Back to resultsHome-based tDCS for Apathy in Alzheimer's Disease
Primary Purpose
Alzheimer Disease and Related Dementias
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
home-based active tDCS
home-based sham tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease and Related Dementias
Eligibility Criteria
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
Sites / Locations
- The University of Texas Health Science Center at HoustonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Treatment
Control Group
Arm Description
Outcomes
Primary Outcome Measures
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.
How satisfied the patient 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).
How satisfied the patient 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).
How satisfied the patient 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).
How satisfied the patient 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).
How satisfied the patient 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).
How safe home-based tDCS treatment is as measured by reporting side effects.
Safety will be assessed with a questionnaire about side effects that include itching, burning, headache, fatigue, and dizziness.
How safe home-based tDCS treatment is as measured by reporting side effects.
Safety will be assessed with a questionnaire about side effects that include itching, burning, headache, fatigue, and dizziness.
How safe home-based tDCS treatment is as measured by reporting side effects.
Safety will be assessed with a questionnaire about side effects that include itching, burning, headache, fatigue, and dizziness.
How safe home-based tDCS treatment is as measured by reporting side effects.
Safety will be assessed with a questionnaire about side effects that include itching, burning, headache, fatigue, and dizziness.
How safe home-based tDCS treatment is as measured by reporting side effects.
Safety will be assessed with a questionnaire about side effects that include itching, burning, headache, fatigue, and dizziness.
Secondary Outcome Measures
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)
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 depressive symptoms as assessed by the Cornell Scale for Depression in Dementia
This scale consists of 19 questions and each question is scored on a two-point scale: 0 = absent; 1 = mild or intermittent; 2 = severe; n / a = unable to evaluate
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.
Change in apathy as measured by the Apathy Evaluation Scale (AES)
18 items phrased as questions that are to be answered by the caregiver on a four-point Likert scale, with higher scores indicating greater severity of apathy.
Full Information
NCT ID
NCT04855643
First Posted
April 15, 2021
Last Updated
September 2, 2022
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Texas Alzheimer's Research and Care Consortium
1. Study Identification
Unique Protocol Identification Number
NCT04855643
Brief Title
Home-based tDCS for Apathy in Alzheimer's Disease
Official Title
Home-based Transcranial Direct Current Stimulation (tDCS) for Apathy in Alzheimer's Disease and Related Dementias (ADRD)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
January 31, 2023 (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 and Care Consortium
4. Oversight
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
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease and Related Dementias
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
home-based active tDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
home-based sham tDCS
Intervention Description
For sham stimulation, electric current will be applied only in the first 30s tDCS. All sessions will be remotely supervised by trained research staff.
Primary Outcome Measure Information:
Title
Number of participants included and who successfully completed the protocol.
Description
The feasibility will be assessed based on the recruitment rate (per month), randomization success, blind success, retention, and attrition rates.
Time Frame
through study completion, an average of 3 years
Title
How satisfied the patient was with the treatment as measured by the tDCS experience questionnaire.
Description
Acceptability will be measured using a Likert scale composed by 10 questions, each one ranging from 0 (strongly disagree) to 10 (strongly agree).
Time Frame
Baseline
Title
How satisfied the patient was with the treatment as measured by the tDCS experience questionnaire.
Description
Acceptability will be measured using a Likert scale composed by 10 questions, each one ranging from 0 (strongly disagree) to 10 (strongly agree).
Time Frame
2 weeks of treatment
Title
How satisfied the patient was with the treatment as measured by the tDCS experience questionnaire.
Description
Acceptability will be measured using a Likert scale composed by 10 questions, each one ranging from 0 (strongly disagree) to 10 (strongly agree).
Time Frame
4 weeks of treatment
Title
How satisfied the patient was with the treatment as measured by the tDCS experience questionnaire.
Description
Acceptability will be measured using a Likert scale composed by 10 questions, each one ranging from 0 (strongly disagree) to 10 (strongly agree).
Time Frame
6 weeks of treatment
Title
How satisfied the patient was with the treatment as measured by the tDCS experience questionnaire.
Description
Acceptability will be measured using a Likert scale composed by 10 questions, each one ranging from 0 (strongly disagree) to 10 (strongly agree).
Time Frame
6 weeks post-treatment
Title
How safe home-based tDCS treatment is as measured by reporting side effects.
Description
Safety will be assessed with a questionnaire about side effects that include itching, burning, headache, fatigue, and dizziness.
Time Frame
Baseline
Title
How safe home-based tDCS treatment is as measured by reporting side effects.
Description
Safety will be assessed with a questionnaire about side effects that include itching, burning, headache, fatigue, and dizziness.
Time Frame
2 weeks of treatment
Title
How safe home-based tDCS treatment is as measured by reporting side effects.
Description
Safety will be assessed with a questionnaire about side effects that include itching, burning, headache, fatigue, and dizziness.
Time Frame
4 weeks of treatment
Title
How safe home-based tDCS treatment is as measured by reporting side effects.
Description
Safety will be assessed with a questionnaire about side effects that include itching, burning, headache, fatigue, and dizziness.
Time Frame
6 weeks of treatment
Title
How safe home-based tDCS treatment is as measured by reporting side effects.
Description
Safety will be assessed with a questionnaire about side effects that include itching, burning, headache, fatigue, and dizziness.
Time Frame
6 weeks post-treatment
Secondary Outcome Measure Information:
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)
Time Frame
Baseline, treatment week 2, treatment week 4, treatment week 6, and 6 weeks post-treatment.
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, treatment week 2, treatment week 4, treatment week 6, and 6 weeks post-treatment.
Title
Change in depressive symptoms as assessed by the Cornell Scale for Depression in Dementia
Description
This scale consists of 19 questions and each question is scored on a two-point scale: 0 = absent; 1 = mild or intermittent; 2 = severe; n / a = unable to evaluate
Time Frame
Baseline, treatment week 6, and 6 weeks post-treatment.
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, treatment week 6, and 6 weeks post-treatment.
Title
Change in apathy as measured by the Apathy Evaluation Scale (AES)
Description
18 items phrased as questions that are to be answered by the caregiver on a four-point Likert scale, with higher scores indicating greater severity of apathy.
Time Frame
Baseline, treatment week 2, treatment week 4, treatment week 6, and 6 weeks post-treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio L Teixeira Jr, MD,PhD,MSc
Phone
(713) 486-2555
Email
Antonio.L.Teixeira@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lijin Jose, MD
Phone
(713) 486- 2622
Email
Lijin.Jose@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio L Teixeira Jr, MD.PhD,MSc
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio L Teixeira Jr, MD,PhD,MSc
Phone
713-486-2555
Email
Antonio.L.Teixeira@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Lijin Jose, MD
Phone
(713) 486- 2622
Email
Lijin.Jose@uth.tmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Home-based tDCS for Apathy in Alzheimer's Disease
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