Phase
Condition
Mental Disability
Affective Disorders
Depression
Treatment
Brainsway H1-Coil Deep TMS System
Clinical Study ID
Ages > 60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
meet DSM 5 criteria for Major or Mild Neurocognitive Disorder due to Alzheimer'sdisease with Clinical Dementia Rating Scale (CDR) score of at least 0.5
have been diagnosed with DSM5 Major Depressive Disorder, with the current episodelonger 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 medicationduring 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 questionnairesregarding the participant
Exclusion
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 vascularcomponent to memory loss)
have a history of any psychotic disorder, bipolar disorder, eating disorder,obsessive compulsive disorder, post-traumatic stress disorder, or dementia otherthan 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
Study Description
Connect with a study center
Rotman Research Institute at Baycrest
Toronto, Ontario M6A 2E1
CanadaSite Not Available
Rotman Research Institute at Baycrest
Toronto 6167865, Ontario 6093943 M6A 2E1
CanadaActive - Recruiting

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