Home-based tDCS for Apathy in Alzheimer's Disease
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment
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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.
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| Sham Comparator: Control Group
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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.
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Outcome Measures
Primary Outcome Measures
- Number of participants included and who successfully completed the protocol. [through study completion, an average of 3 years]
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. [Baseline]
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. [2 weeks of treatment]
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. [4 weeks of treatment]
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. [6 weeks of treatment]
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. [6 weeks post-treatment]
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. [Baseline]
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. [2 weeks of treatment]
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. [4 weeks of treatment]
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. [6 weeks of treatment]
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. [6 weeks post-treatment]
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) [Baseline, treatment week 2, treatment week 4, treatment week 6, and 6 weeks post-treatment.]
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 [Baseline, treatment week 2, treatment week 4, treatment week 6, and 6 weeks post-treatment.]
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 [Baseline, treatment week 6, and 6 weeks post-treatment.]
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) [Baseline, treatment week 6, and 6 weeks post-treatment.]
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) [Baseline, treatment week 2, treatment week 4, treatment week 6, and 6 weeks post-treatment.]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of possible or probable ADRD according to the National Institute of Aging - Alzheimer's Association diagnostic criteria
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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).
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Stable doses of cholinesterase inhibitors, memantine and other psychotropic medications for at least three months.
Exclusion Criteria:
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Unstable medical conditions
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History of epilepsy
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Metallic objects in the brain
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Diagnosis of major depression and/or a score higher than 18 on the Cornell Scale for Depression in Dementia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Texas Health Science Center at Houston | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- The University of Texas Health Science Center, Houston
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSC-MS-21-0089