Actively Recruiting

Phase Not Applicable
Age: 55Years - 70Years
All Genders
ID06095063

Effect of Deep Transcranial Magnetic Stimulation (dTMS) on Cognition in Older Adults With Subjective Cognitive Decline (SCD)

Led by Rotman Research Institute at Baycrest · Updated on 2025-10-27

30

Participants Needed

1

Research Sites

6 weeks

Total Duration

On this page

Sponsors

R

Rotman Research Institute at Baycrest

Lead Sponsor

B

Brainsway

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of combining deep transcranial magnetic stimulation (dTMS) with cognitive training on memory, other cognitive abilities, and mood in older adults with subjective cognitive decline (SCD) who have a family history of Alzheimer's disease. This study is a randomized, double-blind, sham-controlled crossover trial aiming to explore the feasibility and preliminary effects of these treatments on cognitive function and brain activity measured by electroencephalography (EEG). Participants will undergo daily sessions of dTMS using the Brainsway H7-Coil targeting the anterior cingulate cortex, followed immediately by 20 to 30 minutes of computerized cognitive training with BrainHQ software. The dTMS intensity will be gradually increased over the first week to about 120% of the motor threshold, based on individual tolerance. The trial includes both active dTMS and sham stimulation groups, each followed by cognitive training, with treatment delivered over four consecutive weeks. During the 19-week study period, participants will attend scheduled treatment sessions and undergo assessments of memory, executive function, and mood using standardized neuropsychological tests and scales such as the Geriatric Depression Scale and Geriatric Anxiety Inventory. Brain activity changes will be monitored through EEG. Researchers will also look at treatment session attendance rates and safety. The total study duration includes baseline, treatment, and follow-up evaluations to measure the effects of the combined interventions.

CONDITIONS

Brief Title

dTMS for Subjective Cognitive Decline

Who Can Participate

Age: 55Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have a family history of late onset sporadic Alzheimer's disease with a first degree relative diagnosed
  • Have subjective memory decline and concern about memory changes
  • Score 26 or higher on the Montreal Cognitive Assessment (MoCA)
  • Are willing to provide informed consent
  • Are able to follow the treatment schedule
  • Are stable on medications for 2 months and not expected to change medications during the study
  • Have a satisfactory safety screening for TMS
  • Have an informant or study partner able to complete study questionnaires regarding the participant
Not Eligible

You will not qualify if you...

  • Have a metal plate in the head except in the mouth (such as ear implants, brain stimulators, aneurysm clips)
  • Have known or history of increased brain pressure increasing seizure risk
  • Have a cardiac pacemaker
  • Have an implanted medication pump
  • Have a central venous line
  • Have a significant heart condition
  • Have current depression or history of psychotic disorder, bipolar disorder, eating disorder, OCD, PTSD, or dementia other than Alzheimer's disease
  • Have history of substance abuse in last 6 months
  • Have history of stroke or brain lesions
  • Have personal or family history of epilepsy
  • Are pregnant or breastfeeding
  • Have history of abnormal brain MRI
  • Have significant hearing loss requiring hearing aids
  • Have untreated hypo- or hyper-thyroidism
  • Have contraindications for TMS
  • Have unstable medical conditions
  • Regularly use benzodiazepines or hypnotics within 2 weeks of randomization

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 4 weeks

Participants receive daily sessions of deep transcranial magnetic stimulation (dTMS) or sham stimulation followed by cognitive training using the BrainHQ software. Treatment is delivered over consecutive days targeting cognitive improvement.

20 treatment sessions (daily, in-person)

Implementation

Duration - 4 weeks

Participants receive daily sessions of sham dTMS followed by cognitive training using the BrainHQ software. Treatment is delivered over consecutive days targeting cognitive improvement.

20 treatment sessions (daily, in-person)

Trial Site Locations

Total: 1 location

1

Rotman Research Institute at Baycrest

Toronto, Ontario, Canada, M6A 2E1

Actively Recruiting

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Research Team

A

Amanda Rahmadian

L

Linda Mah

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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