dTMS for Subjective Cognitive Decline

NCT06095063 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-10-27

No results posted yet for this study

Summary

Deep transcranial magnetic stimulation (dTMS) is a brain stimulation technique that involves generating a brief magnetic field in a coil that is placed on the scalp. The magnetic field passes through the skull and induces a weak electrical current in the brain that briefly activates neural circuits at the stimulation site. The Brainsway dTMS H7-Coil is able to target an area of the brain that has been shown in studies to be linked to greater resilience to cognitive decline. In this study, the investigators will combine dTMS with cognitive training in older adults with subjective cognitive decline (SCD) and examine the effect of this treatment on memory, other cognitive abilities, and mood. In addition, the investigators will examine the combined effects of dTMS and cognitive training on brain activity as measured using electroencephalography (EEG).

Approximately 30 older adults from ages 55 to 70 with SCD and a positive family history of Alzheimer's disease will be enrolled in this study.

Conditions

  • Alzheimer Disease
  • Subjective Cognitive Decline

Interventions

DEVICE

Active Brainsway H7-Coil Deep TMS System

Deep 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 daily for 4 consecutive weeks.

DEVICE

Sham Brainsway H7-Coil Deep TMS System

In addition to the active H-coil, a sham coil is included in the system. The active and sham coils are connected to a control switch, which alternates between real and sham operation modes. The sham treatment will be administered daily for 4 consecutive weeks.

OTHER

Cognitive Training

Cognitive training will be conducted using the BrainHQ software program.

Sponsors & Collaborators

  • Brainsway

    collaborator INDUSTRY
  • Centre for Addiction and Mental Health

    collaborator OTHER
  • Rotman Research Institute at Baycrest

    lead OTHER

Principal Investigators

  • Linda Mah · Baycrest Rotman Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
55 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-15
Primary Completion
2026-10-01
Completion
2026-11-15
FDA Device
Yes

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 NCT06095063 on ClinicalTrials.gov