Actively Recruiting
Combining Brain Stimulation With Computerized Cognitive Training for Mild Cognitive Impairment
Led by Medical University of South Carolina · Updated on 2026-05-22
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Medical University of South Carolina
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a combined treatment of non-invasive brain stimulation and computerized cognitive training (CCT) for people with mild cognitive impairment (MCI). This randomized, sham-controlled trial aims to determine the feasibility, acceptability, and preliminary effects of a 3-day combined treatment on memory, thinking skills, mood, and daily function in individuals aged 60 to 85. The study is led by the Medical University of South Carolina and focuses on improving neurocognitive and psychosocial function in MCI. Participants receive accelerated intermittent theta burst stimulation (iTBS) using a MagVenture MagPro Transcranial Magnetic Stimulation system with neuronavigation. They will undergo 12 sessions of iTBS (3 minutes each) per treatment day, across 3 treatment days within an 8-day period. During 15-minute breaks between iTBS sessions, participants engage in 11 sessions of computerized cognitive training daily. They are randomly assigned to either active adaptive training or sham non-adaptive control games delivered online through the BrainHQ platform. Throughout the study, participants will be assessed at multiple time points including before treatment, one week after treatment, and four weeks post-treatment. Researchers will measure retention, adherence, acceptability, and changes in cognitive performance using tools such as the NIH Toolbox-Cognition Battery and the Preclinical Alzheimer's Cognitive Composite. Additional evaluations include dementia rating scales and informant-rated cognition. The total study period extends to 6 weeks post-enrollment, allowing monitoring of effects and safety.
CONDITIONS
Brief Title
Brain Stimulation and Cognitive Training for MCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 to 85 years inclusive
- English as a first or primary language
- Adequate sensorimotor function and verbal ability to complete assessments
- Have a co-participant who has weekly in-person contact and is willing to participate
- On stable medication doses for 4 or more weeks before enrollment
- Prior anti-amyloid therapy allowed if last infusion was 8 or more weeks before enrollment
- Prior TMS treatment allowed if last session was 24 or more weeks before enrollment
- Documented diagnosis of mild cognitive impairment or mild neurocognitive disorder within the past year
- Meet neuropsychological criteria for mild cognitive impairment within the past year
You will not qualify if you...
- Telephone Interview for Cognitive Status score of 22 or less, suggestive of dementia
- Prior diagnosis of dementia or major neurocognitive disorder
- Daily or weekly use of anticholinergic or sedative medications
- History of significant or unstable conditions that may affect cognition, including certain cardiac, infectious, metabolic, cancer, mental illness, substance use, developmental, or neurological disorders
- Planning to start anti-amyloid monoclonal antibody therapy during the study
- History of significant amyloid-related imaging abnormalities
- Current use of any implanted brain stimulation device
- Participation in another clinical trial or use of investigational medication/device within 30 days
- MRI contraindications such as ferromagnetic implants or claustrophobia
- Unable or unwilling to engage in computerized cognitive training activities
- Contraindications to TMS or no identifiable motor threshold
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 to 8 days
Participants receive accelerated intermittent theta burst stimulation (iTBS) combined with computerized cognitive training (CCT) or sham CCT over 3 treatment days within an 8-day span.
3 treatment visits with multiple short sessions each day
Duration - Up to 5 weeks
Participants complete assessments to evaluate cognitive and psychosocial function after treatment ends.
Assessments at 1 week and 4 weeks post-treatment
Trial Site Locations
Total: 1 location
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
K
Kaitlin Cox
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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