Home-based tDCS for Apathy in Alzheimer's Disease

Alzheimer Disease and Related Dementias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04855643
• Other study ID #: HSC-MS-21-0089
• Status: Terminated
• Phase: N/A
• Start date: August 20, 2021
• Est. completion date: July 10, 2022

Study information

• Verified date: March 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: July 10, 2022
• Est. primary completion date: July 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer Disease and Related Dementias
• Dementia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Texas Alzheimer's Research and Care Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)