Recruiting

Deep TMS

Sponsor:

Rotman Research Institute at Baycrest

Code:

NCT03665831

Conditions

Major Depressive Disorder

Alzheimer Disease

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Brainsway H1-Coil Deep TMS System

Study Details

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.

Conditions

Major Depressive Disorder

Alzheimer Disease

Mild Cognitive Impairment

Study ID

NCT03665831

Start date

Oct 23, 2018

Status verified date

Apr, 2025

Completion date

Sep 15, 2026

Anticipated

Primary completion date

Aug 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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 may increase their risk for having seizures
  • have a cardiac pacemaker
  • have an implanted medication pump
  • have a central venous line
  • have a significant heart disease or history of stroke
  • Modified Hachinski Score (MHIS) > 3 (to exclude those with significant vascular component to memory loss)
  • have a history of any psychotic disorder, bipolar disorder, eating disorder, obsessive compulsive disorder, post-traumatic stress disorder, or dementia other than AD
  • have a history of substance abuse in the last 6 months
  • have a history of stroke or other brain lesions
  • have a personal history of epilepsy
  • have a family history of epilepsy
  • are a pregnant or breast-feeding woman
  • are taking psychotropic medications including antidepressant medications, antipsychotics or mood stabilizing medications due to increased risk of seizure
  • are taking memantine
  • have a history of abnormal MRI of the brain
  • have significant hearing loss requiring use of hearing aids
  • have untreated hypo- or hyper-thyroidism

Study Design

Enrollment

28 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active H1 Coil deep rTMS active treatment

Interventions

Brainsway H1-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 daily for 4 consecutive weeks.

Primary outcome measure

  • Change From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Amanda Rahmadian, BSc

416-785-2500dtms@research.baycrest.org

Linda Mah, MD

416-785-2500preventad@research.baycrest.org

Locations

Rotman Research Institute at Baycrest

Recruiting

Toronto, Ontario, Canada, M6A 2E1

Contacts

Linda Mah, MD, MHS, FRCPC

416-785-2500preventad@research.baycrest.org

More Information

Sponsor

Rotman Research Institute at Baycrest

Last update posted

Oct 27, 2025

Last verified

Apr, 2025

Keywords

  • dTMS
  • depression
  • magnetic
  • iTBS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rotman Research Institute at Baycrest on 2025-10-27.