Accelerated iTBS for PTSD and Depression
2026년 9월 15일 업데이트: Lawson Research Institute of St. Joseph's
Accelerated Intermittent Theta Burst Stimulation for Depression in Post-Traumatic Stress Disorder: A Single-Arm, Open-Label Feasibility Study
The goal of this pilot clinical trial is to learn if a faster brain stimulation schedule is practical, safe, tolerable, and acceptable. This study looks at accelerated intermittent theta burst stimulation, or accelerated iTBS. This is a non-invasive type of magnetic brain stimulation. This study is for adults with post-traumatic stress disorder (PTSD) and major depressive disorder (MDD).
The main questions this study aims to answer are:
- Can participants complete six short brain stimulation sessions per day for five days?
- Is this treatment schedule safe and tolerable for participants?
- What changes occur in depression symptoms, PTSD symptoms, anxiety, quality of life, and brain activity over time?
Participants will:
- Complete health screening and baseline assessments.
- Receive six short sessions of magnetic brain stimulation per day for five days.
- Have their brain activity measured using an EEG recording.
- Return for a post-treatment assessment at Week 2 and follow-up visits at Week 5 and Week 12.
연구 개요
상태
모병
상세 설명
This is a single-arm, open-label pilot feasibility study of accelerated intermittent theta burst stimulation, also called accelerated iTBS, in adults with both post-traumatic stress disorder (PTSD) and major depressive disorder (MDD).
The study is designed to assess whether an accelerated iTBS schedule can be delivered safely, tolerably, and feasibly in a clinical setting.
The main focus is feasibility, including recruitment, treatment adherence, participant retention, safety, tolerability, and participant acceptability.
About 12 to 16 participants will receive active accelerated iTBS.
Treatment will include six short stimulation sessions per day over five consecutive days, for a total of 30 sessions.
The study will also collect exploratory information over time on depression symptoms, PTSD symptoms, anxiety, daily functioning, quality of life, and brain activity measured by EEG.
Because this is a small pilot study, the analysis will be mainly descriptive.
The results will help refine study procedures and guide the design of a larger future clinical trial.
연구 유형
중재적
등록 (추정된)
16
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Radhika Kelkar, MD
- 전화번호: 75805 519-685-8500
- 이메일: radhika.kelkar@lhsc.on.ca
연구 연락처 백업
- 이름: Mervin Blair, PhD, C.Psych
- 전화번호: 48170 519-646-6100
- 이메일: mervin.blair@sjhc.london.on.ca
연구 장소
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Ontario
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London, Ontario, 캐나다, N6C 0A7
- 모병
- St. Joseph's Health Care London, Parkwood Institute Mental Health Care Building
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연락하다:
- Radhika Kelkar, MD
- 전화번호: 75805 519-685-8500
- 이메일: radhika.kelkar@lhsc.on.ca
-
연락하다:
- Mervin Blair, PhD, C.Psych
- 전화번호: 48170 519-646-6100
- 이메일: mervin.blair@sjhc.london.on.ca
-
수석 연구원:
- Radhika Kelkar, MD
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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:
- Adults aged 18 years or older.
- Current post-traumatic stress disorder (PTSD) and current major depressive disorder (MDD), confirmed by a structured diagnostic interview (e.g., MINI 6.0 using the PTSD and MDD modules).
- Minimum symptom severity at baseline: HAMD-17 score ≥14 (moderate depression) and/or PCL-5 score ≥33 (probable PTSD).
- On a stable pharmacologic and/or psychotherapeutic regimen for at least 4 weeks prior to baseline, and willing to maintain stability during the treatment phase, unless medically necessary.
- Capacity to provide informed consent and comply with study procedures and visits at St. Joseph's Health Care, London/Parkwood Institute.
- Sufficient English proficiency to complete consent and study assessments.
Exclusion Criteria:
- Neurologic or device-related risks, including seizure history, traumatic brain injury with loss of consciousness greater than 5 minutes, major neurologic illness, or metal/electronic implants contraindicated for transcranial magnetic stimulation.
- Psychiatric or substance-related risks, including current psychotic disorder, acute mania, diagnosis of Bipolar I or Bipolar II disorder, recent substance use disorder, or imminent suicide risk.
- Medical or medication-related risks, including unstable severe illness, high-risk medications, hearing impairment, unwillingness to use ear protection, or prior non-response to an adequate course of theta burst stimulation for the current depression/PTSD episode.
- Enrollment in another interventional trial.
- Inability to comply with the study schedule.
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 |
|---|---|
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실험적: Accelerated iTBS
Participants will receive active accelerated intermittent theta burst stimulation (iTBS).
Treatment will consist of six short stimulation sessions per day delivered over five consecutive days, for a total of 30 sessions.
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Accelerated intermittent theta burst stimulation, also called accelerated iTBS, is a non-invasive magnetic brain stimulation intervention.
Stimulation is delivered to the left dorsolateral prefrontal cortex using a transcranial magnetic stimulation system.
Participants receive six short sessions per day over five consecutive days.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Recruitment rate
기간: Study recruitment period, up to 12 months
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Recruitment rate will be assessed as the number of participants enrolled per month during the active recruitment period.
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Study recruitment period, up to 12 months
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Consent rate
기간: Study recruitment period, up to 12 months
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Consent rate will be assessed as the proportion of eligible individuals approached who provide informed consent.
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Study recruitment period, up to 12 months
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Treatment adherence
기간: Treatment Days 1 through 5
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Treatment adherence will be assessed as the percentage of scheduled accelerated iTBS sessions completed during the 5-day treatment course.
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Treatment Days 1 through 5
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Retention through Week 12 follow-up
기간: Baseline through Week 12
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Retention will be assessed as the proportion of enrolled participants who complete the Week 12 follow-up visit.
