- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07930000
Phase-Locked Accelerated Intermittent Theta Burst Stimulation for Treatment-Resistant Depression
Development of Precision Medicine in the Field of iTBS on Patients With TRD Using Multimodal Functional Brain Imaging and Deep Learning
This study aims to investigate whether synchronizing accelerated intermittent theta burst stimulation (aiTBS) with an individual's ongoing brain activity improves treatment outcomes in adults with Treatment-Resistant Depression (TRD).
Participants were randomly assigned to one of two treatment groups:
- Phase-locked aiTBS (PL-aiTBS): Magnetic stimulation was synchronized with a specific phase of ongoing brain activity measured using electroencephalography (EEG).
- Random-phase aiTBS (RP-aiTBS): Participants received the same stimulation protocol without synchronization to a specific phase of brain activity.
Both groups received personalized stimulation based on their individual theta frequency. Treatment consisted of 10 sessions over three consecutive days, with three sessions on Day 1, three sessions on Day 2, and four sessions on Day 3 (3-3-4 schedule). Each session delivered 1,800 magnetic pulses, resulting in a total of 18,000 pulses per participant.
The primary objective was to compare changes in depressive symptoms between the two treatment groups. Depression severity was assessed using the 17-item Hamilton Depression Rating Scale (HAM-D) and the Montgomery-Åsberg Depression Rating Scale (MADRS) at baseline (before the first stimulation session), mid-treatment (after the sixth session, Day 2), post-treatment (after the tenth session, Day 3), and follow-up (Day7).
Resting-state EEG recordings were collected before and after stimulation sessions to investigate treatment-related changes in neural oscillatory activity, phase-amplitude coupling, functional connectivity, and other neurophysiological measures, as well as their potential associations with improvements in depressive symptoms.
연구 개요
상태
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Taipei City
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Taipei, Taipei City, 대만, 112
- Cheng Hsin General Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adults aged 18 to 70 years.
- Diagnosis of major depressive disorder (MDD).
- Inadequate response to at least two antidepressant trials of adequate dose and duration.
- A 17-item Hamilton Depression Rating Scale (HAM-D) score of 9 or higher.
- A Montgomery-Åsberg Depression Rating Scale (MADRS) score of 16 or higher.
- Willingness to participate in the study and provision of written informed consent.
Exclusion Criteria:
- Other psychiatric disorders or serious medical conditions.
- Psychotic disorders.
- Current illicit drug use or alcohol use disorder.
- Neurological or seizure disorders.
- Contraindications to transcranial magnetic stimulation (TMS), including cardiac pacemakers or metallic implants.
- Pregnancy or postpartum depression.
- Electroconvulsive therapy (ECT) within the previous 12 months.
- Unstable medical illness.
- Inability to comply with study procedures.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Phase-Locked Accelerated iTBS (PL-aiTBS)
Participants received individualized accelerated intermittent theta burst stimulation (aiTBS) synchronized to a specific phase of ongoing frontal theta oscillations measured using EEG. |
Stimulation was delivered to the left dorsolateral prefrontal cortex (DLPFC; F3) using an individualized theta-frequency-based iTBS protocol. Each participant received 10 sessions over three consecutive days (3-3-4 schedule), with 1,800 pulses per session (18,000 pulses total). Stimulation was synchronized to the trough of ongoing frontal theta oscillations using real-time EEG phase estimation. |
|
활성 비교기: Random-Phase Accelerated iTBS (RP-aiTBS)
Participants received the same individualized aiTBS protocol without phase-locked synchronization to ongoing frontal theta oscillations. |
Participants received the same individualized iTBS protocol targeting the left DLPFC (F3), consisting of 10 sessions over three consecutive days (3-3-4 schedule), with 1,800 pulses per session (18,000 pulses total). Stimulation was delivered without phase-locked synchronization to ongoing frontal theta oscillations. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in HAM-D Total Score
기간: Baseline (Day 1), Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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Depression severity was assessed using the 17-item Hamilton Depression Rating Scale (HAM-D), with total scores ranging from 0 to 52. Higher scores indicate greater depressive symptom severity. Changes in total scores from baseline were evaluated at each post-baseline assessment. |
Baseline (Day 1), Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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Change in MADRS Total Score
기간: Baseline (Day 1), Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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Depression severity was assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), with total scores ranging from 0 to 60. Higher scores indicate greater depressive symptom severity. Changes in total scores from baseline were evaluated at each post-baseline assessment. |
Baseline (Day 1), Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Response Rate Based on HAM-D
기간: Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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Treatment response was defined as a reduction of at least 50% in HAM-D total score relative to baseline. The response rate was calculated as the percentage of participants meeting this criterion at each assessment time point. |
Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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Response Rate Based on MADRS
기간: Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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Treatment response was defined as a reduction of at least 50% in MADRS total score relative to baseline. The response rate was calculated as the percentage of participants meeting this criterion at each assessment time point. |
Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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Remission Rate Based on HAM-D17
기간: Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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Remission was defined as a HAM-D17 total score of 7 or lower. The remission rate was calculated as the percentage of participants meeting this criterion at each assessment time point. |
Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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Remission Rate Based on MADRS
기간: Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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Remission was defined as a MADRS total score of 10 or lower. The remission rate was calculated as the percentage of participants meeting this criterion at each assessment time point. |
Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline in Resting-State EEG Spectral Power
기간: Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
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Resting-state electroencephalography (EEG) was recorded to assess changes in neural oscillatory activity following accelerated intermittent theta burst stimulation (aiTBS). Spectral power was quantified across conventional frequency bands, including delta, theta, alpha, beta, and gamma. Changes in spectral power from baseline were evaluated across treatment stages. |
Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
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Change From Baseline in Resting-State EEG Phase-Amplitude Coupling
기간: Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
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Resting-state EEG was analyzed to assess phase-amplitude coupling (PAC), reflecting the relationship between the phase of lower-frequency oscillations and the amplitude of higher-frequency activity. Changes in PAC strength from baseline were evaluated across treatment stages to characterize neurophysiological effects of aiTBS. |
Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
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Resting-State EEG Functional Connectivity
기간: Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
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Resting-state EEG functional connectivity was assessed using phase-based synchronization measures between brain regions. Changes in functional connectivity from baseline were evaluated across treatment stages to investigate stimulation-related alterations in neural synchronization. |
Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
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Change From Baseline in Resting-State EEG Microstate Parameters
기간: Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
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Resting-state EEG microstate analysis was used to characterize changes in the temporal dynamics of large-scale brain network activity. Microstate parameters included mean duration (ms), occurrence rate (events/s), time coverage (%), and transition probabilities between microstate classes. Changes in these parameters were evaluated across treatment sessions to investigate stimulation-related alterations in brain network dynamics. |
Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- (985)111A-63
- (1126)113A-56 (기타 식별자: Cheng Hsin General Hospital Institutional Review Board)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Individual participant data will not be shared publicly due to participant confidentiality and privacy considerations. No external IPD sharing is currently planned.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .