Back to resultsHome-based Transcranial Direct Current Stimulation (tDCS) for Behavioral Symptoms in Alzheimer's Disease and Related Dementias (ADRD)
Primary Purpose
Alzheimer Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
active tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring depression, anxiety, irritability, apathy, psychosis, tDCS
Eligibility Criteria
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
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
active tDCS
Arm Description
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.
Outcomes
Primary Outcome Measures
Acceptability of the tDCS treatment as assessed by the tDCS acceptability questionnaire
This scale will ask 10 questions and each question will be rated form 0(strongly agree) to 10(strongly disagree) for a total score of 100, a higher number indicating higher acceptance of the tDCS treatment
Acceptability of the tDCS treatment as assessed by the tDCS acceptability questionnaire
This scale will ask 10 questions and each question will be rated form 0(strongly agree) to 10(strongly disagree) for a total score of 100, a higher number indicating higher acceptance of the tDCS treatment
Acceptability of the tDCS treatment as assessed by the tDCS acceptability questionnaire
This scale will ask 10 questions and each question will be rated form 0(strongly agree) to 10(strongly disagree) for a total score of 100, a higher number indicating higher acceptance of the tDCS treatment
Acceptability of the tDCS treatment as assessed by the tDCS acceptability questionnaire
This scale will ask 10 questions and each question will be rated form 0(strongly agree) to 10(strongly disagree) for a total score of 100, a higher number indicating higher acceptance of the tDCS treatment
safety as assessed by the side effects questionnaire
side effects include itching, burning, headache, fatigue, and dizziness.
safety as assessed by the side effects questionnaire
side effects include itching, burning, headache, fatigue, and dizziness.
safety as assessed by the side effects questionnaire
side effects include itching, burning, headache, fatigue, and dizziness.
Secondary Outcome Measures
Change in 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.
Change in 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
Change in 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
Change in 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.
Full Information
NCT ID
NCT05478681
First Posted
July 25, 2022
Last Updated
July 28, 2022
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Texas Alzheimer's Research & Care Consortium (TARCC)
1. Study Identification
Unique Protocol Identification Number
NCT05478681
Brief Title
Home-based Transcranial Direct Current Stimulation (tDCS) for Behavioral Symptoms in Alzheimer's Disease and Related Dementias (ADRD)
Official Title
Home-based tDCS for Behavioral Symptoms in Alzheimer's Disease and Related Dementias (ADRD)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Texas Alzheimer's Research & Care Consortium (TARCC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
depression, anxiety, irritability, apathy, psychosis, tDCS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
active tDCS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
active tDCS
Intervention Description
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 Outcome Measure Information:
Title
Acceptability of the tDCS treatment as assessed by the tDCS acceptability questionnaire
Description
This scale will ask 10 questions and each question will be rated form 0(strongly agree) to 10(strongly disagree) for a total score of 100, a higher number indicating higher acceptance of the tDCS treatment
Time Frame
week 2
Title
Acceptability of the tDCS treatment as assessed by the tDCS acceptability questionnaire
Description
This scale will ask 10 questions and each question will be rated form 0(strongly agree) to 10(strongly disagree) for a total score of 100, a higher number indicating higher acceptance of the tDCS treatment
Time Frame
week 4
Title
Acceptability of the tDCS treatment as assessed by the tDCS acceptability questionnaire
Description
This scale will ask 10 questions and each question will be rated form 0(strongly agree) to 10(strongly disagree) for a total score of 100, a higher number indicating higher acceptance of the tDCS treatment
Time Frame
week 6
Title
Acceptability of the tDCS treatment as assessed by the tDCS acceptability questionnaire
Description
This scale will ask 10 questions and each question will be rated form 0(strongly agree) to 10(strongly disagree) for a total score of 100, a higher number indicating higher acceptance of the tDCS treatment
Time Frame
week 12
Title
safety as assessed by the side effects questionnaire
Description
side effects include itching, burning, headache, fatigue, and dizziness.
Time Frame
week 2
Title
safety as assessed by the side effects questionnaire
Description
side effects include itching, burning, headache, fatigue, and dizziness.
Time Frame
week 4
Title
safety as assessed by the side effects questionnaire
Description
side effects include itching, burning, headache, fatigue, and dizziness.
Time Frame
week 6
Secondary Outcome Measure Information:
Title
Change in dementia-related behavioral symptoms as assessed by the Neuropsychiatric Inventory (NPI-Q) scale
Description
NPI-Q evaluates 12 discrete neuropsychiatric symptoms considering their severity and the related caregiver distress.
Time Frame
Baseline, week 2, week 4, week 6, 6 weeks post treatment
Title
Change in apathy as assessed by the Brief Dimensional Apathy Scale (b-DAS)
Description
This scale consists of 9 questions each one scored from 0(almost always) to 3(hardly ever), higher scores indicate more apathy
Time Frame
Baseline, Week 6 and Week 12.
Title
Change in depressive symptoms as assessed by the Cornell Scale for Depression in Dementia (CSDD)
Description
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
Time Frame
Baseline, Week 6 and Week 12.
Title
Change in cognition as evaluated by the Mini-Mental State Examination (MMSE)
Description
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.
Time Frame
Baseline, Week 6 and Week 12.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio L Teixeira, MD
Phone
713-486-2555
Email
Antonio.L.Teixeira@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lijin Jose
Phone
713-486-2700
Email
Lijin.Jose@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio L Teixeira, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio L Teixeira, MD
Phone
713-486-2555
Email
Antonio.L.Teixeira@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Lijin Jose
Phone
713-486-2700
Email
Lijin.Jose@uth.tmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Home-based Transcranial Direct Current Stimulation (tDCS) for Behavioral Symptoms in Alzheimer's Disease and Related Dementias (ADRD)
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