Status:

RECRUITING

dTMS for Subjective Cognitive Decline

Lead Sponsor:

Rotman Research Institute at Baycrest

Collaborating Sponsors:

Brainsway

Centre for Addiction and Mental Health

Conditions:

Alzheimer Disease

Subjective Cognitive Decline

Eligibility:

All Genders

55-70 years

Phase:

NA

Brief 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 ...

Detailed Description

This study will examine the effects of combining cognitive remediation with neurostimulation using deep transcranial magnetic stimulation (dTMS) and the H7-coil to target the anterior cingulate cortex...

Eligibility Criteria

Inclusion

  • have a family history of late onset sporadic Alzheimer's disease (AD) as defined by having a first degree relative, living or deceased, with a probable or confirmed diagnosis of AD
  • 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 are not expected to change medication during the entire study period (if they are taking medications)
  • have a satisfactory safety screening questionnaire for TMS
  • have an informant/study partner who is able to complete study questionnaires regarding the participant

Exclusion

  • have a metal plate in their head, except in the mouth (such as an ear implant, implanted brain stimulators, aneurysm clips)
  • have known increased pressure or a history of increased pressure in their brain, which may increase their risk for having seizures
  • have a cardiac pacemaker
  • have an implanted medication pump
  • have a central venous line
  • have a significant heart condition
  • have current depression or a history of any psychotic disorder, bipolar disorder, eating disorder, obsessive compulsive disorder, post-traumatic stress disorder, or dementia other than AD
  • have a history of substance abuse in the last 6 months
  • have a history of stroke or other brain lesions
  • have a personal history of epilepsy
  • have a family history of epilepsy
  • are a pregnant or breast-feeding woman
  • have a history of abnormal MRI of the brain
  • have significant hearing loss requiring use of hearing aids
  • have untreated hypo- or hyper-thyroidism
  • have TMS contraindications
  • have unstable medical condition(s)
  • regularly use benzodiazepines or other hypnotics within 2 weeks of randomization

Key Trial Info

Start Date :

November 15 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

November 15 2026

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT06095063

Start Date

November 15 2023

End Date

November 15 2026

Last Update

October 27 2025

Active Locations (1)

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1

Rotman Research Institute at Baycrest

Toronto, Ontario, Canada, M6A 2E1