- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07620288
Comparing Outcomes of Theta Burst Stimulation in Depression Using Advanced PET Imaging
Measuring Neuroplasticity Outcomes of Theta Burst Stimulation in Depression Using Advanced PET Imaging
연구 개요
상세 설명
Major depressive disorder (MDD) is one of the most prevalent and disabling disorders worldwide, affecting approximately one in 20 Canadians at any given time and ranking among the leading causes of lost productivity, poor quality of life, and suicide. Despite major advances in pharmacological and psychotherapeutic interventions, only 40-60% of patients respond to first-line treatments. Theta Burst Stimulation (TBS) represents the next generation of rTMS technology: by delivering patterned bursts of magnetic pulses that mimic intrinsic theta-gamma coupling, TBS is thought to more efficiently engage synaptic plasticity mechanisms that underlie mood regulation. Clinically, iTBS achieves antidepressant efficacy comparable to conventional 10 Hz rTMS in one-tenth of the stimulation time, enabling faster, more accessible treatments. Yet, despite its growing clinical use and regulatory approval in multiple countries, the fundamental mechanisms by which iTBS modulates limbic-cortical networks to alleviate depressive symptoms remain poorly understood. Addressing this knowledge gap is essential to optimizing treatment protocols and advancing precision neuromodulation strategies.
Understanding how iTBS drives recovery thus requires moving beyond traditional symptom-based approaches toward multi-level indices of brain plasticity that capture functional, neurochemical, and microstructural change. Current evidence remains largely descriptive, with limited direct insight into the underlying synaptic or cellular mechanisms of iTBS-induced modulation. Integrating PET with high-resolution MRI techniques provides a unique window on these processes. We now have full capacity for in-house synthesis and imaging with [F18]SynVesT-1. Thus, this tracer quantifies synaptic density in vivo, providing a direct molecular measure of plasticity. The ability to pair [F18]SynVesT-1 PET simultaneously with MRI represents a transformative advance for mechanistic neuromodulation research.
Clinical trials show that accelerated TBS, individually targeted to the DLPFC region most anti-correlated to sgACC, can produce rapid symptom relief within days rather than weeks. However, the neurobiological mechanisms underlying these effects remain unknown. It is hypothesized that repeated stimulation sessions promote cumulative synaptic potentiation and large-scale network reorganization. Elucidating these processes is crucial to optimize dosing parameters, understand inter-individual variability in response, and guide the next generation of biologically informed treatment strategies.
The proposed project will investigate the neurobiological mechanisms of accelerated TBS in MDD using an advanced multimodal imaging approach. In this single-arm, within-subject study, participants will undergo one week of accelerated iTBS treatment while completing pre- and post-treatment positron emission tomography (PET) and magnetic resonance imaging (MRI). PET imaging with the synaptic vesicle tracer [¹⁸F]SynVesT-1 will quantify changes in synaptic density, while MRI sequences such as resting-state functional MRI, magnetic resonance spectroscopy, and neurite orientation dispersion and density imaging (NODDI) will assess functional connectivity and microstructural plasticity. By integrating molecular, functional, and structural measures of brain plasticity, the study will provide new insight into how accelerated iTBS alters brain circuits implicated in depression and how these changes relate to clinical improvement.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Stacey Shim
- 전화번호: 6356 613-722-6521
- 이메일: rtms@theroyal.ca
연구 연락처 백업
- 이름: Emma Cummings
- 전화번호: 6586 613-722-6521
연구 장소
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Ontario
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Ottawa, Ontario, 캐나다, K1Z 7K4
- The Royal's Institute of Mental Health Research
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연락하다:
- Sara Tremblay, PhD
- 전화번호: 6227 613-722-6521
- 이메일: Sara.Tremblay@theroyal.ca
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria
For inclusion in the study, participants must fulfill all the following criteria:
- 18 to 55 years old.
- Competent to provide voluntary informed consent.
- English comprehension and verbal communication (participants must be able to both understand and speak English sufficiently to follow study procedures and be understood by study personnel
- Referred by their treating physician.
- Mini-International Neuropsychiatric Interview-confirmed diagnosis of MDD, as a single or recurring episode.
- Symptoms of MDD have not improved after ≥ 1 adequate antidepressant medication trial in the current depressive episode29.
- Baseline score of ≥18 on the 17-item Hamilton Rating Scale for Depression (HRSD-17).
- Maintained a stable treatment regimen for at least four weeks prior to entering the study, defined as being on a stable antidepressant regimen, a stable psychotherapy regimen, both, or neither (i.e., no treatment), with no changes during this period.
