Deep TMS for Comorbid Depression and Cognitive Impairment in Older Adults

Rotman Research Institute at Baycrest

Status

Enrolling

Conditions

Alzheimer Disease

Major Depressive Disorder

Mild Cognitive Impairment

Treatments

Device: Brainsway H1-Coil Deep TMS System

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03665831

CICP-2-00095

Details and patient eligibility

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.

Full description

This study is an open-label trial to evaluate the safety and efficacy of H1-coil dTMS in treating depression in MCI and mild AD patients over 60 years of age who have not tolerated or failed to respond to antidepressant medications. 28 patients will be assigned to receive 4 consecutive weeks of daily active dTMS treatment. The long-term effects of treatment on emotional cognitive measures will be assessed at a 4-week follow-up visit (8 weeks from baseline). Symptom change and remission criteria will be assessed using the Montogmery-Asberg Depression Rating Scale (MADRS). Cognition will be assessed using a validated neuropsychological battery.

We will also offer patients to receive 4 weeks of treatment using theta-burst TMS, which is a milder version of TMS.

Enrollment

28 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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