Electrophysiological Biomarkers in Accelerated TMS for Depression
2026년 5월 22일 업데이트: Ali Tarık Altunç, Istanbul University - Cerrahpasa
Electrophysiological Biomarkers of Treatment Response in Major Depressive Disorder Patients Receiving Accelerated Transcranial Magnetic Stimulation
This study investigates whether physiological signals recorded during transcranial magnetic stimulation (TMS) can predict which patients with major depression respond to treatment.
Thirty-two adults with major depressive disorder receive an accelerated TMS protocol targeting the dorsomedial prefrontal cortex using a double-cone coil, delivered as four sessions per day over five to eight days.
Heart rate is continuously monitored throughout every stimulation session using a chest-strap sensor, and electroencephalography (EEG) is recorded before and after treatment.
Heart-brain coupling was assessed in a separate dedicated session after the target stimulation dose was reached.The primary clinical outcome is the change in depression severity measured by the Hamilton Depression Rating Scale (HAMD-17) from baseline to post-treatment.
Prespecified physiological outcomes include stimulation-evoked heart rate deceleration, resting-state EEG parameters, and heart-brain coupling metrics.
The aim is to evaluate whether these electrophysiological measures index target engagement and predict antidepressant response, potentially supporting their use as functional biomarkers for personalizing accelerated TMS in depression.
연구 개요
연구 유형
중재적
등록 (실제)
32
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Bakırköy
-
Istanbul, Bakırköy, 터키 (Türkiye)
- Istanbul University-Cerrahpaşa Cerrahpaşa Medical Faculty Psychiatry Department
-
-
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:
- Adults aged 18 to 65 years
- Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of major depressive disorder, of at least moderate severity, confirmed by structured psychiatric interview
- Insufficient response to at least one adequate trials of antidepressant pharmacotherapy during the current episode
- Stable psychotropic medication regimen for at least 4 weeks prior to enrollment
- Ability to provide written informed consent
Exclusion Criteria:
- Cardiac arrhythmia or use of antiarrhythmic medication
- Benzodiazepine use exceeding the equivalent of 1 mg/day lorazepam
- Active suicidal ideation
- Comorbid psychiatric disorders other than anxiety disorders (including bipolar disorder, psychotic disorders, substance use disorders, and primary obsessive-compulsive disorder)
- Standard contraindications to transcranial magnetic stimulation, including history of seizure, intracranial metal implants, cochlear implants, or implanted neurostimulators
- Pregnancy
- Severe or unstable medical illness
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: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Accelerated bilateral dmPFC-iTBS with double-cone coil
Participants received accelerated bilateral intermittent theta-burst stimulation (iTBS) targeting the dorsomedial prefrontal cortex (dmPFC) using a Cool DB-80 double-cone coil.
Treatment consisted of four sessions per day, delivering 1,200 pulses per session (600 pulses per hemisphere, applied sequentially to left and right dmPFC), at 120% of resting motor threshold.
The total course comprised 20 to 30 sessions over 5 to 8 days.
|
Stimulation was delivered using a MagPro R30 stimulator equipped with a Cool DB-80 double-cone coil (MagVenture A/S, Farum, Denmark).
The stimulation site was localized using the 25% nasion-inion scalp heuristic for dorsomedial prefrontal cortex (dmPFC) targeting.
The intermittent theta-burst stimulation (iTBS) protocol consisted of triplet 50 Hz bursts repeated at 5 Hz, applied as 2-second trains with 8-second inter-train intervals.
Each session delivered 600 pulses sequentially to the left and right dmPFC (1,200 pulses per session), at a target intensity of 120% of the hemisphere-specific resting motor threshold.
Four sessions were delivered per day with approximately 50-minute inter-session intervals.
The total treatment course was 20 sessions over 5 days, extended to 30 sessions over 8 days for partial responders.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Hamilton Depression Rating Scale (HAMD-17) Score
기간: Baseline, Day 5, and Day 8 for extended courses
|
Depression severity was assessed using the 17-item Hamilton Depression Rating Scale (HAMD-17) at baseline and within 1 week after completion of the accelerated iTBS course.
The HAMD-17 is a clinician-administered scale; scores range from 0 to 52, with higher scores indicating more severe depression.
Treatment response was defined as a 50% or greater reduction from baseline HAMD-17 score, and remission as a post-treatment HAMD-17 score of 7 or lower.
|
Baseline, Day 5, and Day 8 for extended courses
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Heart rate deceleration during stimulation
기간: Through completion of the treatment course, up to 8 days
|
Heart rate was continuously sampled at 1-second intervals using a Polar H10 chest strap during every stimulation session.
Heart rate deceleration (HRD) was calculated as the percentage reduction from the 1-minute pre-stimulation baseline heart rate to the mean stimulation heart rate, using the formula: HRD (%) = [(HR_baseline - HR_stimulation) / HR_baseline] x 100.
