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

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

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Device: active tDCS

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
    • San Antonio, Texas, United States, 78229
      • The University of Texas Health Science Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire	The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment.	week 2
Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire	The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment.	week 4
Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire	The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment.	week 6
Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire	The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates 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
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, week 12
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.
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.
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.

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Texas Alzheimer's Research and Care Consortium
• Investigators: Principal Investigator: Kendra M Anderson, PhD, The University of Texas Health Science Center, Houston; Principal Investigator: Antonio L Teixeira, MD, The University of Texas Health Science Center at San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Actual): February 26, 2024
• Study Completion (Actual): February 26, 2024

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Estimated): October 10, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: tDCS; depression; irritability; psychosis; anxiety; apathy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavioral Symptoms; Neurobehavioral Manifestations; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Psychotic Disorders; Anxiety Disorders; Alzheimer Disease; Depression; Lethargy
• Other Study ID Numbers: HSC-MS-22-0296

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No