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Efficacy and Safety of Transcranial Temporal Interference Stimulation for Depression

2026년 5월 27일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

60

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Yue Zhou, MD Candidate
  • 전화번호: +86 15651003002
  • 이메일: 2725106172@qq.com

연구 연락처 백업

  • 이름: Yubo Zhang, MD Candidate
  • 전화번호: +86 18651617808
  • 이메일: 1301053461@qq.com

연구 장소

  • 중국
    • Jiangsu
      • Nanjing, Jiangsu, 중국, 210009
        • Zhongda Hospital Southeast University
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Yonggui Yuan, PhD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

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: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.
장치: 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.
다른 이름들:
  • Active tTIS Targeting Left ALIC
활성 비교기: 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.
장치: 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.
다른 이름들:
  • Active tTIS Targeting Left sgACC
가짜 비교기: 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.
장치: 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.
다른 이름들:
  • Sham tTIS

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in 24-item Hamilton Depression Rating Scale (HAMD-24) Total Score From Baseline to Week 1
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change in 24-item Hamilton Depression Rating Scale (HAMD-24) Total Score From Baseline to Week 2
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Change in Brain Structural Imaging Metrics From 5.0T Magnetic Resonance Imaging
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Yonggui Yuan

수사관

  • 수석 연구원: Yonggui Yuan, PhD, Zhongda hospital

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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)

2026년 5월 30일

기본 완료 (추정된)

2027년 5월 30일

연구 완료 (추정된)

2027년 5월 30일

연구 등록 날짜

최초 제출

2026년 5월 20일

QC 기준을 충족하는 최초 제출

2026년 5월 27일

처음 게시됨 (실제)

2026년 5월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 27일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • MR-32-25-078202
  • 82271570 (기타 보조금/기금 번호: National Natural Science Foundation of China)
  • BF2025611 (기타 보조금/기금 번호: Jiangsu Province Frontier Technology Research and Development Program (Health Sector))

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

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. .

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