Context-Guided Personalized iTBS for Depression
2026년 8월 3일 업데이트: Zhi Yang, Capital Medical University
Research on Intelligent Optimization of Neuromodulation for Depression Based on Contextual Neuroimaging
The goal of this randomized clinical trial is to learn whether context-guided personalized intermittent theta burst stimulation (iTBS) works better than standard iTBS for adults with major depressive disorder. iTBS is a noninvasive treatment that uses magnetic pulses to stimulate specific areas of the brain.
Participants will be assigned by chance to one of two treatment groups. The standard treatment group will receive iTBS at a commonly used target in the left dorsolateral prefrontal cortex after watching a neutral video. The personalized treatment group will receive iTBS at an individual brain target selected using magnetic resonance imaging data. Before each treatment session, participants in this group will watch a positive emotional video intended to activate brain functions related to the selected target.
Both groups will receive five iTBS sessions per day for five consecutive treatment days. Participants will continue their stable antidepressant treatment during the study.
The main question is whether context-guided personalized iTBS results in a higher treatment response rate than standard iTBS two weeks after treatment. Treatment response is defined as a reduction of at least 50% from baseline in the 17-item Hamilton Depression Rating Scale score.
Researchers will also compare early changes in depression, anxiety and other clinical symptoms, changes in brain imaging measures, and any side effects. Clinical and brain imaging assessments will be conducted before and after the treatment course, and clinical symptoms will be assessed again two weeks after treatment.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (추정된)
등록
60
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: Zhi Yang, PhD
- 전화번호: +86 186 1171 0840
- 이메일: yangz@mail.ccmu.edu.cn
연구 장소
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Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100088
- Beijing Anding Hospital, Capital Medical University
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연락하다:
- Zhi Yang, PhD
- 전화번호: +8618611710840
- 이메일: yangz@mail.ccmu.edu.cn
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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
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Male or female outpatients or inpatients aged 18 to 55 years, inclusive.
- Right-handed.
- Diagnosis of major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed using the Mini International Neuropsychiatric Interview (MINI). Both first and recurrent depressive episodes are eligible.
- A 17-item Hamilton Depression Rating Scale (HAMD-17) total score of at least 14 at both screening and baseline.
- At enrollment, participants may be antidepressant-free or may have received an antidepressant at no less than the minimum effective dose for at least 4 weeks. The antidepressant may be combined with no more than two other medications, and the type and dosage of medications must remain unchanged from enrollment until study completion.
- At least primary school education and able to understand the study procedures and requirements.
- Able to undergo magnetic resonance imaging and intermittent theta burst stimulation safely.
- Voluntarily agrees to participate and provides written informed consent.
Exclusion Criteria:
- Serious or unstable medical or neurological illness.
- Pregnancy or breastfeeding.
- History of seizure, epilepsy, hydrocephalus, or central nervous system tumor.
- Contraindication to magnetic resonance imaging, including claustrophobia, an electronic or metallic implant, or a non-removable metallic dental prosthesis.
- Receipt of systematic modified electroconvulsive therapy, transcranial magnetic stimulation, deep brain stimulation, vagus nerve stimulation, or another physical neuromodulation treatment within 3 months before screening.
- Excessive head motion during MRI scanning (rotation exceeding 3.0° and/or translation exceeding 3 mm)
- Resting motor threshold remaining at or above 70% of the device maximum stimulator output after repeated testing, when the investigator considers continued treatment to present a safety concern.
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
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Context-Guided Personalized iTBS
Participants assigned to this arm will receive context-guided personalized intermittent theta burst stimulation (iTBS).
An individualized stimulation target in the left or right dorsolateral prefrontal cortex will be selected based on the participant's functional magnetic resonance imaging data.
Before each iTBS session, participants will watch a positive emotional video intended to engage the brain functions related to the individualized target.
Participants will receive five iTBS sessions per day, with approximately 50 minutes between sessions, for five consecutive treatment days.
Each session will last approximately 10 minutes and deliver 1,800 pulses at 100% of the resting motor threshold.
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An individualized stimulation target in the left or right dorsolateral prefrontal cortex is selected using the participant's functional magnetic resonance imaging data.
Before each stimulation session, the participant watches a positive emotional video intended to engage brain functions related to the selected target.
Intermittent theta burst stimulation is delivered at 100% of the resting motor threshold.
Each session delivers 1,800 pulses over approximately 10 minutes.
Participants receive five sessions per day, with approximately 50 minutes between sessions, for five consecutive treatment days.
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활성 비교기: Standard Left DLPFC iTBS
Participants assigned to this arm will receive standard intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex.
