RecruitingNot ApplicableNCT05224206

Neural Mechanisms of Intermittent Theta Burst Stimulation in the Core Depression Network


Sponsor

The Royal Ottawa Mental Health Centre

Enrollment

22 participants

Start Date

Apr 26, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Repetitive Transcranial magnetic stimulation (TMS) uses magnetic fields to modulate brain activity. A novel form of repetitive TMS (rTMS), intermittent theta burst stimulation (iTBS), has emerged as a promising new treatment for depression. This technique may be advantageous due to its very short duration and potentially stronger effect on brain activity in comparison with standard rTMS. However, the exact effect of iTBS on the activity of the brain in clinical populations remains poorly understood. This project aims to improve understanding of the mechanisms of action of iTBS by comparing its neuronal effect to sham treatment in 22 individuals with a diagnosis of major depressive episode, using positron emission tomography (PET) and magnetic resonance imaging (MRI) in a double-blind cross-over experiment, followed by a 6-week daily treatment course of iTBS.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how a type of brain stimulation called intermittent theta burst stimulation (iTBS) — a non-invasive treatment that uses magnetic pulses to stimulate specific brain areas — works to relieve treatment-resistant depression. The goal is to better understand how it changes brain activity. **You may be eligible if...** - You are between 18 and 55 years old - You have a confirmed diagnosis of major depressive disorder (MDD) - You have tried at least 1 but no more than 7 antidepressant medications at adequate doses without improvement - You are not currently in an acute medical crisis **You may NOT be eligible if...** - You have metal implants in your head or body that are not MRI-safe - You have a history of seizures or epilepsy - You are currently pregnant - You have a neurological disorder affecting the brain - You have a serious or unstable medical condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICETheta burst stimulation

Cool B65 active/placebo coil (left DLPFC) with X100 MagPro rTMS Device (Magventure A/S, Farum, Denmark)

DEVICETheta burst stimulation

Cool B70 coil (left DLPFC), with X100 MagPro rTMS Device (Magventure A/S, Farum, Denmark)


Locations(1)

The Royal Ottawa Mental Health Centre

Ottawa, Ontario, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05224206


Related Trials