Theta-Burst Stimulation to Treat Depression (NCT07033780)
Optimization of Prefrontal Theta-Burst Stimulation to Treat Depression: A Bench to First-in-Human Study
🩺 Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to explore the effects of non-invasive brain stimulation protocols using intermittent theta-burst stimulation (iTBS) on brain plasticity and depression severity in depressed individuals aged 18 to 50 years old. Brain plasticity is the brain's ability to change through growth or reorganization. iTBS is a form of transcranial magnetic stimulation (TMS), where magnetic pulses are applied to the scalp using a coil. These pulses pass through the scalp, and can alter brain activity in the area underneath the coil. Based on previous research conducted in animals and humans, researchers believe that iTBS can strengthen the connections between cells in the brain, leading to improved brain plasticity. This trial will compare the effects of the compressed iTBS (iTBS-c) protocol, which is commonly used to treat depression, and the spaced iTBS (iTBS-s) protocol. Researchers want to find out which protocol is better able to produce changes in brain plasticity and improve symptoms of depression among individuals diagnosed with Major Depressive Disorder (MDD). In this trial, participants will be randomized to receive 3 sessions of iTBS-s or iTBS-c, undergo a washout period of at least 2 weeks, then complete 3 sessions of the opposite iTBS intervention. Participants will complete 5 study visits within the span of 2-3 months, including: * Screening assessments to determine eligibility \& 1 sham iTBS (iTBS-sh) session to assess tolerability of the brain stimulation (Visit 1); * 1 Magnetic Resonance Imaging (MRI) brain scan and randomization (Visit 2); * Safety and clinical assessments, iTBS-s or iTBS-c intervention, TMS evoked electroencephalography (TMS-EEG) measurements, and post-iTBS questionnaires (Visits 3-5) followed by a washout period of at least 2 weeks; * Safety and clinical assessments, the opposite iTBS-s or iTBS-c intervention originally randomized to, TMS-EEG measurements, and post-iTBS questionnaires (Visits 6-8).
Who can join: Review the eligibility criteria below.
Location: Centre for Addiction and Mental Health — Toronto, Ontario
Age range: 18 Years to 50 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Centre for Addiction and Mental Health — Toronto, Ontario
📞 Contact the Study Coordinator
Phone: (416) 535-8501
Email: christoph.zrenner@camh.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Major Depressive Disorder (MDD)
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- Neuroimaging Markers of Midlife Depression and Cognitive Behavioural Therapy (CBT) — Toronto, Ontario
- Understanding the Role of the Kappa Opioid Receptor in Ketamine's Attenuation of Suicidal Thoughts — New York, New York
- Ketogenic Diet and Neuromodulation in Treatment Resistant Depression — Toronto, Ontario
- REWIRE: Real-world Engagement With Interventional and Rejoyn Effectiveness — Greenwich, Connecticut
- Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder — Toronto, Ontario
Explore by condition: All Major Depressive Disorder (MDD) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.