Actively Recruiting
Effect of Accelerated Neuromodulation of Anterior Cingulate Cortex to Enhance Cognition in Older Adults With Mild Memory Problems
Led by Rotman Research Institute at Baycrest · Updated on 2025-10-28
30
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating whether an accelerated deep Transcranial Magnetic Stimulation (dTMS) combined with cognitive training can improve cognitive abilities in older adults aged 55 to 85 who have Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI). This study aims to determine the safety and tolerability of this accelerated dTMS protocol and gather early information about its effects on memory and other cognitive functions. It is a double-blind, randomized, sham-controlled trial conducted at a single site by the Rotman Research Institute at Baycrest. Participants will be randomly assigned to receive either active dTMS using the Brainsway H7-Coil or a sham stimulation using the H1-Coil helmet. The dTMS is administered 6 to 8 times daily for 2 to 5 consecutive days, followed by 6 weeks of online cognitive remediation for all participants. This accelerated intermittent theta burst stimulation (a-iTBS) targets the anterior cingulate cortex (ACC) to explore its potential to enhance cognitive training effects. During the study, participants will be closely monitored for attendance, adverse events, and reasons for withdrawal. Cognitive abilities, including memory and executive function, will be assessed with computerized neuropsychological tests before and after treatment. Additional evaluations include anxiety and depression scales, brain activity through EEG and MEG, and MRI scans to measure brain connectivity. The entire participation lasts at least 9 weeks, with safety and cognitive changes tracked throughout the study period.
CONDITIONS
Brief Title
Effect of Accelerated Neuromodulation of Anterior Cingulate Cortex to Enhance Cognition in Older Adults With Mild Memory Problems
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 55 and 85 years on the day of randomization
- Male or post-menopausal female
- Diagnosis of mild cognitive impairment based on Montreal Cognitive Assessment score below 26 or clinical neuropsychological assessment, OR subjective memory concerns with a first-degree relative diagnosed with Alzheimer's disease
- Mini Mental State Examination score of 24 or higher
- Willing to provide informed consent
- Able to follow the treatment schedule
- Stable on medications for at least 2 months with no expected changes during the study
- Satisfactory safety screening questionnaire for Transcranial Magnetic Stimulation (TMS)
You will not qualify if you...
- Presence of metal plates in the head, such as ear implants or implanted brain stimulators
- Known or history of increased brain pressure that raises seizure risk
- Cardiac pacemaker
- Implanted medication pump
- Central venous line
- History of psychotic disorders, bipolar disorder, eating disorders, obsessive compulsive disorder, post-traumatic stress disorder, or dementia
- Substance abuse within the last 6 months
- History of stroke or brain lesions
- Personal or family history of epilepsy
- Pregnant or breastfeeding women
- History of abnormal brain MRI
- Untreated thyroid disorders
- Unstable medical conditions
- Any other contraindications to TMS
- Unstable doses of psychotropic medications such as antidepressants, antipsychotics, mood stabilizers, or memory-enhancing drugs
- Regular benzodiazepine or hypnotic use within 2 weeks before randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 5 days
Participants receive accelerated intermittent theta burst stimulation (a-iTBS) or sham stimulation using the Brainsway H7 or H1 deep TMS coil 6 to 8 times a day for 2 to 5 consecutive days.
Multiple visits per day for up to 5 days
Duration - 6 weeks
Participants engage in 6 weeks of online cognitive remediation following the stimulation sessions.
Online activities with flexible scheduling
Trial Site Locations
Total: 1 location
1
Rotman Research Institute at Baycrest
Toronto, Ontario, Canada, M6A 2E1
Actively Recruiting
Research Team
A
Amanda Chao, MPH
L
Linda Mah, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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