Temporal Interference Transcranial Alternating Current Stimulation for Major Depressive Disorder
2026년 9월 6일 업데이트: Yumeng Ju, Central South University
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.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
102
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Yumeng Ju( Associate Researcher), PhD
- 전화번호: 86+18100731091
- 이메일: yumeng.ju@csu.edu.cn
연구 연락처 백업
- 이름: Lingsi Zeng, PhD Candidate
- 이메일: zenglsi@163.com
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
3
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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.
다른 이름들:
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실험적: 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.
다른 이름들:
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가짜 비교기: 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.
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Sham Temporal Interference transcranial Alternating Current Stimulation will mimic the sensory experience of active stimulation without delivering effective current.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline in the Hamilton Depression Rating Scale(HAMD-17) scores at week 2.
기간: 2 weeks(from baseline)
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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.
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2 weeks(from baseline)
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Generalized Anxiety Disorder-7 (GAD-7) Score
기간: Baseline to month 2 follow-up(post treatment)
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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.
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Baseline to month 2 follow-up(post treatment)
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Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score
기간: Baseline to month 2 follow-up
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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.
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Baseline to month 2 follow-up
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Adverse Events Related to treatment
기간: Baseline to month 2 follow-up
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Incidence, type, and severity of adverse events related to the transcranial temporal interference stimulation, assessed using a standardized Neuromodulation Adverse Effects Questionnaire.
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Baseline to month 2 follow-up
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Change in Patient Health Questionnaire-9 (PHQ-9)
기간: Baseline to month 2 follow-up
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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.
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Baseline to month 2 follow-up
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Change in the Hamilton Anxiety Rating Scale (HAMA) Score
기간: 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.
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Baseline to month 2 follow-up
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Change in Young Mania Rating Scale (YMRS) Score
기간: Baseline to month 2 follow-up
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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.
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Baseline to month 2 follow-up
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Change in Pittsburgh Sleep Quality Index (PSQI) Score
기간: Baseline to month 2 follow-up
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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.
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Baseline to month 2 follow-up
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Change in Beck Scale for Suicide Ideation (BSI) Score
기간: Baseline to month 2 follow-up
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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.
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Baseline to month 2 follow-up
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hange in 10-item Connor-Davidson Resilience Scale (CD-RISC-10) Score
기간: Baseline to month 2 follow-up
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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.
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Baseline to month 2 follow-up
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Change in Chinese Version of the Cognitive Emotion Regulation Questionnaire (CERQ-C) Score
기간: Baseline to month 2 follow-up
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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.
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Baseline to month 2 follow-up
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Change in State Anxiety Inventory (S-AI) Score
기간: Baseline to month 2 follow-up
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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.
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Baseline to month 2 follow-up
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Change in 17-item Hamilton Depression Rating Scale (HAMD-17) Score
기간: Baseline to month 2 follow-up
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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.
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Baseline to month 2 follow-up
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Change in Sheehan Disability Scale (SDS) Score
기간: Baseline to month 2 follow-up
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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.
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Baseline to month 2 follow-up
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Change in Snaith-Hamilton Pleasure Scale (SHAPS) Score
기간: Baseline to month 2 follow-up
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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).
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Baseline to month 2 follow-up
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Change in Ruminative Responses Scale (RRS) Score
기간: Baseline to month 2 follow-up
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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.
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Baseline to month 2 follow-up
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 연구 의자: Yan Zhang, PhD, Second Xiangya Hospital of Central South University
- 수석 연구원: Yumeng Ju, PhD, Second Xiangya Hospital of Central South University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 9월 15일
기본 완료 (추정된)
기본 완료
2027년 12월 1일
연구 완료 (추정된)
연구 완료
2028년 6월 1일
연구 등록 날짜
최초 제출
최초 제출
2026년 6월 9일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 7월 16일
처음 게시됨 (실제)
처음 게시됨
2026년 7월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 9월 10일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 6일
마지막으로 확인됨
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
기타 연구 ID 번호
- LYG20240121
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Individual participant data will not be shared because the dataset includes sensitive neuroimaging and biological data that may compromise participant confidentiality.
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아니
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아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .