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