RecruitingNot ApplicableNCT06835283

Novel Brain Stimulation Treatment for Neuropsychiatric Symptoms in Alzheimer's Disease

Sequential Accelerated ITBS / Remote tDCS for Treatment of Neuropsychiatric Symptoms in Alzheimer's Disease: A Pilot Study


Sponsor

Baylor College of Medicine

Enrollment

20 participants

Start Date

Aug 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 65 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new type of brain stimulation called intermittent theta burst stimulation (iTBS) combined with transcranial direct current stimulation (tDCS) — both are non-invasive and painless methods of activating brain regions — to reduce behavioral and psychological symptoms in veterans with Alzheimer's disease or related dementia. **You may be eligible if...** - You are a veteran between 60 and 85 years old - You have been diagnosed with mild to moderate Alzheimer's disease or a related dementia - You have noticeable behavioral or psychological symptoms (such as agitation, depression, or anxiety) - Your MMSE score is between 15 and 23 (indicating mild to moderate cognitive impairment) - You have a caregiver who can help you attend appointments and assist with at-home treatment sessions - Your psychiatric medications (if any) have been stable for at least 4 weeks **You may NOT be eligible if...** - You have a metal implant in your body incompatible with MRI or brain stimulation - You have a history of seizures - You have a pacemaker or similar implanted device Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBrain Stimulation

This intervention is distinct because it combines two non-invasive brain stimulation techniques, intermittent theta burst stimulation (iTBS) and transcranial direct current stimulation (tDCS), in a sequential manner. Unlike studies that evaluate these techniques individually, this study explores their combined and complementary effects, with iTBS priming the brain to enhance the subsequent impact of tDCS. The sequential design leverages different mechanisms of action: iTBS delivers magnetic pulses to targeted brain areas to modulate neural activity, while tDCS applies a low electrical current for sustained modulation. This approach specifically targets neuropsychiatric symptoms (e.g., mood swings, apathy, and agitation) in individuals with Alzheimer's Disease and related dementias (ADRD), a population often underserved by traditional interventions. The study also evaluates the feasibility of at-home tDCS administration, making it unique in combining clinical and caregiver-managed treat


Locations(1)

Michael E. DeBakey VA Medical Center

Houston, Texas, United States

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