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

Not Applicable

Recruiting

• Conditions: Alzheimer Disease
• Interventions: Device: active tDCS

• Registration Number: NCT05478681
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-25
• Study First Submitted QC: 2022-07-25
• Study First Posted: 2022-07-28
• Study Start: 2023-04-17
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-26
• Primary Completion: 2024-08-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
active tDCS	active tDCS	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.

Primary Outcome Measures

Name	Time	Method
Acceptability of the tDCS treatment as assessed by the tDCS acceptability questionnaire	week 12	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
safety as assessed by the side effects questionnaire	week 6	side effects include itching, burning, headache, fatigue, and dizziness.

Secondary Outcome Measures

Name	Time	Method
Change in depressive symptoms as assessed by the Cornell Scale for Depression in Dementia (CSDD)	Baseline, Week 6 and Week 12.	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
Change in dementia-related behavioral symptoms as assessed by the Neuropsychiatric Inventory (NPI-Q) scale	Baseline, week 2, week 4, week 6, 6 weeks post treatment	NPI-Q evaluates 12 discrete neuropsychiatric symptoms considering their severity and the related caregiver distress.
Change in cognition as evaluated by the Mini-Mental State Examination (MMSE)	Baseline, Week 6 and Week 12.	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.
Change in apathy as assessed by the Brief Dimensional Apathy Scale (b-DAS)	Baseline, Week 6 and Week 12.	This scale consists of 9 questions each one scored from 0(almost always) to 3(hardly ever), higher scores indicate more apathy

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States