Actively Recruiting
Novel Brain Stimulation Treatment for Neuropsychiatric Symptoms in Alzheimer's Disease
Led by Baylor College of Medicine · Updated on 2026-05-07
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this pilot study is to test a combination of two non-invasive brain stimulation methods, called iTBS (intermittent theta burst stimulation) and tDCS (transcranial direct current stimulation), in people with Alzheimer's Disease (AD) and related dementias (ADRD). This study will also explore whether the combined treatment shows promise for reducing neuropsychiatric symptoms like mood swings, apathy, and agitation, and will evaluate the impact of the treatment on caregivers. The main questions the study aims to answer are: 1. Is the combined brain stimulation treatment practical and well-tolerated? 2. Do preliminary results suggest that this treatment could help manage neuropsychiatric symptoms and support a larger study? Participants will: * Attend nine in-person visits over three months. * Complete one week of in-clinic brain stimulation sessions (iTBS) followed by four weeks of daily at-home brain stimulation sessions (tDCS). * Take part in brain scans, questionnaires, and brain activity tests before and after the treatment. This pilot study is a first step to assess whether this combined treatment approach is practical and whether it has potential to improve symptoms, laying the groundwork for larger studies in the future.
CONDITIONS
Official Title
Novel Brain Stimulation Treatment for Neuropsychiatric Symptoms in Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Veteran aged 60 to 85 years
- Clinical diagnosis of mild to moderate Alzheimer's disease or related dementia
- Clinically significant neuropsychiatric symptoms with a score of 2 or higher in at least one domain of the Neuropsychiatric Inventory Questionnaire
- Mild to moderate cognitive impairment with a Mini-Mental State Examination (MMSE) score between 15 and 23
- Have a caregiver willing and able to escort to clinic visits, answer questionnaires, and assist with at-home treatment
- Stable psychotropic medication use for at least 4 weeks if applicable
You will not qualify if you...
- Any contraindication for MRI
- Any contraindication for iTBS/tDCS including seizure disorder, severe cardiovascular disease, history of brain surgery, or stroke near stimulation area
- Current alcohol or substance use disorder (nicotine allowed; mild cannabis and alcohol use allowed)
- Neuropsychiatric symptoms severe enough to prevent safe and effective treatment, especially severe agitation or aggression
- Any unstable medical condition that interferes with treatment or increases risk of adverse events
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
L
Lane Witkowski Research Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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