Efficacy and Mechanism of Transcranial Temporal Interference Stimulation (tTIS) for Patients With Obsessive-Compulsive Disorders
2026년 9월 1일 업데이트: Xiang Yang Zhang, Beijing HuiLongGuan Hospital
Individualized Targeted Transcranial Temporal Interference Stimulation for for Patients With Obsessive-Compulsive Disorders: A Double-Blinded, Randomized Controlled Trial
Targeted temporal interference stimulation (tTIS) of the nucleus accumbens (NAc) may modulate the abnormal electrophysiological activity in individuals with obsessive-compulsive disorder (OCD), thereby improving their obsessive-compulsive symptoms.
연구 개요
상세 설명
This study will investigate the therapeutic effects and potential neural mechanisms of targeted temporal interference stimulation (tTIS) of the nucleus accumbens in individuals with obsessive-compulsive disorder (OCD).
Participants will receive either active or sham tTIS for 5 consecutive days.
Clinical symptoms will be assessed using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and additional psychological questionnaires at baseline, immediately after the intervention, and during follow-up assessments.
Behavioral tasks, including instrumental learning and probabilistic reversal learning paradigms, will be administered to assess intervention-related changes in behavioral performance.
Resting-state electroencephalography (EEG) and multimodal magnetic resonance imaging (MRI) will be acquired before and after the intervention to evaluate intervention-related changes in brain function and structure.
The study aims to evaluate the clinical efficacy of nucleus accumbens-targeted tTIS and to explore its potential behavioral and neurobiological mechanisms in OCD.
연구 유형
중재적
등록 (추정된)
80
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Xiang-yang Zhang
- 전화번호: 18513299860
- 이메일: zhangxy99@mail.tsinghua.edu.cn
연구 장소
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Anhui
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Hefei, Anhui, 중국, 230000
- 모병
- The Fourth People's Hospital of Anhui Province
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연락하다:
- Zhang Xiang-yang
- 전화번호: 18513299860
- 이메일: zhangxy99@mail.tsinghua.edu.cn
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연락하다:
- 이메일: 18981248677@163.com
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수석 연구원:
- Xinyue Zhang
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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:
- Were between 18 and 65 years old;
- Were diagnosed with OCD by an experienced psychiatrist utilizing the Structured Clinical Interview for DSM-5 (SCID);
- Were able to participate in the entire trial and face-to-face on-site assessment
Exclusion Criteria:
- Pregnant or breastfeeding;
- Suffered from organic brain diseases or severe physical illness;
- Had a history of substance or alcohol abuse;
- Presence of comorbid psychiatric disorders (e.g., major depressive disorder) or a high risk of suicide;
- Have received electroconvulsive therapy, transcranial magnetic stimulation, tDCS, tACS, or other neurostimulation treatments within the past 6 months;
- Presence of contraindications to MRI or tTIS, such as severe head trauma, prior brain surgery, intracranial or cardiac metallic implants, etc.
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
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Nucleus accumbens group (tTIS)
Participants assigned to the active tTIS group will receive temporal interference stimulation targeting the right nucleus accumbens (NAc).
Individualized electrode configurations will be determined based on each participant's structural MRI.
Two high-frequency alternating currents at 2000 Hz and 2130 Hz will be applied, with a peak current intensity of up to 2 mA for each stimulation channel.
Each stimulation session will last 30 minutes and will include a 30-second linear ramp-up at the beginning and a 30-second linear ramp-down at the end.
Electrode impedance will be maintained below 8 kΩ.
Stimulation will be administered twice daily for 5 consecutive days, with an interval of approximately 90-120 minutes between the two daily sessions.
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Transcranial temporal interference stimulation (tTIS) is a novel neurostimulation technique that utilizes two or more electric fields of specific frequencies to modulate the oscillations of neurons at the desired spatial location in the brain.
The physics of tTIS offers the advantage of noninvasively regulating deep brain structures and minimally stimulating the overlying cortex outside the selected target.
다른 이름들:
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가짜 비교기: Control Group
Participants assigned to the sham control group will undergo the same procedures and stimulation settings as those in the active tTIS group, including electrode placement, stimulation frequencies, nominal current intensity, ramp-up and ramp-down phases, session duration, and treatment schedule.
However, no therapeutic stimulation current will be delivered.
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Transcranial temporal interference stimulation (tTIS) is a novel neurostimulation technique that utilizes two or more electric fields of specific frequencies to modulate the oscillations of neurons at the desired spatial location in the brain.
The physics of tTIS offers the advantage of noninvasively regulating deep brain structures and minimally stimulating the overlying cortex outside the selected target.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Obsessive-compulsive symptoms
기간: Baseline, immediately after completion of the 5-day intervention (Day 5), and at 1-week, 1-month, and 3-month follow-up
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Obsessive-compulsive symptom severity will be assessed using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).
The Y-BOCS total score ranges from 0 to 40, with higher scores indicating greater symptom severity.
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Baseline, immediately after completion of the 5-day intervention (Day 5), and at 1-week, 1-month, and 3-month follow-up
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Self-reported obsessive-compulsive symptoms
기간: Baseline, immediately after completion of the 5-day intervention (Day 5), and at 1-week, 1-month, and 3-month follow-up
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The reduction rate of the score of Obsessive-Compulsive Inventory-Revised (OCI-R), a self-rating scale of OCD symptoms severity, was employed as a secondary outcome.
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Baseline, immediately after completion of the 5-day intervention (Day 5), and at 1-week, 1-month, and 3-month follow-up
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Multimodal MRI measures
기간: Baseline, after completion of 5-day intervention
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Multimodal MRI data will be acquired at baseline and after completion of the 5-day intervention using a 3.0-T MRI scanner.
The imaging protocol includes T1-weighted and T2-weighted structural MRI, resting-state blood-oxygen-level-dependent (BOLD) functional MRI, and diffusion-weighted imaging (DWI).
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Baseline, after completion of 5-day intervention
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Resting-state electroencephalography (EEG) measures
기간: Baseline, after completion of 5-day intervention
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Resting-state EEG will be recorded at baseline and after completion of the 5-day intervention.
Changes in EEG-derived neurophysiological measures between baseline and post-intervention will be assessed to characterize intervention-related alterations in brain activity.
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Baseline, after completion of 5-day intervention
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Behavioral task performance
기간: Baseline, after completion of the 5-day intervention
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Behavioral task performance will be assessed at baseline and after the 5-day intervention using computerized cognitive tasks.
Task-derived behavioral measures, such as instrumental learning tasks and probabilistic reversal learning tasks, will be analyzed to evaluate intervention-related changes in behavioral performance.
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Baseline, after completion of the 5-day intervention
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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 10월 16일
기본 완료 (추정된)
2027년 12월 31일
연구 완료 (추정된)
2027년 12월 31일
연구 등록 날짜
최초 제출
2026년 9월 1일
QC 기준을 충족하는 최초 제출
2026년 9월 1일
처음 게시됨 (실제)
2026년 9월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 1일
마지막으로 확인됨
2026년 9월 1일
추가 정보
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개별 참가자 데이터(IPD) 계획
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IPD 계획 설명
Deidentified individual participant data underlying the results reported in publications may be shared with qualified researchers upon reasonable request and approval by the principal investigator and relevant institutional authorities.
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