Alzheimer Disease
Conditions
Keywords
depression, anxiety, irritability, apathy, psychosis, tDCS
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.
Interventions
DEVICEactive tDCS
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.
Sponsors
Texas Alzheimer's Research and Care Consortium
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire | week 2 | The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment. |
| Safety as Assessed by the Side Effects Questionnaire | week 2 | side effects include itching, burning, headache, fatigue, and dizziness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale | Baseline, week 2, week 4, week 6, week 12 | NPI-Q evaluates 12 discrete neuropsychiatric symptoms considering their severity and the related caregiver distress. |
| Apathy as Assessed by the Brief Dimensional Apathy Scale (b-DAS) | 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 |
| Depressive Symptoms as Assessed by the Cornell Scale for Depression in Dementia (CSDD) | 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 |
| Cognition as Evaluated by the Mini-Mental State Examination (MMSE) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active tDCS 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.
active tDCS: 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. | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire
The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment.
Time frame: week 4
Population: Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Primary
Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire
The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment.
Time frame: week 2
Population: Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Primary
Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire
The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment.
Time frame: week 6
Population: Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Primary
Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire
The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment.
Time frame: week 12
Population: Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Primary
Safety as Assessed by the Side Effects Questionnaire
side effects include itching, burning, headache, fatigue, and dizziness.
Time frame: week 4
Population: Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Primary
Safety as Assessed by the Side Effects Questionnaire
side effects include itching, burning, headache, fatigue, and dizziness.
Time frame: week 2
Population: Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Primary
Safety as Assessed by the Side Effects Questionnaire
side effects include itching, burning, headache, fatigue, and dizziness.
Time frame: week 6
Population: Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
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), higher scores indicate more apathy
Time frame: Baseline, Week 6 and Week 12.
Population: Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Secondary
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.
Time frame: Baseline, Week 6 and Week 12.
Population: Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Secondary
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.
Time frame: Baseline, week 2, week 4, week 6, week 12
Population: Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Secondary
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
Time frame: Baseline, Week 6 and Week 12.
Population: Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.