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

Sponsor
The Royal Ottawa Mental Health Centre
Study ID
NCT07620288
Status
Not Yet Recruiting

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Conditions

  • Depression
  • Depression - Major Depressive Disorder
  • Depressive Episode
  • Major Depressive Disorder (MDD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • repetitive Transcranial Magnetic Stimulation — DEVICE
    Repetitive transcranial magnetic stimulation (rTMS) is a Health Canada approved treatment for major depression. Typical treatments involve 30 to 45 minutes daily sessions delivered over 4 to 6 weeks. Recent technical advances allowed the development of theta burst stimulation (TBS), a novel rTMS paradigm that reduces daily sessions to 3 to 4 minutes while maintaining the same clinical efficacy. This study will specifically be administering intermittent TBS (iTBS), which is a novel refinement of conventional rTMS and consists of bursts of 3 stimulations at 50 Hz at theta frequency (5 Hz).

Study Details

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.

Key Dates

First listed
Jun 2, 2026
Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Jul 30, 2028
Completion
Jul 30, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Change in Synaptic Density Following iTBS Measured by [¹⁸F]SynVesT-1 PET [ Time Frame: Administered at baseline (prior to first iTBS treatment), and after the iTBS treatment course (i.e. one week later). ]

Central Contacts

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