Deep TMS for Comorbid Depression and Cognitive Impairment in Older Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorRotman Research Institute at Baycrest
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Brainsway H1-Coil Deep TMS System
Treatment groups
28 Participants
are divided into 1 treatment groupSponsors and collaborators
Rotman Research Institute at Baycrest
Lead sponsor
Brainsway
Collaborator
Centre for Addiction and Mental Health
Collaborator
Source ClinicalTrials.gov