Novel Brain Stimulation Treatment for Neuropsychiatric Symptoms in Alzheimer's Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-85
SponsorBaylor College of Medicine
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Brain Stimulation
DeviceThis 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
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Brain StimulationOther 1 intervention
Trial outcomes
Primary outcomes
1
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 weeks2
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 weeksSecondary outcomes
1
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 weeks2
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)3
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: