- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Stacey Shim
- Numero di telefono: 6356 613-722-6521
- Email: rtms@theroyal.ca
Backup dei contatti dello studio
- Nome: Emma Cummings
- Numero di telefono: 6586 613-722-6521
Luoghi di studio
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Ontario
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Ottawa, Ontario, Canada, K1Z 7K4
- The Royal's Institute of Mental Health Research
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Contatto:
- Sara Tremblay, PhD
- Numero di telefono: 6227 613-722-6521
- Email: Sara.Tremblay@theroyal.ca
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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La stimolazione magnetica transcranica ripetitiva (rTMS) è un trattamento approvato da Health Canada per la depressione maggiore.
I trattamenti tipici prevedono sessioni giornaliere da 30 a 45 minuti erogate in 4-6 settimane.
I recenti progressi tecnici hanno consentito lo sviluppo della stimolazione theta burst (TBS), un nuovo paradigma rTMS che riduce le sessioni giornaliere a 3-4 minuti mantenendo la stessa efficacia clinica.
Questo studio somministrerà specificamente TBS intermittente (iTBS), che è un nuovo perfezionamento della rTMS convenzionale e consiste in raffiche di 3 stimolazioni a 50 Hz a frequenza theta (5 Hz).
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Synaptic Density Following iTBS Measured by [¹⁸F]SynVesT-1 PET
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Resting-State Functional Connectivity Following accelerated iTBS
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Incidence of Treatment-Emergent Adverse Events
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Investigatori
- Investigatore principale: Sara Tremblay, The Royal's Institute of Mental Health Research
- Investigatore principale: Lauri Tuominen, The Royal's Institute of Mental Health Research
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Primo Inserito (Effettivo)
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Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 0383
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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.
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- LINFA
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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