Deep TMS treatment for depression and cognitive issues in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effects of deep repetitive transcranial magnetic stimulation (rTMS) using the H1 coil on older adults over 60 diagnosed with mild to early-moderate Alzheimer's disease or mild cognitive impairment, who also suffer from Major Depressive Disorder. Participants will receive 4 weeks of daily active dTMS treatment, with assessments of depression and cognitive function conducted before and after the treatment period. The study aims to determine the safety, efficacy, and long-term effects of this intervention on both emotional and cognitive measures.

Why it matters

Who can join: the full rules

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

Where it's running

• Rotman Research Institute at Baycrest
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Amanda Rahmadian, BSc
• Email: dtms@research.baycrest.org
• Phone: 416-785-2500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.