Feasibility and Tolerability of Deep Repetitive Transcranial Magnetic Stimulation for Mild Neurocognitive Disorder in Older Adults (Deep MIND): Study Protocol
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Background
Mild neurocognitive disorder (NCD) is a condition in which individuals experience mild cognitive decline but are independent in their activities of daily living. Due to the increasing number of people living with mild NCD and its negative impact on the quality of life, it poses a significant health burden worldwide. Thus, it warrants an urgent need for innovative approaches to address the lack of effective treatment options. Deep transcranial magnetic stimulation (dTMS), a non-invasive neuromodulation technique approved for the treatment of various neuropsychiatric disorders, could serve as a novel intervention for mild NCD. It can stimulate deeper and broader areas of the brain implicated in mild NCD, such as the prefrontal cortex, insula, and anterior cingulate cortex.
Objectives
This study will examine the feasibility and tolerability of the Health Canada and Food and Drug Administration (FDA) approved dTMS coils (H1, H4 and H7 coils) in individuals with mild NCD. Secondarily, it will assess the impact of dTMS on cognition, mood, sleep, anxiety, brain activity (via electroencephalography), and blood biomarkers of neurodegeneration and inflammation.
Methods
This open-label pilot study will recruit a total of N=30 participants between the ages of 60-90 with mild NCD. Participants will be assigned to one of the three dTMS coil conditions (H1, H4 & H7) and will complete a total of 20 dTMS sessions over 6 weeks. Data will be collected before, during, immediately after, and one-month following the intervention period.
Discussion
This pilot study will generate necessary evidence regarding the feasibility and tolerability of dTMS in mild NCD. This will be used to determine whether a definitive trial is justified and inform the trial procedures. In the long term, dTMS may address a critical gap in therapeutic options for mild NCD.
Clinical Trial registration
The protocol was registered on Clinicaltrials.gov (CT07038798) on June 2 nd , 2025.
