Using deep brain stimulation and cognitive training to improve memory in older adults with cognitive decline

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of deep transcranial magnetic stimulation (dTMS) combined with cognitive training on older adults experiencing subjective cognitive decline (SCD) and at risk for Alzheimer's disease. Participants will undergo a randomized double-blind sham-controlled cross-over trial, where they will receive either active dTMS or a sham treatment alongside cognitive training. The primary goal is to assess the feasibility of this combined approach to enhance cognitive abilities, while secondary goals include evaluating improvements in executive function and memory. Brain activity will also be monitored using electroencephalography (EEG) to understand the treatment's effects on neural circuits.

Why it matters

Who can join: the full rules

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

Where it's running

• Rotman Research Institute at Baycrest
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Linda Mah — Baycrest Rotman Research Institute
• Study coordinator: Amanda Rahmadian
• Email: dtms@research.baycrest.org
• Phone: 416-785-2500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.