RecruitingNot ApplicableNCT07212465

Accelerated Neuromodulation of Anterior Cingulate Cortex for Depression

Feasibility, Tolerability, and Preliminary Efficacy for Non-Invasive Neuromodulation of the Anterior Cingulate Cortex for Depression (NACC-D) in Older Adults Using Deep Transcranial Magnetic Stimulation With an Accelerated Intermittent Theta Burst Protocol

Sponsor

Rotman Research Institute at Baycrest

Enrollment

24 participants

Start Date

Jul 21, 2025

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder (MDD)

Summary

The goal of this clinical trial is to test whether an accelerated deep Transcranial Magnetic Stimulation (dTMS) protocol can reduce depressive symptoms in older adults (ages 60-85) with Major Depressive Disorder (MDD) who have not tolerated or responded to antidepressant medications. The study will evaluate whether accelerated dTMS administered over 5 consecutive days is safe and well-tolerated in this population, and whether it produces greater reductions in depressive symptoms compared to placebo stimulation.

Eligibility

Min Age: 60 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests a fast, intensive course of repetitive transcranial magnetic stimulation (rTMS) — a non-invasive brain stimulation therapy — targeting a specific brain region called the anterior cingulate cortex, in older adults with depression that has not responded to medication. **You may be eligible if...** - You are between 60 and 85 years old - You have been diagnosed with major depressive disorder, with a current episode lasting more than 4 weeks but less than 5 years - You tried at least one antidepressant for at least 8 weeks without adequate relief - You are willing to follow the treatment schedule and have been on stable medications for at least 2 months - You have passed a safety screening for TMS **You may NOT be eligible if...** - You have a metal plate, implanted brain stimulator, or aneurysm clip in your head - You have a seizure disorder or other condition that makes TMS unsafe - You have not tried antidepressants previously - You are not in the 60–85 age range 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.

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Interventions

DEVICEActive Brainsway H7-Coil Deep TMS System

Deep Transcranial Magnetic Stimulation (dTMS) is a new form of TMS which allows direct stimulation of deeper neuronal pathways than the standard TMS. The H-coil is a novel dTMS coil designed to allow deeper brain stimulation without a significant increase of electric fields induced in superficial cortical regions. dTMS will be administered 6-8 times a day for 5 consecutive days.

DEVICESham Brainsway H1-Coil Deep TMS System

In addition to the active H7-coil, a sham coil is included in the H1-coil helmet. The sham treatment will be administered 6-8 times a day for 5 consecutive days.