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

5 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

20

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

  • Naam: Emma Cummings
  • Telefoonnummer: 6586 613-722-6521

Studie Locaties

    • Ontario
      • Ottawa, Ontario, Canada, K1Z 7K4
        • The Royal's Institute of Mental Health Research
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Repetitieve transcraniële magnetische stimulatie (rTMS) is een door Health Canada goedgekeurde behandeling voor ernstige depressie. Typische behandelingen omvatten dagelijkse sessies van 30 tot 45 minuten, verspreid over 4 tot 6 weken. Recente technische ontwikkelingen hebben de ontwikkeling mogelijk gemaakt van theta burst-stimulatie (TBS), een nieuw rTMS-paradigma dat dagelijkse sessies terugbrengt tot 3 tot 4 minuten, terwijl dezelfde klinische werkzaamheid behouden blijft. Deze studie zal specifiek intermitterende TBS (iTBS) toedienen, wat een nieuwe verfijning is van conventionele rTMS en bestaat uit bursts van 3 stimulaties bij 50 Hz en theta-frequentie (5 Hz).
Andere namen:
  • TMS
  • rTMS
  • TBS
  • iTBS

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Synaptic Density Following iTBS Measured by [¹⁸F]SynVesT-1 PET
Tijdsspanne: 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).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Resting-State Functional Connectivity Following accelerated iTBS
Tijdsspanne: 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).
Change in Cortical Neurochemistry Following iTBS
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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).

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Treatment-Emergent Adverse Events
Tijdsspanne: 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
Tijdsspanne: 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).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Sara Tremblay, The Royal's Institute of Mental Health Research
  • Hoofdonderzoeker: Lauri Tuominen, The Royal's Institute of Mental Health Research

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 augustus 2026

Primaire voltooiing (Geschat)

30 juli 2028

Studie voltooiing (Geschat)

30 juli 2028

Studieregistratiedata

Eerst ingediend

13 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 mei 2026

Eerst geplaatst (Werkelijk)

2 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

5 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

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-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • SAP

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op repetitieve transcraniële magnetische stimulatie

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