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Recruiting NCT03665831

Deep TMS for Comorbid Depression and Cognitive Impairment in Older Adults

Trial Parameters

Condition Major Depressive Disorder
Sponsor Rotman Research Institute at Baycrest
Study Type INTERVENTIONAL
Phase N/A
Enrollment 28
Sex ALL
Min Age 60 Years
Max Age N/A
Start Date 2018-10-23
Completion 2026-08-15
Interventions
Brainsway H1-Coil Deep TMS System

Brief Summary

In this study, the investigators will be examining the effects of the deep repetitive transcranial magnetic stimulation (rTMS) using the H1 coil in patients over the age of 60 diagnosed with mild to early-moderate Alzheimer's disease (AD) or mild cognitive impairment (MCI) and comorbid Major Depressive Disorder (MDD) who have been unable to tolerate or failed to respond to antidepressant medications. The coil was designed to stimulate deeper regions of the left dorsolateral prefrontal cortex (DLPFC). Based on prior research, the investigators propose that active stimulation with the H1 coil for 4 weeks may result in significant remission rates and will be tolerable and safe.

Eligibility Criteria

Inclusion Criteria: * meet DSM 5 criteria for Major or Mild Neurocognitive Disorder due to Alzheimer's disease with Clinical Dementia Rating Scale (CDR) score of at least 0.5 * have been diagnosed with DSM5 Major Depressive Disorder, with the current episode longer than 4 weeks but less than 5 years * did not respond to or did not tolerate antidepressant treatment * are willing to provide informed consent * are able to follow the treatment schedule * are stable on medications for 2 months and are not expected to change medication during the entire study period (if they are taking medications) * have a satisfactory safety screening questionnaire for TMS * have an informant/study partner who is able to complete study questionnaires regarding the participant Exclusion Criteria: * have a metal plate in their head, except in the mouth (such as an ear implant, implanted brain stimulators, aneurysm clips) * have known increased pressure or a history of increased pressure in their brain, which

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