Using deep brain stimulation and cognitive training to improve memory in older adults with cognitive decline
Effect of Deep Transcranial Magnetic Stimulation (dTMS) on Cognition in Older Adults With Subjective Cognitive Decline (SCD)
NA · Rotman Research Institute at Baycrest · NCT06095063
This study is testing whether a combination of brain stimulation and memory training can help older adults with early signs of memory problems improve their thinking skills.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 55 Years to 70 Years |
| Sex | All |
| Sponsor | Rotman Research Institute at Baycrest (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06095063 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 55 to 70 with subjective cognitive decline and a family history of Alzheimer's disease.
Not a fit: Patients without a family history of Alzheimer's disease or those with significant neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to new interventions that improve cognitive function and delay the onset of Alzheimer's disease in at-risk older adults.
How similar studies have performed: While the combination of dTMS and cognitive training is a novel approach, previous studies have shown promise in using dTMS for cognitive enhancement.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alzheimer Disease, Subjective Cognitive Decline