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Comparing Outcomes of Theta Burst Stimulation in Depression Using Advanced PET Imaging

2026年5月27日 更新者:Sara Tremblay、The Royal Ottawa Mental Health Centre

Measuring Neuroplasticity Outcomes of Theta Burst Stimulation in Depression Using Advanced PET Imaging

The proposed project will investigate the neurobiological mechanisms of accelerated intermittent Theta Burst Stimulation (iTBS) in major depressive disorder (MDD) using an advanced multimodal imaging approach. This single-arm, within-subject study will deliver one week of accelerated iTBS and use pre-/post-treatment PET/MRI to quantify changes in synaptic density, functional connectivity, and microstructural integrity. We will combine [¹⁸F]SynVesT-1 PET with functional, neurochemical and anatomical MRI, such as resting-state fMRI, magnetic resonance spectroscopy (MRS) and neurite orientation dispersion and density imaging (NODDI), to capture treatment-related plasticity. This integrated design will link molecular and network-level mechanisms to clinical improvement, providing an unprecedented mechanistic map of how accelerated iTBS restores brain function in depression.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

20

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Stacey Shim
  • 電話番号:6356 613-722-6521
  • メールrtms@theroyal.ca

研究連絡先のバックアップ

  • 名前:Emma Cummings
  • 電話番号:6586 613-722-6521

研究場所

    • Ontario
      • Ottawa、Ontario、カナダ、K1Z 7K4
        • The Royal's Institute of Mental Health Research
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria

For inclusion in the study, participants must fulfill all the following criteria:

  1. 18 to 55 years old.
  2. Competent to provide voluntary informed consent.
  3. 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
  4. Referred by their treating physician.
  5. Mini-International Neuropsychiatric Interview-confirmed diagnosis of MDD, as a single or recurring episode.
  6. Symptoms of MDD have not improved after ≥ 1 adequate antidepressant medication trial in the current depressive episode29.
  7. Baseline score of ≥18 on the 17-item Hamilton Rating Scale for Depression (HRSD-17).
  8. 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:

  1. 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
  2. Current or past (< 3 months) substance (including nicotine) or alcohol abuse/dependence, as defined in DSM-5 criteria.
  3. Positive urine test for illegal substances, cannabis, or cotinine.
  4. Significant unstable medical or neurologic illness confirmed by medical history (e.g. uncontrolled diabetes, or renal dysfunction).
  5. Breastfeeding or pregnant (confirmed via urine test).
  6. BMI > 30 or BMI < 18.
  7. Contraindication for TMS (e.g., personal history of epilepsy or convulsion, metallic head implant, pacemaker).
  8. Contraindication for MRI (e.g. metallic implant, claustrophobia).
  9. Have received a cumulative radioactivity dose > 15.2mSv during the last 12 months.
  10. Have active malignancies (due to high chance of undergoing radiation therapy).
  11. Suicide attempt in the past three months and/or active suicidal intent.
  12. Failed (non-response) course of ECT or rTMS treatment in the current depressive episode.
  13. 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)
  14. Any other condition that, in the opinion of the investigators, would adversely affect the participant's ability to complete the study.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
反復経頭蓋磁気刺激 (rTMS) は、カナダ保健省で承認された大うつ病の治療法です。 一般的な治療には、毎日 30 ~ 45 分のセッションを 4 ~ 6 週間かけて実施します。 最近の技術の進歩により、同じ臨床効果を維持しながら、1 日のセッションを 3 ~ 4 分に短縮する新しい rTMS パラダイムであるシータ バースト刺激 (TBS) の開発が可能になりました。 この研究では特に、従来の rTMS を新たに改良した断続的 TBS (iTBS) を投与します。これは、シータ周波数 (5 Hz)、50 Hz での 3 回の刺激のバーストで構成されます。
他の名前:
  • TMS
  • rTMS
  • TBS
  • iTBS

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Synaptic Density Following iTBS Measured by [¹⁸F]SynVesT-1 PET
時間枠:Administered at baseline (prior to first iTBS treatment), and after the iTBS treatment course (i.e. one week later).
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.
Administered at baseline (prior to first iTBS treatment), and after the iTBS treatment course (i.e. one week later).

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Resting-State Functional Connectivity Following accelerated iTBS
時間枠:Administered at baseline (prior to first iTBS treatment) and after the iTBS treatment course (i.e. one week later).
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.
Administered at baseline (prior to first iTBS treatment) and after the iTBS treatment course (i.e. one week later).
Correlation Between Changes in [18F]SynVesT-1 Binding and Depressive Symptom Improvement Following iTBS
時間枠: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.
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.
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.
Change in Cortical Neurochemistry Following iTBS
時間枠:Administered at baseline (prior to first iTBS treatment) and after the iTBS treatment course (i.e. one week later).
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.
Administered at baseline (prior to first iTBS treatment) and after the iTBS treatment course (i.e. one week later).
Change in Cerebral Perfusion Following iTBS
時間枠:Administered at baseline (prior to first iTBS treatment) and after the iTBS treatment course (i.e. one week later).
Arterial spin labelling (ASL) MRI will be used to assess changes in regional cerebral blood flow levels following accelerated iTBS.
Administered at baseline (prior to first iTBS treatment) and after the iTBS treatment course (i.e. one week later).
Change in Neurite Microstructure Following iTBS
時間枠:Administered at baseline (prior to first iTBS treatment) and after the iTBS treatment course (i.e. one week later).
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).
Administered at baseline (prior to first iTBS treatment) and after the iTBS treatment course (i.e. one week later).

その他の成果指標

結果測定
メジャーの説明
時間枠
Incidence of Treatment-Emergent Adverse Events
時間枠:Daily Monday-Friday throughout treatment course (1 week).
Adverse events will be tracked and recorded.
Daily Monday-Friday throughout treatment course (1 week).
Side Effects
時間枠:Daily Monday-Friday throughout study (1 week).
Side effects will be tracked and recorded on any TMS visits, using the TMS side effects questionnaire.
Daily Monday-Friday throughout study (1 week).

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Sara Tremblay、The Royal's Institute of Mental Health Research
  • 主任研究者:Lauri Tuominen、The Royal's Institute of Mental Health Research

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月1日

一次修了 (推定)

2028年7月30日

研究の完了 (推定)

2028年7月30日

試験登録日

最初に提出

2026年5月13日

QC基準を満たした最初の提出物

2026年5月27日

最初の投稿 (実際)

2026年6月2日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月2日

QC基準を満たした最後の更新が送信されました

2026年5月27日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

Once data has been included in the OpenNeuro database, data cannot be removed or withdrawn as we will be unable to identify participant information to separate it from the database.

IPD 共有アクセス基準

The shared data will be hosted on the OpenNeuro (https://openneuro.org/) platform. The dataset becomes publicly available under the Creative Commons Zero (CC0) Public Domain Dedication which places no restrictions on who can use the data or what can be done with them. The OpenNeuro is supported by the United States National Institutes of Mental Health BRAIN Initiative. The OpenNeuro follows the FAIR principles, which states that in order for shared data to be maximally useful for the scientific community, they need to be Findable, Accessible, Interoperable, and Reusable.

IPD 共有サポート情報タイプ

  • SAP

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

反復的な経頭蓋磁気刺激の臨床試験

購読する