Home-based tDCS for Apathy in Alzheimer's Disease

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

The purpose of this study is to assess feasibility, acceptability, and safety of providing tDCS to Alzheimer's disease and related dementias (ADRD) patients with apathy and to assess the efficacy of tDCS for ADRD-related symptoms, with a primary focus on apathy.

Study Overview

• Status: Terminated
• Conditions: Alzheimer Disease and Related Dementias
• Intervention / Treatment: Device: home-based active tDCS; Device: home-based sham tDCS

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

Contacts and Locations

• Study Contact: Name: Antonio L Teixeira Jr, MD,PhD,MSc; Phone Number: (713) 486-2555; Email: Antonio.L.Teixeira@uth.tmc.edu
• Study Contact Backup: Name: Lijin Jose, MD; Phone Number: (713) 486- 2622; Email: Lijin.Jose@uth.tmc.edu

Study Locations

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

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Diagnosis of possible or probable ADRD according to the National Institute of Aging - Alzheimer's Association diagnostic criteria
• Mild or moderate dementia, as defined by a MMSE score between 14 and 26
• Clinically meaningful apathy for at least four weeks, clinically diagnosed according to 2018 Apathy Diagnostic Criteria or defined as Neuropsychiatric Inventory (NPI-Q) apathy score equal or above 4 (i.e., severity of 'moderate' or greater and caregiver distress 'mild' or greater).
• Stable doses of cholinesterase inhibitors, memantine and other psychotropic medications for at least three months.

Exclusion Criteria:

• Unstable medical conditions
• History of epilepsy
• Metallic objects in the brain
• Diagnosis of major depression and/or a score higher than 18 on the Cornell Scale for Depression in Dementia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment	Device: home-based active tDCS; Anode and cathode electrodes will be placed over the left and right dorsolateral prefrontal cortexes, respectively, with the use of the Omni-Lateral-Electrode system. Caregivers will set up and administer tDCS for participants with ADRD at home. tDCS will be applied for 30 min at an intensity of 2mA, with 30 s ramping up and down. All sessions will be remotely supervised by trained research staff.
Sham Comparator: Control Group	Device: home-based sham tDCS; For sham stimulation, electric current will be applied only in the first 30s tDCS. All sessions will be remotely supervised by trained research staff.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Included and Who Successfully Completed the Protocol	The feasibility will be assessed based on the recruitment rate (per month), randomization success, blind success, retention, and attrition rates.	through study completion (about 12 weeks)
How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire	Acceptability will be measured using a Likert scale composed by 10 questions, each one ranging from 0 (strongly disagree) to 10 (strongly agree). The 10 prompts are as followed: It was easy to prepare the device and accessories; The device was unnecessarily complex; The device was easy to use; I felt the video conferences with a technical person were helpful; I would imagine that most people would learn to use this device quickly; The device was cumbersome to use; I felt confident using the device; I needed to learn a lot of things before I could get going with this device; The effectiveness of the treatment increased over the course of treatment; Overall, I felt that transcranial electrical stimulation treatment benefited me	Baseline
How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire	Acceptability will be measured using a Likert scale composed by 10 questions, each one ranging from 0 (strongly disagree) to 10 (strongly agree). The 10 prompts are as followed: It was easy to prepare the device and accessories; The device was unnecessarily complex; The device was easy to use; I felt the video conferences with a technical person were helpful; I would imagine that most people would learn to use this device quickly; The device was cumbersome to use; I felt confident using the device; I needed to learn a lot of things before I could get going with this device; The effectiveness of the treatment increased over the course of treatment; Overall, I felt that transcranial electrical stimulation treatment benefited me	2 weeks of treatment
How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire	Acceptability will be measured using a Likert scale composed by 10 questions, each one ranging from 0 (strongly disagree) to 10 (strongly agree). The 10 prompts are as followed: It was easy to prepare the device and accessories; The device was unnecessarily complex; The device was easy to use; I felt the video conferences with a technical person were helpful; I would imagine that most people would learn to use this device quickly; The device was cumbersome to use; I felt confident using the device; I needed to learn a lot of things before I could get going with this device; The effectiveness of the treatment increased over the course of treatment; Overall, I felt that transcranial electrical stimulation treatment benefited me	4 weeks of treatment
How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire	Acceptability will be measured using a Likert scale composed by 10 questions, each one ranging from 0 (strongly disagree) to 10 (strongly agree). The 10 prompts are as followed: It was easy to prepare the device and accessories; The device was unnecessarily complex; The device was easy to use; I felt the video conferences with a technical person were helpful; I would imagine that most people would learn to use this device quickly; The device was cumbersome to use; I felt confident using the device; I needed to learn a lot of things before I could get going with this device; The effectiveness of the treatment increased over the course of treatment; Overall, I felt that transcranial electrical stimulation treatment benefited me	6 weeks of treatment
How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire	Acceptability will be measured using a Likert scale composed by 10 questions, each one ranging from 0 (strongly disagree) to 10 (strongly agree). The 10 prompts are as followed: It was easy to prepare the device and accessories; The device was unnecessarily complex; The device was easy to use; I felt the video conferences with a technical person were helpful; I would imagine that most people would learn to use this device quickly; The device was cumbersome to use; I felt confident using the device; I needed to learn a lot of things before I could get going with this device; The effectiveness of the treatment increased over the course of treatment; Overall, I felt that transcranial electrical stimulation treatment benefited me	6 weeks post-treatment (12 weeks from baseline)
Safety of Home-based tDCS Treatment as Assessed by Side Effects	Safety will be assessed with a questionnaire about side effects that include itching, burning, headache, fatigue, and dizziness.	From baseline to week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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). Total scores are reported by summing all of the item's scores, with a minimum of 0 and a maximum of 27. A high score indicates a worse outcome.	Baseline, treatment week 2 (2 weeks from baseline), treatment week 4 (4 weeks from baseline), treatment week 6 (6 weeks from baseline), and 6 weeks post-treatment (12 weeks from baseline)
Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Severity Score)	NPI-Q evaluates 12 discrete neuropsychiatric symptoms considering their severity and the related caregiver distress. The severity score ranges from 0 to 36. A high score indicates a worse outcome.	Baseline, treatment week 2 (2 weeks from baseline), treatment week 4 (4 weeks from baseline), treatment week 6 (6 weeks from baseline), and 6 weeks post-treatment (12 weeks from baseline)
Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Caregiver Distress Score)	NPI-Q evaluates 12 discrete neuropsychiatric symptoms considering their severity and the related caregiver distress.The caregiver distress score ranges from 0 to 60. A high score indicates a worse outcome.	Baseline, treatment week 2 (2 weeks from baseline), treatment week 4 (4 weeks from baseline), treatment week 6 (6 weeks from baseline), and 6 weeks post-treatment (12 weeks from baseline)
Depressive Symptoms as Assessed by the Cornell Scale for Depression in Dementia	This scale assess depressive symptoms and consists of 19 questions. Each question is scored on a 2-point severity scale: 0 = absent; 1 = mild or intermittent; 2 = severe. Total score range is 0 to 38, with a higher score indicating a worse outcome.	Baseline, treatment week 6 (6 weeks from baseline), and 6 weeks post-treatment (12 weeks from baseline)
Cognition as Evaluated by the Mini-Mental State Examination (MMSE)	The Mini-Mental State Examination (MMSE) includes memory, language, praxis and orientation tasks, yielding a global cognition score ranging from 0 to 30, with a higher score indicating better performance.	Baseline, treatment week 6 (6 weeks from baseline), and 6 weeks post-treatment(12 weeks from baseline)
Apathy as Measured by the Apathy Evaluation Scale (AES)	The Apathy Evaluation Scale (AES) consists of 18 items phrased as questions that are to be answered by the caregiver on a four-point Likert scale (1-4), with a higher score indicating greater severity of apathy. The score ranges from a minimum of 18 to a maximum of 72	Baseline, treatment week 2 (2 weeks from baseline), treatment week 4 (4 weeks from baseline), treatment week 6 (6 weeks from baseline), and 6 weeks post-treatment (12 weeks from baseline)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Texas Alzheimer's Research and Care Consortium
• Investigators: Principal Investigator: Antonio L Teixeira Jr, MD.PhD,MSc, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2021
• Primary Completion (Actual): July 10, 2022
• Study Completion (Actual): July 10, 2022

Study Registration Dates

• First Submitted: April 15, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Estimated): April 23, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: HSC-MS-21-0089

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