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RECRUITING
NCT07038798
NA

Deep rTMS for Mild Neurocognitive Disorder in Older Adults

Sponsor: St. Joseph's Healthcare Hamilton

View on ClinicalTrials.gov

Summary

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.

Official title: Feasibility and Tolerability of Deep Repetitive Transcranial Magnetic Stimulation for Mild Neurocognitive Disorder in Older Adults: A Pilot Study (DeepMIND)

Key Details

Gender

All

Age Range

60 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-08-26

Completion Date

2027-01

Last Updated

2025-10-06

Healthy Volunteers

No

Interventions

DEVICE

Brainsway H1-Coil Deep TMS System

Participants assigned to this arm will complete a 6-week course of 20 dTMS stimulation session using the Brainsway H1-coil.

DEVICE

Brainsway H4-Coil Deep TMS System

Participants assigned to this arm will complete a 6-week course of 20 dTMS stimulation session using the Brainsway H4-coil.

DEVICE

Brainsway H7-Coil Deep TMS System

Participants assigned to this arm will complete a 6-week course of 20 dTMS stimulation session using the Brainsway H7-coil.

Locations (1)

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

Hamilton, Ontario, Canada