NCT03665831 · RECRUITING
Deep TMS for Comorbid Depression and Cognitive Impairment in Older Adults
This trial is testing whether a non-invasive brain stimulation device called deep TMS, using a specialized H1 coil aimed at the left prefrontal cortex, can relieve depression in adults over 60 who have both major depression and early Alzheimer's disease or mild cognitive impairment, and who have not responded to antidepressants. It is a Phase NA study, meaning it is a feasibility or pilot investigation rather than a large efficacy trial.
You may qualify if
- 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
You're excluded if
- 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-10-27