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

NCT05478681 | Completed Results FDA Device

• 1 other identifier: HSC-MS-22-0296
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

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.

Conditions

Alzheimer Disease

Keywords

depression; anxiety; irritability; apathy; psychosis; tDCS

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (4)

• Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale

  Baseline, week 2, week 4, week 6, week 12

• Apathy as Assessed by the Brief Dimensional Apathy Scale (b-DAS)

  Baseline, Week 6 and Week 12.

• Depressive Symptoms as Assessed by the Cornell Scale for Depression in Dementia (CSDD)

  Baseline, Week 6 and Week 12.

• Cognition as Evaluated by the Mini-Mental State Examination (MMSE)

  Baseline, Week 6 and Week 12.

Study Arms (1)

active tDCS

EXPERIMENTAL

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

Interventions

active tDCS DEVICE

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.

active tDCS

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• any unstable concurrent medical conditions
• history of brain surgery
• seizure
• intracranial metal implantation
• current alcohol/substance use disorder

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Texas Alzheimer's Research and Care Consortium: collaborator

Study Sites (2)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Depression; Anxiety Disorders; Lethargy; Psychotic Disorders

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders

Results Point of Contact

• Title: Kendra M Anderson, PhD
• Organization: The University of Texas Health Science Center at Houston

Kendra.M.Anderson@uth.tmc.edu

713-486-0513

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 28, 2022
• Study Start: April 17, 2023
• Primary Completion: February 26, 2024
• Study Completion: February 26, 2024
• Last Updated: October 10, 2025
• Results First Posted: October 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)