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Completed

NCT Number: NCT05478681

Home-based Transcranial Direct Current Stimulation (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.

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Key information

Conditions

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

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire

    Time frame: week 2

    The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment.

  2. Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire

    Time frame: week 4

    The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment.

  3. Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire

    Time frame: week 6

    The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment.

  4. Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire

    Time frame: week 12

    The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment.

  5. Safety as Assessed by the Side Effects Questionnaire

    Time frame: week 2

    side effects include itching, burning, headache, fatigue, and dizziness.

  6. Safety as Assessed by the Side Effects Questionnaire

    Time frame: week 4

    side effects include itching, burning, headache, fatigue, and dizziness.

  7. Safety as Assessed by the Side Effects Questionnaire

    Time frame: week 6

    side effects include itching, burning, headache, fatigue, and dizziness.

Secondary outcomes

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

    Time frame: Baseline, week 2, week 4, week 6, week 12

    NPI-Q evaluates 12 discrete neuropsychiatric symptoms considering their severity and the related caregiver distress.

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Texas Alzheimer's Research and Care Consortium

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 28, 2022
Registry last updated
Oct 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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