

2027年6月15日

試験登録日

最初に提出

2026年11月3日

QC基準を満たした最初の提出物

2026年11月6日

最初の投稿 (実際)

2026年11月9日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月9日

QC基準を満たした最後の更新が送信されました

2026年11月6日

最終確認日

2026年11月1日

詳しくは

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追加の関連 MeSH 用語

その他の研究ID番号

  • XY1895

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いいえ

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