Actively Recruiting
Transcranial Magnetic Stimulation for MCI
Led by Medical University of South Carolina · Updated on 2026-04-02
60
Participants Needed
1
Research Sites
201 weeks
Total Duration
On this page
Sponsors
M
Medical University of South Carolina
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this phase II study is to establish the dose-response curves of a safe and clinically feasible non-invasive brain stimulation technique (accelerated Transcranial Magnetic Stimulation (TMS)) to improve both depression and cognitive function in Mild Cognitive Impairment (MCI) patients with comorbid depression. It is known that TMS can effectively treat depression. Identifying the right dose of accelerated TMS in MCI patients is necessary prior to designing subsequent trials to determine efficacy. These results will inform future clinical trials of accelerated TMS for MCI, with the long-term goal of developing an efficacious treatment to prevent dementia.
CONDITIONS
Official Title
Transcranial Magnetic Stimulation 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 and verbal abilities to complete assessments
- Have a co-participant with at least weekly in-person contact willing to participate as a collateral informant
- On a stable medication regimen for at least 4 weeks prior to enrollment, including cholinesterase inhibitors, NMDA receptor antagonists, or antidepressants
- Prior anti-amyloid monoclonal antibody therapy allowed if last infusion was at least 8 weeks before enrollment
- Prior TMS treatment allowed if last session was at least 24 weeks before enrollment
- Documented diagnosis of Mild Cognitive Impairment per NIA-AA or Mild Neurocognitive Disorder per DSM-5 within the past 2 years, with possible or probable Alzheimer's disease or chronic cerebrovascular disease
- Meet neuropsychological criteria for MCI within the past 2 years with specified impaired scores
- History of any lifetime depression defined by current or past Major Depressive Disorder per DSM-5
You will not qualify if you...
- A TICS score of 19 or less indicating possible dementia
- Prior diagnosis of Dementia (NIA-AA) or Major Neurocognitive Disorder (DSM-5)
- Daily or weekly use of anticholinergic or sedative medications; stimulants may be allowed after review
- Significant or unstable medical conditions impacting cognition such as heart failure, infections, metabolic diseases, cancer affecting cognition, developmental disorders, or neurologic diseases
- Current or planned treatment with monoclonal antibody therapy for AD/MCI within three months of enrollment
- Current use of any implanted brain stimulation device
- Participation in another clinical trial or use of investigational medication/device within the last 30 days
- MRI contraindications such as ferromagnetic implants or claustrophobia
- TMS contraindications including ferromagnetic implants or conditions lowering seizure threshold
- Current alcohol or substance use disorder, bipolar disorder, schizophrenia spectrum or psychotic disorders, recent suicidal or homicidal intent, or suicide attempts within the past year
AI-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
A
Andreana Benitez, PhD
CONTACT
K
Katrina Madden, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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