Deep rTMS for Mild Neurocognitive Disorder in Older Adults

Recruiting now · Not applicable

Conditions studied: Mild Neurocognitive Disorder

In brief

This study aims to: (1) assess the feasibility and tolerability of three deep transcranial magnetic stimulation (dTMS) coils H1, H4, and H7 in older adults with mild neurocognitive disorder (mild NCD); and (2) evaluate changes in cognition through neuropsychological testing, brain activity through EEG, and mood and sleep through self-report questionnaires. Participants will be assigned to one of three arms: H1- coil vs. H4-coil vs. H7-coil, and all participants will complete assessments examining dTMS side effects, mental health symptoms, and cognition. EEG, questionnaires, and CNS vital signs will be measured at baseline, midpoint (after 10th session- before dTMS treatment on visit 11), and end point, as well as follow up. Collectively, the study will address the absolute and differential feasibility and tolerability of the H1, H4 and H7 coils to provide preliminary data for a future randomized controlled trial comparing this novel intervention to a sham stimulation (placebo) control.

Key facts

Study ID: NCT07038798
Run by: St. Joseph's Healthcare Hamilton
People needed: 30
Starts: 2025-08-26
Expected to finish: 2027-01-01
Last updated by the study team: 2025-10-06

Who can join

Age: 60 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

60 - 90 years old
Able to provide informed consent to participate in the study
Subjective concern of mild decline in cognitive function over the past year
Mild impairment in cognitive performance
Preserved independence in everyday activities
Independently mobile (e.g., participants must be able to get in and out of a chair on their own)
Participants will be required to be on stable dosages of other psychotropic medications for at least 4 weeks prior to screening

You may not qualify if…

Currently receiving treatment or subjective need for treatment for bipolar I or II disorder; psychotic disorder
Active suicidal behavior
Severe depression and/or anxiety
Other neurological or psychiatric disorders accounting for the cognitive deficits
Impairment in basic and/or instrumental activities of daily living
Substance use disorder (other than tobacco use disorder) in the past 3 months before entering the study
Traditional contraindications to rTMS: Intracranial or metal implants in the head or nearby regions, excluding the mouth, that cannot be safely removed; History of epilepsy or seizures; Active unstable medical condition (recent laboratory and neuroimaging alterations, delirium); Pacemaker and/or implantable cardioverter-defibrillators; current use of bupropion, treatment with equivalent benzodiazepine dose to lorazepam >2 mg/day
People with severe literacy, visual, or hearing issues that affect the ability to engage in the interviews
People with recurring migraines or headaches (weekly or more)
Frequent dizziness/vertigo
Individuals residing beyond the borders of the Greater Hamilton Area and its neighbouring vicinities

Where it is running

Peter Boris Centre for Addictions Research, St. Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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