HRD was computed across four parameters (all left-sided sessions, all right-sided sessions, highest-intensity left-sided sessions, highest-intensity right-sided sessions) and averaged per participant.
Higher values indicate greater stimulation-induced heart rate deceleration.
|
Through completion of the treatment course, up to 8 days
|
|
Change in Beck Depression Inventory (BDI)
기간: Baseline, Day 5, and Day 8 for extended courses
|
Beck Depression Inventory (BDI), a self-report scale; total scores range from 0 to 63, with higher scores indicating more severe depression.
|
Baseline, Day 5, and Day 8 for extended courses
|
|
Change in Beck Anxiety Inventory (BAI)
기간: Baseline, Day 5, and Day 8 for extended courses
|
Beck Anxiety Inventory (BAI), a self-report scale; total scores range from 0 to 63, with higher scores indicating more severe anxiety.
|
Baseline, Day 5, and Day 8 for extended courses
|
|
Change in Beck Scale for Suicide Ideation (BSS)
기간: Baseline, Day 5, and Day 8 for extended courses
|
Beck Scale for Suicide Ideation (BSS), a self-report scale; total scores range from 0 to 38, with higher scores indicating greater suicidal ideation.
|
Baseline, Day 5, and Day 8 for extended courses
|
|
Change in Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR16) Total Score
기간: Baseline, Day 5, and Day 8 for extended courses
|
Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR16); total scores range from 0 to 27, with higher scores indicating more severe depression.
|
Baseline, Day 5, and Day 8 for extended courses
|
|
Change in Clinical Global Impression - Severity (CGI-S)
기간: Baseline, Day 5, and Day 8 for extended courses
|
Clinical Global Impression - Severity (CGI-S); scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients), with higher scores indicating greater illness severity.
|
Baseline, Day 5, and Day 8 for extended courses
|
|
Hamilton Depression Rating Scale (HAMD-17) Total Score at 30-Day Follow-up
기간: 30 days post-treatment
|
17-item Hamilton Depression Rating Scale (HAMD-17) assessed 30 days after completion of treatment; total scores range from 0 to 52, with higher scores indicating more severe depression.
|
30 days post-treatment
|
|
Resting State Quantitative EEG (qEEG) Spectral Power and Theta Cordance
기간: Baseline and completion of treatment (Day5 or Day8 for extended courses)
|
Absolute spectral power in the delta, theta, alpha, and beta frequency bands, derived from quantitative resting-state EEG (qEEG) analysis.
Power was computed across standard electrode regions.
Prefrontal theta cordance, a quantitative EEG measure combining absolute and relative theta-band power at prefrontal electrodes, derived from resting-state qEEG analysis.
|
Baseline and completion of treatment (Day5 or Day8 for extended courses)
|
|
Heart-Brain Coupling (HBC): Heart Rate Oscillation Power at the Stimulation Frequency
기간: Single dedicated measurement session after the target dose was reached, up to Day 8
|
Heart-brain coupling (HBC), a parameter quantifying the strength of stimulation-induced heart rate deceleration, computed as the mean oscillation power of cardiac rate at the frequency determined by the stimulation train interval (Dijkstra et al., 2023).
HBC ranges from 0 to 1. Measurements were obtained in a dedicated session using a 10 Hz protocol (50 pulses per train, 5-second train duration, 15 trains, 11-second inter-train interval), recorded with a Polar H10 chest strap and the HeartBrainConnect application.
HBC was assessed sequentially at four sites per participant: left dmPFC, left dorsolateral prefrontal cortex (DLPFC), right dmPFC and right DLPFC.
For each site, stimulation began at 28% below target intensity and increased by 2% per train, yielding 15 HBC values that were averaged to produce a per-site HBC value.
|
Single dedicated measurement session after the target dose was reached, up to Day 8
|
|
EEG Microstate Temporal Parameters
기간: Baseline and completion of treatment (Day5 or Day8 for extended courses)
|
Temporal parameters of the canonical resting-state EEG microstate classes (A, B, C, and D), including mean duration (milliseconds), occurrence (mean appearances per second), time coverage (percentage of recording time), and transition probabilities between classes.
Parameters were derived from microstate segmentation of resting-state EEG recordings.
|
Baseline and completion of treatment (Day5 or Day8 for extended courses)
|
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 (실제)
2024년 6월 13일
기본 완료 (실제)
2025년 3월 14일
연구 완료 (실제)
2025년 4월 14일
연구 등록 날짜
최초 제출
2026년 5월 18일
QC 기준을 충족하는 최초 제출
2026년 5월 22일
처음 게시됨 (실제)
2026년 5월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 29일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 22일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
De-identified individual-level data are not publicly available due to privacy and ethical restrictions on sensitive clinical data, but may be available from the corresponding author upon reasonable request and with appropriate ethics committee approval.
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. .