RecruitingRecruiting
dTMS for Subjective Cognitive Decline
NCT06095063 · Rotman Research Institute at Baycrest
In plain English
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Official title
Effect of Deep Transcranial Magnetic Stimulation (dTMS) on Cognition in Older Adults With Subjective Cognitive Decline (SCD)
About this study
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 (ACC) in older adults at risk for developing Alzheimer's disease (AD). Thirty older adults with subjective cognitive decline (SCD) and a family history of AD will participate in a single-site randomized double-blind sham-controlled cross-over trial of dTMS of the ACC in conjunction with active cognitive remediation for both sham and dTMS interventions. The primary goal of the study is to establish the feasibility of dTMS and cognitive training as a means to improve cognitive abilities in SCD. Secondary goals are to obtain preliminary evidence of improvement in executive function and memory abilities following dTMS and cognitive training. This trial is a first step towards developing effective neurostimulation protocols to reduce cognitive decline in older adults at risk for developing AD.
Eligibility criteria
Inclusion Criteria:
* 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 Criteria:
* 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
Study design
Enrollment target: 30 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2023-11-15
Estimated completion: 2026-11-15
Last updated: 2025-10-27
Interventions
Device: Active Brainsway H7-Coil Deep TMS SystemDevice: Sham Brainsway H7-Coil Deep TMS SystemOther: Cognitive Training
Primary outcomes
- • Percentage of scheduled treatment sessions that are attended by study participants (19 weeks)
Sponsor
Rotman Research Institute at Baycrest · other
With: Brainsway, Centre for Addiction and Mental Health
Contacts & investigators
ContactAmanda Rahmadian · contact · dtms@research.baycrest.org · 416-785-2500
ContactLinda Mah · contact · preventad@research.baycrest.org · 416-785-2500
InvestigatorLinda Mah · principal_investigator, Baycrest Rotman Research Institute
All locations (1)
Rotman Research Institute at BaycrestRecruiting
Toronto, Ontario, Canada