NCT03665831Recruiting
Deep TMS for Comorbid Depression and Cognitive Impairment in Older Adults
Treatment of Comorbid Depression and Cognitive Impairment in Older Adults With Neurocognitive Disorders Using Deep Transcranial Magnetic Stimulation (dTMS)
Source: ClinicalTrials.gov · Last updated 27 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- First submitted
- 7 Sept 2018
- Start date
- 23 Oct 2018
- Primary completion date
- 15 Aug 2026
- Lead sponsor
- Rotman Research Institute at Baycrest
- Diseases
- Depression, Alzheimer disease
- NCT number
- NCT03665831
What you commit to
- Study type: Interventional
- Planned participants: 28
- From 23 Oct 2018 to the primary completion date, 15 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- have a metal plate in their head, except in the mouth (such as an ear implant, implanted brain stimulators, aneurysm clips)
- have an implanted medication pump
Other illness
- 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 a significant heart disease or history of stroke
- 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 taking psychotropic medications including antidepressant medications, antipsychotics or mood stabilizing medications due to increased risk of seizure
- have a history of abnormal MRI of the brain
Other
- have a central venous line
- Modified Hachinski Score (MHIS) \> 3 (to exclude those with significant vascular component to memory loss)
- are a pregnant or breast-feeding woman
- are taking memantine
- have significant hearing loss requiring use of hearing aids
- have untreated hypo- or hyper-thyroidism
Who the study is looking for
- 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
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rotman Research Institute at Baycrest Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.