An interventional study of Brain Stimulation in Alzheimer&Amp;#39;s Disease-related Dementia, Alzheimer Disease and rTMS Stimulation, sponsored by Baylor College of Medicine. Not yet recruiting at 1 site in United States. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Treatment
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:
Participants will:
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.
This study is designed to explore a new way to manage behavioral and emotional symptoms in people with Alzheimer's Disease (AD) and related dementias (ADRD). Many people with these conditions experience mood swings, apathy, or agitation, which can be difficult to treat with current medications due to limited effectiveness and side effects. This research is testing whether two types of brain stimulation, called iTBS (intermittent theta burst stimulation) and tDCS (transcranial direct current stimulation), can be combined to provide a non-invasive and potentially effective treatment for these symptoms.
Brain stimulation is already used in other areas of medicine and involves applying gentle magnetic or electrical stimulation to the brain. iTBS uses short bursts of magnetic pulses, while tDCS uses a low electrical current. Both methods are painless, safe, and do not require surgery. This study is the first to look at combining these two techniques for people with AD/ADRD, based on findings from other research that suggest the combination might have stronger effects than either method alone.
Since this is a pilot study, the focus is on understanding whether the treatment process is practical for both patients and caregivers. This includes evaluating how easy it is for participants to attend the clinic sessions, whether caregivers can successfully administer the at-home treatments, and whether the overall process is manageable for families. In addition to these practical questions, researchers will also collect preliminary data to see if the treatment helps improve behavioral symptoms and measure any changes in the brain using scans and brain activity tests.
Participants will spend one week receiving treatments in a clinic and four weeks using a portable device for at-home sessions. Researchers will closely monitor participants throughout the study to ensure safety and will follow up to see if any improvements last after the treatment ends.
The study is an important step in understanding whether this new approach has potential to help people with AD/ADRD and whether it should be studied further in larger trials. It also aims to identify how to make the treatment process as smooth and effective as possible for patients and caregivers.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 20 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
6) 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.
Participants will receive a combination of two non-invasive brain stimulation treatments. During the first week, iTBS sessions will be administered in-clinic for five consecutive days, using magnetic pulses to target brain areas associated with neuropsychiatric symptoms. This is followed by four weeks of daily, self-administered tDCS at home, delivering a low electrical current to modulate brain activity. Participants will complete brain scans and questionnaires at various points to evaluate changes in the brain and symptom severity.
Device: Brain 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
Feasibility of iTBS-tDCS treatment in ADRD patients
The feasibility of providing sequential iTBS-tDCS treatment to ADRD patients with neuropsychiatric symptoms is a primary focus. Feasibility will be assessed mainly through rates of by recruitment, retention and adherence. Recruitment rate is the number of enrolled patients divided by the total number of patients who initially approached the study or had interest in it. Retention rate is the percentage of patients who complete the entire study out of the initial enrolled participants, and then adherence rate is the number of completed iTBS and tDCS sessions divided by the total prescribed treatment sessions. Since feasibility is being evaluated as the primary aim instead of efficacy, there is no randomization or probability of group assignment. Each and every subject will undergo the same treatment stimulation process, as they will all have 1 week of in-clinic iTBS sessions and then four weeks of at-home tDCS sessions.
Time frame: From enrollment until the end of treatment at 5 weeks
Tolerability of iTBS-tDCS treatment in ADRD patients
The tolerability of providing sequential iTBS-tDCS treatment to ADRD patients with neuropsychiatric symptoms. Tolerability will be evaluated based on the frequency and severity of adverse events reported during the intervention period. These findings will inform the design and implementation of a larger clinical trial.
Time frame: From enrollment until the end of treatment at 5 weeks
Neuropsychiatric Symptoms
We will gather preliminary data on the potential effects of iTBS-tDCS on neuropsychiatric symptoms in individuals with Alzheimer's Disease and related dementias, as determined by changes in standardized neuropsychiatric symptom questionnaires pre- and post-treatment.
Time frame: From enrollment until the end of treatment at 5 weeks
Caregiver burden
We will also explore the potential impact of the treatment on caregiver burden using caregiver-reported outcomes collected before and after the intervention. The total score of caregiver burden will involve the sum of the responses to all items on the Zarit Burden Interview assessment, and these scores are rated on a Likert scale of 0-4. This total score quantifies the level of caregiver burden, as high scores will indicate greater burden. Descriptive statistics; such as mean, median, and standard deviation-will summarize the overall caregiver burden within the study sample. Other factors associated with determining caregiver burden include inferential statistical methods like multiple regression analysis or ANOVA, as these will be used to examine connections between ZBI scores and variables such as patient cognitive function, treatment compliance, and demographic factors.
Time frame: At baseline (week 0) and post-treatment (week 6)
Brain connectivity through MRI
We can observe potential changes in brain connectivity through functional MRI scans conducted pre- and post-treatment, to inform hypotheses for future studies. The MRI will be used to obtain baseline images and neuromodulation-induced changes of brain structure as well as functional connectivity, particularly in the default mode and salience networks.
Time frame: At baseline visit (week 0) and post-treatment (week 6)
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