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Baseline through Week 12
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Adverse events
기간: Treatment Days 1 through Week 12
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Adverse events will be assessed as the proportion of participants who experience one or more adverse events during treatment and follow-up.
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Treatment Days 1 through Week 12
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Serious adverse events
기간: Treatment Days 1 through Week 12
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Serious adverse events will be assessed as the proportion of participants who experience one or more serious adverse events during treatment and follow-up.
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Treatment Days 1 through Week 12
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Discontinuations due to adverse events
기간: Treatment Days 1 through Week 12
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Tolerability will be assessed as the proportion of participants who discontinue accelerated iTBS because of adverse events.
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Treatment Days 1 through Week 12
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Participant satisfaction with accelerated iTBS
기간: Week 2, Week 5, and Week 12
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Participant satisfaction will be assessed using a 5-point Likert satisfaction rating scale.
Scores range from 1 to 5, with higher scores indicating greater satisfaction.
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Week 2, Week 5, and Week 12
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Participant feedback on accelerated iTBS
기간: Week 2, Week 5, and Week 12
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Participant feedback will be assessed using brief feedback questions about the accelerated iTBS treatment schedule and overall study experience.
Responses will be summarized descriptively.
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Week 2, Week 5, and Week 12
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Exploratory change in clinician-rated depression symptom severity measured by HAMD-17
기간: Baseline, Week 2, Week 5, and Week 12
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Clinician-rated depression symptom severity will be assessed using the Hamilton Depression Rating Scale-17.
Total scores range from 0 to 52, with higher scores indicating greater depression symptom severity.
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Baseline, Week 2, Week 5, and Week 12
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Exploratory change in self-reported depression symptom severity measured by PHQ-9
기간: Baseline, Week 2, Week 5, and Week 12
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Self-reported depression symptom severity will be assessed using the Patient Health Questionnaire-9.
Total scores range from 0 to 27, with higher scores indicating greater depression symptom severity.
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Baseline, Week 2, Week 5, and Week 12
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Exploratory change in self-reported PTSD symptom severity measured by PCL-5
기간: Baseline, Week 2, Week 5, and Week 12
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Self-reported PTSD symptom severity will be assessed using the PTSD Checklist for DSM-5.
Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
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Baseline, Week 2, Week 5, and Week 12
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Exploratory change in clinician-rated PTSD symptom severity measured by CAPS-5
기간: Baseline, Week 2, and Week 12
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Clinician-rated PTSD symptom severity will be assessed using the Clinician-Administered PTSD Scale for DSM-5.
Total symptom severity scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
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Baseline, Week 2, and Week 12
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Exploratory change in anxiety symptom severity measured by GAD-7
기간: Baseline, Week 2, Week 5, and Week 12
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Anxiety symptom severity will be assessed using the Generalized Anxiety Disorder-7 item Scale.
Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
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Baseline, Week 2, Week 5, and Week 12
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Exploratory change in cognitive function measured by MoCA
기간: Baseline, Week 2, Week 5, and Week 12
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Cognitive function will be assessed using the Montreal Cognitive Assessment.
Total scores range from 0 to 30, with higher scores indicating better cognitive function.
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Baseline, Week 2, Week 5, and Week 12
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Exploratory change in functioning and disability measured by WHODAS 2.0
기간: Baseline, Week 2, Week 5, and Week 12
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Functioning and disability will be assessed using the WHO Disability Assessment Schedule 2.0
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Baseline, Week 2, Week 5, and Week 12
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Exploratory change in quality of life measured by Q-LES-Q-SF
기간: Baseline, Week 2, Week 5, and Week 12
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Quality of life will be assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form.
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Baseline, Week 2, Week 5, and Week 12
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Baseline clinical global severity measured by CGI-S
기간: Baseline
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Clinical global severity will be assessed using the Clinical Global Impression-Severity scale.
Scores range from 1 to 7, with higher scores indicating greater illness severity.
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Baseline
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Exploratory change in clinical global improvement measured by CGI-I
기간: Week 2, Week 5, and Week 12
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Clinical global improvement will be assessed using the Clinical Global Impression-Improvement scale.
Scores range from 1 to 7, with lower scores indicating greater clinical improvement.
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Week 2, Week 5, and Week 12
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Exploratory change in resting-state EEG alpha power
기간: Baseline, Treatment Day 1, and Treatment Day 5
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Resting-state EEG alpha power recorded at frontal electrodes will be assessed using EEG recordings collected at baseline and on treatment Days 1 and 5. On Days 1 and 5, brief resting-state EEG recordings will be collected immediately before and after each iTBS session to explore neurophysiological changes associated with accelerated iTBS.
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Baseline, Treatment Day 1, and Treatment Day 5
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Exploratory change in resting-state EEG gamma power
기간: Baseline, Treatment Day 1, and Treatment Day 5
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Resting-state EEG gamma power recorded at frontal electrodes will be assessed using EEG recordings collected at baseline and on treatment Days 1 and 5. On Days 1 and 5, brief resting-state EEG recordings will be collected immediately before and after each iTBS session to explore neurophysiological changes associated with accelerated iTBS.
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Baseline, Treatment Day 1, and Treatment Day 5
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Radhika Kelkar, MD, St. Joseph's Health Care London, Parkwood Institute, Finch Family Mental Health Care Building
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 9월 1일
기본 완료 (추정된)
2027년 6월 1일
연구 완료 (추정된)
2027년 9월 1일
연구 등록 날짜
최초 제출
2026년 6월 9일
QC 기준을 충족하는 최초 제출
2026년 6월 26일
처음 게시됨 (실제)
2026년 7월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 15일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- AiTBS-PTSD-MDD--001
- 127851 (기타 식별자: Western HSREB Project ID)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
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. .