Status:
RECRUITING
Effect of Accelerated Neuromodulation of Anterior Cingulate Cortex to Enhance Cognition in Older Adults With Mild Memory Problems
Lead Sponsor:
Rotman Research Institute at Baycrest
Conditions:
Mild Cognitive Impairment (MCI)
Subjective Cognitive Decline (SCD)
Eligibility:
All Genders
55-85 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to test whether an accelerated deep Transcranial Magnetic Stimulation (dTMS) protocol in combination with cognitive training can improve cognitive abilities in older...
Detailed Description
This study will examine the effects of combining cognitive remediation with accelerated intermittent theta burst stimulation (a-iTBS) using the H7 deep Transcranial Magnetic Stimulation (dTMS) coil to...
Eligibility Criteria
Inclusion
- 55 - 85 years of age (on the day of randomization)
- are male or post-menopausal female
- have a diagnosis of mild cognitive impairment (MCI) based on Montreal Cognitive Assessment score \< 26 or where available, results from clinical neuropsychological assessment, OR subjective memory concerns and first degree relative, living or deceased, with a probable or confirmed diagnosis of AD
- score 24 or higher on the Mini Mental State Examination (MMSE)
- 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
Exclusion
- have a metal plate in their head(such as an ear implant, implanted brain stimulators, aneurysm clips). Dental devices and implants that are non-magnetic are safe.
- 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 history of any psychotic disorder, bipolar disorder, eating disorder, obsessive compulsive disorder, post-traumatic stress disorder, or dementia
- 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 untreated hypo- or hyper-thyroidism
- have unstable medical condition(s)
- have any other known contraindications to TMS
- are on unstable doses of any psychotropic medication such as antidepressants, antipsychotic, mood stabilizers or memory enhancing medications
- regularly use benzodiazepines or other hypnotics within 2 weeks of randomization
Key Trial Info
Start Date :
November 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07212504
Start Date
November 15 2025
End Date
March 15 2027
Last Update
October 28 2025
Active Locations (1)
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1
Rotman Research Institute at Baycrest
Toronto, Ontario, Canada, M6A 2E1