Before each iTBS session, participants will watch a neutral video.
Participants will receive five iTBS sessions per day, with approximately 50 minutes between sessions, for five consecutive treatment days.
Each session will last approximately 10 minutes and deliver 1,800 pulses at 100% of the resting motor threshold.
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Intermittent theta burst stimulation is delivered to a standard treatment target in the left dorsolateral prefrontal cortex.
Before each stimulation session, the participant watches a neutral video.
Stimulation is delivered at 100% of the resting motor threshold.
Each session delivers 1,800 pulses over approximately 10 minutes.
Participants receive five sessions per day, with approximately 50 minutes between sessions, for five consecutive treatment days.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Treatment Response Rate at 2-Week Follow-up Based on HAMD-17
기간: At 2 weeks after completion of treatment (Day 21 ± 2 days).
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The treatment response rate is defined as the proportion of participants with a reduction of at least 50% from baseline in the total score of the 17-item Hamilton Depression Rating Scale (HAMD-17) at the 2-week follow-up.
The HAMD-17 is a clinician-rated scale used to assess the severity of depressive symptoms, with lower scores indicating fewer depressive symptoms.
Treatment response rates will be compared between the context-guided personalized iTBS arm and the standard left DLPFC iTBS arm.
The HAMD-17 total score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity.
Change from baseline is calculated as the post-baseline score minus the baseline score, with negative values indicating improvement.
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At 2 weeks after completion of treatment (Day 21 ± 2 days).
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Adverse Events
기간: From the first treatment session through the 2-week follow-up after completion of treatment
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The number and proportion of participants experiencing one or more adverse events will be recorded for each treatment arm.
Adverse events may include headache, scalp discomfort, muscle twitching, transient mood changes, or other adverse events occurring during the treatment and follow-up periods.
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From the first treatment session through the 2-week follow-up after completion of treatment
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Early Treatment Response Rate Based on HAMD-17
기간: Baseline to immediately after completion of the treatment intervention
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Early treatment response is defined as a reduction of at least 20% from baseline in the total score of the 17-item Hamilton Depression Rating Scale (HAMD-17) immediately after completion of the treatment intervention.
The outcome will be summarized as the proportion of participants meeting this response criterion in each treatment arm.
Lower HAMD-17 scores indicate fewer depressive symptoms.
The HAMD-17 total score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity.
Change from baseline is calculated as the post-baseline score minus the baseline score, with negative values indicating improvement.
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Baseline to immediately after completion of the treatment intervention
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Change From Baseline in HAMD-17 Factor Scores
기간: Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
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Changes from baseline in the prespecified factor scores of the 17-item Hamilton Depression Rating Scale (HAMD-17) will be assessed at the 2-week follow-up.
For each factor, the change score will be calculated as the follow-up score minus the baseline score.
A greater reduction indicates greater improvement in the corresponding depressive symptom domain.
The HAMD-17 consists of 17 items; 9 items are scored from 0 to 4 and 8 items are scored from 0 to 2. The total score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity.
Change is calculated as the post-baseline score minus the baseline score; negative values indicate improvement.
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Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
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Change From Baseline in QIDS-SR16 Total Score
기간: Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
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Changes from baseline in the total score of the 16-item Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16) will be assessed immediately after completion of the treatment intervention and at the 2-week follow-up.
Lower scores indicate fewer self-reported depressive symptoms.
The QIDS-SR16 total score ranges from 0 to 27, with higher scores indicating greater depressive symptom severity.
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Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
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Change From Baseline in HAMA Total Score
기간: Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
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Changes from baseline in the total score of the Hamilton Anxiety Rating Scale (HAMA) will be assessed immediately after completion of the treatment intervention and at the 2-week follow-up.
The HAMA is a clinician-rated measure of anxiety symptom severity, with lower scores indicating fewer anxiety symptoms.
The 14-item HAMA total score ranges from 0 to 56, with higher scores indicating greater anxiety symptom severity.
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Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 수석 연구원: Zhi Yang, PhD, Beijing Anding Hospital, Capital Medical 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 1일
기본 완료 (추정된)
기본 완료
2027년 10월 30일
연구 완료 (추정된)
연구 완료
2027년 10월 30일
연구 등록 날짜
최초 제출
최초 제출
2026년 7월 29일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 7월 29일
처음 게시됨 (실제)
처음 게시됨
2026년 8월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 8월 5일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 3일
마지막으로 확인됨
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- BRWEP2024W072120106
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 current informed consent and ethics-approved protocol authorize the coded and de-identified clinical and neuroimaging data for use within this study only.
Study data will be stored and analyzed on a secure internal institutional server.
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. .