The goal of this clinical trial is to test whether an accelerated deep Transcranial Magnetic Stimulation (dTMS) protocol in combination with cognitive training can improve cognitive abilities in older adults with Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI). The study will look at whether it is safe and tolerable to use accelerated dTMS to enhance the benefits of cognitive training in older adults, and will also gather early information on the effects of accelerated dTMS on memory and other cognitive abilities.
55 - 85 years of age (on the day of randomization)
are male or post-menopausal female
have a diagnosis of mild cognitive impairment (MCI) based on Montreal Cognitive Assessment score < 26 or where available, results from clinical neuropsychological assessment, OR subjective memory concerns and first degree relative, living or deceased, with a probable or confirmed diagnosis of AD
score 24 or higher on the Mini Mental State Examination (MMSE)
have a metal plate in their head(such as an ear implant, implanted brain stimulators, aneurysm clips). Dental devices and implants that are non-magnetic are safe.
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
Parallel
Active Brainsway H7-Coil Deep TMS System
DeviceDeep Transcranial Magnetic Stimulation (dTMS) is a new form of TMS which allows direct stimulation of deeper neuronal pathways than the standard TMS. The H-coil is a novel dTMS coil designed to allow deeper brain stimulation without a significant increase of electric fields induced in superficial cortical regions. dTMS will be administered 6-8 times a day for 2-5 consecutive days.
Sham Brainsway H1-Coil Deep TMS System
DeviceIn addition to the active H7-coil, a sham coil is included in the H1-coil helmet.The sham treatment will be administered using the H1-coil helmet 6-8 times a day for 2-5 consecutive days.
Percentage of dTMS sessions attended by participants
Incidence and type of of adverse events experienced during treatment (participant-reported tolerability) based on the Adverse Events Questionnaire (AEQ)
The AEQ asks about symptoms related immediately after TMS administration where patients rate symptom severity from 1 (absent) to 4 (severe) and whether they believe it is related to TMS from 1 (no) to 5 (definitely).
The number of participants who prematurely withdraw and reasons for withdrawal
Change from baseline memory scores on computerized neuropsychological battery following the final session on day 5
Memory score from memory tests in the neuropsychological battery at baseline will be compared to after 5 days of TMS and after 6 weeks of cognitive training the active intervention group compared to the sham. A higher memory score indicates better memory performance. An effect size (Cohen's d) of 0.5 will be considered a minimally important effect size.
The change in baseline in scores on the Geriatric Anxiety Inventory (GAI) following 5 days of dTMS
The GAI is a 20-item self-report measure of anxiety developed for older adults. Administration time is approximately 5 minutes. The GAI scores range from 0-20, with higher scores indicating more anxiety.
The change in resting state activity as measured with electroencephalography (EEG) following 5 days of dTMS
The change in slow wave activity in the posterior default mode network (posterior cingulate cortex) as measured with MEG following 5 days of dTMS
The change in functional connectivity within the default mode network based on Magnetic Resonance Imaging (MRI) following 5 days of dTMS
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