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Deep rTMS for Mild Neurocognitive Disorder in Older Adults

NCT07038798 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-10-06

No results posted yet for this study

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.

Conditions

  • Mild Neurocognitive Disorder

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.

Sponsors & Collaborators

  • St. Joseph's Healthcare Hamilton

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-26
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07038798 on ClinicalTrials.gov