Novel Brain Stimulation Treatment for Neuropsychiatric Symptoms in Alzheimer's Disease
Recruiting · NCT06835283 · Interventional (participants receive a specific treatment) · Lead sponsor: Baylor College of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- veteran between the ages of 60 to 85
- clinical diagnosis of mild to moderate Alzheimer's disease or related dementia
- clinically significant neuropsychiatric symptoms (NPS) evidenced by a score ≥ 2 in at least one domain of the Neuropsychiatric Inventory Questionnaire
- mild to moderate cognitive impairment demonstrated by a Mini-Mental State Examination (MMSE) score of 15-23
- have a caregiver who is able and willing to escort the patient to/from clinic visits, answer questionnaires, and assist in the implementation of treatment sessions at home
- if taking psychotropic medications, demonstrate stability for at least 4 weeks of treatment
Exclusion criteria
- any contraindication for MRI
- any contraindication for iTBS/tDCS including but not limited to seizure disorder, severe cardiovascular disease, history of brain surgery, or stroke involving the cerebral cortex near area of stimulation
- current alcohol or substance use disorder determined by QuickSCID (nicotine allowed; mild cannabis and alcohol use is allowed)
- neuropsychiatric symptoms (NPS) that are severe enough to preclude the intervention from being delivered safely and effectively, particularly agitation or aggression.
- \) any unstable coexisting medical condition that in the opinion of the principal investigator(s) interferes with the treatment protocol or increase the likelihood of adverse events.
Where it is running
1 location listed across 1 US state.
- Michael E. DeBakey VA Medical Center - Houston, Texas, United States