Deep TMS to help thinking in older adults with mild cognitive decline

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 open-label, parallel pilot assigns participants aged 60–90 to one of three dTMS H-coils (H1, H4, H7) and delivers a six-week course of 20 stimulation sessions. Feasibility and tolerability are measured with side-effect checklists and mental-health questionnaires, while cognition is measured with neuropsychological tests and CNS Vital Signs and brain activity is recorded with EEG at baseline, midpoint, end point, and follow-up. Self-report mood and sleep questionnaires are collected at the same timepoints to capture noncognitive effects. The trial will compare absolute and differential tolerability across coils to provide preliminary data for a future randomized sham-controlled trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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's running

• Peter Boris Centre for Addictions Research, St. Joseph's Healthcare Hamilton
  Hamilton, Ontario, Canada Recruiting

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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.