Actively Recruiting

Phase Not Applicable
Age: 60Years - 90Years
All Genders
NCT07038798

Deep rTMS for Mild Neurocognitive Disorder in Older Adults

Led by St. Joseph's Healthcare Hamilton · Updated on 2025-10-06

30

Participants Needed

1

Research Sites

70 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Deep rTMS for Mild Neurocognitive Disorder in Older Adults

Who Can Participate

Age: 60Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 60 to 90 years
  • Able to provide informed consent
  • Subjective mild decline in cognitive function over the past year
  • Mild cognitive impairment
  • Independence in everyday activities
  • Independently mobile (able to get in and out of a chair)
  • Stable dosages of psychotropic medications for at least 4 weeks before screening
Not Eligible

You will not qualify if you...

  • Current treatment or need for treatment for bipolar I or II disorder or psychotic disorder
  • Active suicidal behavior
  • Severe depression or anxiety
  • Neurological or psychiatric disorders causing cognitive deficits
  • Impairment in basic or instrumental daily activities
  • Substance use disorder (except tobacco) in past 3 months
  • Contraindications to rTMS: intracranial or metal implants in the head or nearby areas that cannot be safely removed, history of epilepsy or seizures, unstable medical conditions, pacemaker or implantable cardioverter-defibrillators, current use of bupropion or high-dose benzodiazepines
  • Severe literacy, visual, or hearing issues affecting participation
  • Frequent migraines or headaches (weekly or more)
  • Frequent dizziness or vertigo
  • Living outside the Greater Hamilton Area or neighboring regions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peter Boris Centre for Addictions Research, St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada, L9C 0E3

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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