Alzheimer Disease and Related Dementias
Conditions
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.
Interventions
DEVICEhome-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.
DEVICEhome-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.
Sponsors
Texas Alzheimer's Research and Care Consortium
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Included and Who Successfully Completed the Protocol | through study completion (about 12 weeks) | The feasibility will be assessed based on the recruitment rate (per month), randomization success, blind success, retention, and attrition rates. |
| How Satisfied the Participant 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). The 10 prompts are as followed: 1. It was easy to prepare the device and accessories 2. The device was unnecessarily complex 3. The device was easy to use 4. I felt the video conferences with a technical person were helpful 5. I would imagine that most people would learn to use this device quickly 6. The device was cumbersome to use 7. I felt confident using the device 8. I needed to learn a lot of things before I could get going with this device 9. The effectiveness of the treatment increased over the course of treatment 10. Overall, I felt that transcranial electrical stimulation treatment benefited me |
| Safety of Home-based tDCS Treatment as Assessed by Side Effects | From baseline to week 12 | Safety will be assessed with a questionnaire about side effects that include itching, burning, headache, fatigue, and dizziness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms as Assessed by the Cornell Scale for Depression in Dementia | Baseline, treatment week 6 (6 weeks from baseline), and 6 weeks post-treatment (12 weeks from baseline) | 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. |
| Apathy as Assessed by the Brief Dimensional Apathy Scale (b-DAS) | 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) | 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. |
| Apathy as Measured by the Apathy Evaluation Scale (AES) | 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) | 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 |
| Cognition as Evaluated by the Mini-Mental State Examination (MMSE) | Baseline, treatment week 6 (6 weeks from baseline), and 6 weeks post-treatment(12 weeks from baseline) | 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. |
| Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Severity Score) | 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) | 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. |
| Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Caregiver Distress Score) | 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) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment 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. | 1 |
| Control Group 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. | 2 |
| Total | 3 |
Baseline characteristics
| Characteristic | Control Group | Total | Treatment |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 82 years STANDARD_DEVIATION 5 | 81 years STANDARD_DEVIATION 4.32 | 79 years STANDARD_DEVIATION 0 |
| Comorbidities Dyslipidemia | 2 Participants | 3 Participants | 1 Participants |
| Comorbidities Glaucoma | 1 Participants | 1 Participants | 0 Participants |
| Comorbidities Hypertension | 2 Participants | 3 Participants | 1 Participants |
| Comorbidities Osteoarthritis | 2 Participants | 3 Participants | 1 Participants |
| Medications in use Amlodipine | 1 Participants | 2 Participants | 1 Participants |
| Medications in use Aspirin | 1 Participants | 1 Participants | 0 Participants |
| Medications in use Atorvastatin | 1 Participants | 2 Participants | 1 Participants |
| Medications in use Carvedilol | 0 Participants | 1 Participants | 1 Participants |
| Medications in use Cilostasol | 0 Participants | 1 Participants | 1 Participants |
| Medications in use Citalopram | 1 Participants | 1 Participants | 0 Participants |
| Medications in use Clopidogrel | 0 Participants | 1 Participants | 1 Participants |
| Medications in use Donapezil | 1 Participants | 2 Participants | 1 Participants |
| Medications in use Duloxetine | 0 Participants | 1 Participants | 1 Participants |
| Medications in use Eliquis | 0 Participants | 1 Participants | 1 Participants |
| Medications in use Hydrochlorothiazide | 1 Participants | 1 Participants | 0 Participants |
| Medications in use Memantine | 1 Participants | 2 Participants | 1 Participants |
| Medications in use Pregabalin | 1 Participants | 1 Participants | 0 Participants |
| Medications in use Rosuvastatin | 1 Participants | 1 Participants | 0 Participants |
| Medications in use Sertraline | 1 Participants | 1 Participants | 0 Participants |
| Medications in use Tamsulosin | 1 Participants | 1 Participants | 0 Participants |
| Medications in use Vitamin B12 | 1 Participants | 1 Participants | 0 Participants |
| Medications in use Vitamin D | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 2 participants | 3 participants | 1 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
| Time Since Diagnosis | 3.5 years STANDARD_DEVIATION 1.5 | 3.33 years STANDARD_DEVIATION 1.5 | 3 years STANDARD_DEVIATION 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 2 |
| other Total, other adverse events | 1 / 1 | 2 / 2 |
| serious Total, serious adverse events | 0 / 1 | 0 / 2 |
Outcome results
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: 1. It was easy to prepare the device and accessories 2. The device was unnecessarily complex 3. The device was easy to use 4. I felt the video conferences with a technical person were helpful 5. I would imagine that most people would learn to use this device quickly 6. The device was cumbersome to use 7. I felt confident using the device 8. I needed to learn a lot of things before I could get going with this device 9. The effectiveness of the treatment increased over the course of treatment 10. Overall, I felt that transcranial electrical stimulation treatment benefited me
Time frame: Baseline
Population: Data were not collected for this outcome measure.
