Effect of Accelerated Neuromodulation of Anterior Cingulate Cortex to Enhance Cognition in Older Adults With Mild Memory Problems (NACC-EC)

Rotman Research Institute at Baycrest

Status

Enrolling

Conditions

Mild Cognitive Impairment (MCI)

Subjective Cognitive Decline (SCD)

Treatments

Device: Active Brainsway H7-Coil Deep TMS System

Device: Sham Brainsway H1-Coil Deep TMS System

Study type

Interventional

Funder types

Other

Identifiers

NCT07212504

25-04

Details and patient eligibility

About

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 adults with Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI). The study will look at whether it is safe and tolerable to use accelerated dTMS to enhance the benefits of cognitive training in older adults, and will also gather early information on the effects of accelerated dTMS on memory and other cognitive abilities.

Full 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 target the anterior cingulate cortex (ACC) in older adults aged 55-85 with MCI or SCD. Thirty older adults will participate in a single site, double-blind, randomized sham-controlled trial using an accelerated schedule of multiple dTMS sessions per day for 2-5 consecutive days, followed by 6 weeks of online cognitive remediation for both sham and dTMS interventions. The primary goal of the study is to establish the feasibility of an a-iTBS protocol combined with cognitive training in older adults with Mild Cognitive Impairment (MCI) and Subjective Cognitive Decline (SCD) and to obtain preliminary evidence of treatment efficacy.

Enrollment

30 estimated patients

Sex

All

Ages

55 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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