Actively Recruiting
Brain Stimulation and Cognitive Training for MCI
Led by Medical University of South Carolina · Updated on 2026-04-13
50
Participants Needed
1
Research Sites
219 weeks
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
This is a randomized clinical trial of a treatment that combines non-invasive brain stimulation with computerized cognitive training (CCT) for people with mild cognitive impairment (MCI). The form of brain stimulation used in this study is accelerated intermittent theta burst stimulation (iTBS). All participants receive the same amount of iTBS and are randomly assigned to engage in one of two types of CCT. The goals of the study are to see if this combined treatment is feasible and acceptable to people with MCI and whether combined iTBS and CCT improves memory, thinking skills, mood, and daily function.
CONDITIONS
Official Title
Brain Stimulation and Cognitive Training for MCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 60 and 85 years, inclusive
- English as first or primary language
- Adequate sensorimotor function and verbal abilities to complete assessments
- Having a co-participant with at least weekly in-person contact willing to participate as collateral informant
- Stable dose of medications (e.g., cholinesterase inhibitors, NMDA receptor antagonists, antidepressants) for at least 4 weeks before enrollment
- Prior anti-amyloid monoclonal antibody therapy allowed if last infusion was at least 8 weeks prior; current treatment allowed if dose stable for at least 12 weeks with no planned changes
- Prior TMS treatment allowed if last session was at least 24 weeks before enrollment
- Documented diagnosis of mild cognitive impairment (MCI) or mild neurocognitive disorder within the past year with presumed Alzheimer's disease etiology
- Met neuropsychological criteria for MCI within the past year
You will not qualify if you...
- Telephone Interview for Cognitive Status (TICS) score of 22 or less indicating possible dementia
- Prior diagnosis of dementia or major neurocognitive disorder
- Daily or weekly use of anticholinergic or sedative medications (stimulants may be allowed pending review)
- History of significant or unstable medical or mental health conditions that may affect cognition (e.g., heart failure, HIV, severe mental illness, brain cancer, substance use disorder, neurological diseases)
- Plans to start monoclonal antibody therapy for Alzheimer's or MCI during study
- History of significant amyloid-related imaging abnormalities if currently receiving monoclonal antibody therapy
- Current use of implanted brain stimulation devices
- Participation in another clinical trial or use of investigational medication/device affecting cognition or mood within last 30 days
- Contraindications to MRI or TMS (e.g., ferromagnetic implants, seizure risk conditions)
- Unable or unwilling to participate in BrainHQ activities
- No identifiable motor threshold for TMS
AI-Screening
AI-Powered Screening
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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
CONTACT
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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