Home-based Transcranial Direct Current Stimulation (tDCS) for Behavioral Symptoms in Alzheimer's Disease and Related Dementias (ADRD)

Study Overview
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Brief Summary
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The purpose of this study is to assess acceptability, and safety of providing tDCS to ADRD patients with behavioral symptoms and to assess the efficacy of tDCS for ADRD-related symptoms, mainly behavioral symptoms.

Official Title
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Home-based tDCS for Behavioral Symptoms in Alzheimer's Disease and Related Dementias (ADRD)

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Device: active tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: have ADRD and clinically-meaningful behavioral symptoms have a caregiver willing to participate in the study can speak and read English have stable doses of medications for at least one month Exclusion Criteria: any unstable concurrent medical conditions history of brain surgery seizure intracranial metal implantation current alcohol/substance use disorder

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active tDCS<br>All participants will receive active tDCS with a constant current intensity of 2mA. Anodal tDCS will be applied to the left dorsolateral prefrontal cortex, while cathodal electrode will be positioned on the right dorsolateral prefrontal cortex. Caregivers will help setting up and administering tDCS for participants with AD at home. tDCS will be applied for 30min at an intensity of 2mA, with 30 s ramping up and down. | Device: active tDCS<br>* All participants will receive active tDCS with a constant current intensity of 2mA. Anodal tDCS will be applied to the left dorsolateral prefrontal cortex, while cathodal electrode will be positioned on the right dorsolateral prefrontal cortex. Caregivers will help setting up and administering tDCS for participants with AD at home. tDCS will be applied for 30min at an intensity of 2mA, with 30 s ramping up and down.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of the tDCS treatment as assessed by the tDCS acceptability questionnaire | This scale will ask 10 questions and each question will be rated form 0(strongly agree) to 10(strongly disagree) for a total score of 100, a higher number indicating higher acceptance of the tDCS treatment | week 2 | 
| Acceptability of the tDCS treatment as assessed by the tDCS acceptability questionnaire | This scale will ask 10 questions and each question will be rated form 0(strongly agree) to 10(strongly disagree) for a total score of 100, a higher number indicating higher acceptance of the tDCS treatment | week 4 | 
| Acceptability of the tDCS treatment as assessed by the tDCS acceptability questionnaire | This scale will ask 10 questions and each question will be rated form 0(strongly agree) to 10(strongly disagree) for a total score of 100, a higher number indicating higher acceptance of the tDCS treatment | week 6 | 
| Acceptability of the tDCS treatment as assessed by the tDCS acceptability questionnaire | This scale will ask 10 questions and each question will be rated form 0(strongly agree) to 10(strongly disagree) for a total score of 100, a higher number indicating higher acceptance of the tDCS treatment | week 12 | 
| safety as assessed by the side effects questionnaire | side effects include itching, burning, headache, fatigue, and dizziness. | week 2 | 
| safety as assessed by the side effects questionnaire | side effects include itching, burning, headache, fatigue, and dizziness. | week 4 | 
| safety as assessed by the side effects questionnaire | side effects include itching, burning, headache, fatigue, and dizziness. | week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dementia-related behavioral symptoms as assessed by the Neuropsychiatric Inventory (NPI-Q) scale | NPI-Q evaluates 12 discrete neuropsychiatric symptoms considering their severity and the related caregiver distress. | Baseline, week 2, week 4, week 6, 6 weeks post treatment | 
| Change in apathy as assessed by the Brief Dimensional Apathy Scale (b-DAS) | This scale consists of 9 questions each one scored from 0(almost always) to 3(hardly ever), higher scores indicate more apathy | Baseline, Week 6 and Week 12. | 
| Change in depressive symptoms as assessed by the Cornell Scale for Depression in Dementia (CSDD) | This questionnaire has 19 questions and each is scored from 0(absent) to 2(severe). A total score greater than 10 indicates probable major depressive episode and a score of greater than 18 indicates definite major depressive episode | Baseline, Week 6 and Week 12. | 
| Change in cognition as evaluated by the Mini-Mental State Examination (MMSE) | Mini-Mental State Examination (MMSE) includes memory, language, praxis and orientation tasks, yielding a global cognition score ranging 0 to 30, with higher scores indicating better performance. | Baseline, Week 6 and Week 12. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, anxiety, irritability, apathy, psychosis, tDCS