Exclusion Criteria
Participants fulfilling any of the following criteria will be excluded from the study:
- Any comorbid mental health disorders (including, but not limited to lifetime history of psychotic disorders, OCD, and/or bipolar I or II disorder) with the exception of anxiety/panic disorders, posttraumatic stress disorder and ADHD
- Current or past (< 3 months) substance (including nicotine) or alcohol abuse/dependence, as defined in DSM-5 criteria.
- Positive urine test for illegal substances, cannabis, or cotinine.
- Significant unstable medical or neurologic illness confirmed by medical history (e.g. uncontrolled diabetes, or renal dysfunction).
- Breastfeeding or pregnant (confirmed via urine test).
- BMI > 30 or BMI < 18.
- Contraindication for TMS (e.g., personal history of epilepsy or convulsion, metallic head implant, pacemaker).
- Contraindication for MRI (e.g. metallic implant, claustrophobia).
- Have received a cumulative radioactivity dose > 15.2mSv during the last 12 months.
- Have active malignancies (due to high chance of undergoing radiation therapy).
- Suicide attempt in the past three months and/or active suicidal intent.
- Failed (non-response) course of ECT or rTMS treatment in the current depressive episode.
- Benzodiazepine or lithium use. Other psychotropic medications (e.g. ADHD medications) are permitted, if stable in the 4 weeks prior to and during the treatment course)
- Any other condition that, in the opinion of the investigators, would adversely affect the participant's ability to complete the study.
공부 계획
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
One week of accelerated iTBS and use pre-/post-treatment PET/MRI to quantify changes in synaptic density, functional connectivity, and microstructural integrity.
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반복적 경두개 자기 자극(rTMS)은 캐나다 보건부가 승인한 주요 우울증 치료법입니다.
일반적인 치료에는 4~6주에 걸쳐 매일 30~45분 세션이 포함됩니다.
최근 기술 발전으로 인해 동일한 임상 효능을 유지하면서 일일 세션을 3~4분으로 줄이는 새로운 rTMS 패러다임인 세타 버스트 자극(TBS)이 개발되었습니다.
이 연구에서는 구체적으로 기존 rTMS를 새롭게 개선하고 세타 주파수(5Hz)에서 50Hz로 3회 자극 버스트로 구성된 간헐적 TBS(iTBS)를 관리하게 됩니다.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Synaptic Density Following iTBS Measured by [¹⁸F]SynVesT-1 PET
기간: Administered at baseline (prior to first iTBS treatment), and after the iTBS treatment course (i.e. one week later).
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We will quantify changes in synaptic density (expressed as non-displaceable binding potential (BPND)) within (a) the sgACC (primary ROI) and (b) the stimulated DLPFC (secondary ROI), with exploratory analyses in frontal, parietal and cerebellar regions identified in the seed dataset.
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Administered at baseline (prior to first iTBS treatment), and after the iTBS treatment course (i.e. one week later).
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Resting-State Functional Connectivity Following accelerated iTBS
기간: Administered at baseline (prior to first iTBS treatment) and after the iTBS treatment course (i.e. one week later).
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Resting-state functional MRI (rs-fMRI) will be used to assess changes in functional connectivity (Fisher z-transformed correlation coefficients) within fronto-limbic networks following accelerated iTBS.
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Administered at baseline (prior to first iTBS treatment) and after the iTBS treatment course (i.e. one week later).
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Correlation Between Changes in [18F]SynVesT-1 Binding and Depressive Symptom Improvement Following iTBS
기간: Administered at screening, before the first iTBS, mid-treatment course (i.e. treatment day 3, following treatment #15), after the iTBS treatment course (i.e. treatment day 5, following treatment #30), and 1-month post treatment course.
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This outcome will assess the correlation between pre-post changes in synaptic density, measured using [18F]SynVesT-1 positron emission tomography (PET) standardized uptake value ratio (SUVR), and changes in depressive symptom severity, measured using the 17-item Hamilton Rating Scale for Depression (HRSD-17) total score, following accelerated iTBS, with the outcome metric defined as the correlation coefficient between changes in [18F]SynVesT-1 PET SUVR values and HRSD-17 total scores.
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Administered at screening, before the first iTBS, mid-treatment course (i.e. treatment day 3, following treatment #15), after the iTBS treatment course (i.e. treatment day 5, following treatment #30), and 1-month post treatment course.
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Change in Cortical Neurochemistry Following iTBS
기간: Administered at baseline (prior to first iTBS treatment) and after the iTBS treatment course (i.e. one week later).
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Magnetic resonance spectroscopy (MRS) will be used to assess changes in cortical neurochemical metabolite concentrations or metabolite ratios (e.g., Glx, GABA+/Cr) following accelerated iTBS.
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Administered at baseline (prior to first iTBS treatment) and after the iTBS treatment course (i.e. one week later).
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Change in Cerebral Perfusion Following iTBS
기간: Administered at baseline (prior to first iTBS treatment) and after the iTBS treatment course (i.e. one week later).
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Arterial spin labelling (ASL) MRI will be used to assess changes in regional cerebral blood flow levels following accelerated iTBS.
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Administered at baseline (prior to first iTBS treatment) and after the iTBS treatment course (i.e. one week later).
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Change in Neurite Microstructure Following iTBS
기간: Administered at baseline (prior to first iTBS treatment) and after the iTBS treatment course (i.e. one week later).
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Neurite Orientation Dispersion and Density Imaging (NODDI) will be used to assess changes in neurite microstructure following accelerated iTBS, as measured by changes in neurite density index (NDI) and orientation dispersion index (ODI).
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Administered at baseline (prior to first iTBS treatment) and after the iTBS treatment course (i.e. one week later).
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Treatment-Emergent Adverse Events
기간: Daily Monday-Friday throughout treatment course (1 week).
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Adverse events will be tracked and recorded.
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Daily Monday-Friday throughout treatment course (1 week).
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Side Effects
기간: Daily Monday-Friday throughout study (1 week).
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Side effects will be tracked and recorded on any TMS visits, using the TMS side effects questionnaire.
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Daily Monday-Friday throughout study (1 week).
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sara Tremblay, The Royal's Institute of Mental Health Research
- 수석 연구원: Lauri Tuominen, The Royal's Institute of Mental Health Research
간행물 및 유용한 링크
일반 간행물
- Disner SG, Beevers CG, Haigh EA, Beck AT. Neural mechanisms of the cognitive model of depression. Nat Rev Neurosci. 2011 Jul 6;12(8):467-77. doi: 10.1038/nrn3027.
- Baeken C, Marinazzo D, Everaert H, Wu GR, Van Hove C, Audenaert K, Goethals I, De Vos F, Peremans K, De Raedt R. The Impact of Accelerated HF-rTMS on the Subgenual Anterior Cingulate Cortex in Refractory Unipolar Major Depression: Insights From 18FDG PET Brain Imaging. Brain Stimul. 2015 Jul-Aug;8(4):808-15. doi: 10.1016/j.brs.2015.01.415. Epub 2015 Feb 7.
- Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26.
- Cash RFH, Zalesky A, Thomson RH, Tian Y, Cocchi L, Fitzgerald PB. Subgenual Functional Connectivity Predicts Antidepressant Treatment Response to Transcranial Magnetic Stimulation: Independent Validation and Evaluation of Personalization. Biol Psychiatry. 2019 Jul 15;86(2):e5-e7. doi: 10.1016/j.biopsych.2018.12.002. Epub 2019 Jan 19. No abstract available.
- Tremblay S, Tuominen L, Zayed V, Pascual-Leone A, Joutsa J. The study of noninvasive brain stimulation using molecular brain imaging: A systematic review. Neuroimage. 2020 Oct 1;219:117023. doi: 10.1016/j.neuroimage.2020.117023. Epub 2020 Jun 5.
- Kang SG, Cho SE. Neuroimaging Biomarkers for Predicting Treatment Response and Recurrence of Major Depressive Disorder. Int J Mol Sci. 2020 Mar 20;21(6):2148. doi: 10.3390/ijms21062148.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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
기타 연구 ID 번호
- 0383
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
After participants have completed their participation, we will ask them for informed consent for the storage of their de-identified data on OpenNeuro (an open access database) for the purpose of unspecified research for unspecified future research.
If they do agree to participate, they will be given a unique study code (different from the participant ID used in the previous study) will be assigned to all of the study data instead of personal identifying information (ex. 'John Smith' replaced by the unique study code 'A283422'). This unique study code will be used in the Open Access database to ensure privacy and confidentiality (i.e. de-identified study data cannot be linked to participant in any way).
In addition to an unique study code, their de-identified study data used in the Open Access database will include: age, sex, handedness, education level, medical diagnosis, medication, summary scores from clinical interviews, and MRI scans.
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 수액
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. .
반복적인 경두개 자기 자극에 대한 임상 시험
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Hospital Center Guillaume Régnier모병
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Stanford UniversityNYU Langone Health; Wills Eye; Otto-von-Guericke University Magdeburg모집하지 않고 적극적으로
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The Mind Research NetworkUniversity of New Mexico모집하지 않고 적극적으로