Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
NCT03665831

Deep TMS for Comorbid Depression and Cognitive Impairment in Older Adults

Led by Rotman Research Institute at Baycrest · Updated on 2025-10-27

28

Participants Needed

1

Research Sites

412 weeks

Total Duration

On this page

Sponsors

R

Rotman Research Institute at Baycrest

Lead Sponsor

B

Brainsway

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Deep TMS for Comorbid Depression and Cognitive Impairment in Older Adults

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Meet DSM 5 criteria for Major or Mild Neurocognitive Disorder due to Alzheimer's disease with Clinical Dementia Rating Scale score of at least 0.5
  • Diagnosed with DSM5 Major Depressive Disorder with current episode lasting longer than 4 weeks but less than 5 years
  • Did not respond to or did not tolerate antidepressant treatment
  • Willing to provide informed consent
  • Able to follow the treatment schedule
  • Stable on medications for 2 months and not expected to change medications during the study
  • Have a satisfactory safety screening questionnaire for TMS
  • Have an informant or study partner able to complete study questionnaires about the participant
Not Eligible

You will not qualify if you...

  • Have a metal plate in the head except in the mouth (e.g., ear implant, brain stimulators, aneurysm clips)
  • Have known or history of increased brain pressure raising seizure risk
  • Have a cardiac pacemaker
  • Have an implanted medication pump
  • Have a central venous line
  • Have significant heart disease or history of stroke
  • Modified Hachinski Score greater than 3
  • History of psychotic disorder, bipolar disorder, eating disorder, OCD, PTSD, or dementia other than Alzheimer's disease
  • History of substance abuse in the last 6 months
  • History of stroke or other brain lesions
  • Personal or family history of epilepsy
  • Are pregnant or breastfeeding
  • Taking psychotropic medications like antidepressants, antipsychotics, or mood stabilizers
  • Taking memantine
  • History of abnormal brain MRI
  • Significant hearing loss requiring hearing aids
  • Untreated hypo- or hyper-thyroidism

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Rotman Research Institute at Baycrest

Toronto, Ontario, Canada, M6A 2E1

Actively Recruiting

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Research Team

A

Amanda Rahmadian, BSc

CONTACT

L

Linda Mah, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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