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: 1. It was easy to prepare the device and accessories 2. The device was unnecessarily complex 3. The device was easy to use 4. I felt the video conferences with a technical person were helpful 5. I would imagine that most people would learn to use this device quickly 6. The device was cumbersome to use 7. I felt confident using the device 8. I needed to learn a lot of things before I could get going with this device 9. The effectiveness of the treatment increased over the course of treatment 10. Overall, I felt that transcranial electrical stimulation treatment benefited me
Time frame: 2 weeks of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | It was easy to prepare the device and accessories | 2 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The device was unnecessarily complex | 2 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The device was easy to use | 2 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I felt the video conferences with a technical person were helpful | 8 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I would imagine that most people would learn to use this device quickly | 8 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The device was cumbersome to use | 1 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I felt confident using the device | 8 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I needed to learn a lot of things before I could get going with this device | 5 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The effectiveness of the treatment increased over the course of treatment | 2 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | Overall, I felt that transcranial electrical stimulation treatment benefited me | 1 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I needed to learn a lot of things before I could get going with this device | 0 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | It was easy to prepare the device and accessories | 10 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The device was cumbersome to use | 0 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The device was unnecessarily complex | 0 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | Overall, I felt that transcranial electrical stimulation treatment benefited me | 5.5 score on a scale | Standard Deviation 6.36 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The device was easy to use | 10 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I felt confident using the device | 10 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I felt the video conferences with a technical person were helpful | 10 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The effectiveness of the treatment increased over the course of treatment | 5 score on a scale | Standard Deviation 7.07 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I would imagine that most people would learn to use this device quickly | 10 score on a scale | Standard Deviation 0 |
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: 1. It was easy to prepare the device and accessories 2. The device was unnecessarily complex 3. The device was easy to use 4. I felt the video conferences with a technical person were helpful 5. I would imagine that most people would learn to use this device quickly 6. The device was cumbersome to use 7. I felt confident using the device 8. I needed to learn a lot of things before I could get going with this device 9. The effectiveness of the treatment increased over the course of treatment 10. Overall, I felt that transcranial electrical stimulation treatment benefited me
Time frame: 4 weeks of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | It was easy to prepare the device and accessories | 10 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The device was unnecessarily complex | 0 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The device was easy to use | 9 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I felt the video conferences with a technical person were helpful | 8 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I would imagine that most people would learn to use this device quickly | 8 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The device was cumbersome to use | 9 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I felt confident using the device | 10 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I needed to learn a lot of things before I could get going with this device | 1 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The effectiveness of the treatment increased over the course of treatment | 0 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | Overall, I felt that transcranial electrical stimulation treatment benefited me | 0 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I needed to learn a lot of things before I could get going with this device | 0 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | It was easy to prepare the device and accessories | 10 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The device was cumbersome to use | 0 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The device was unnecessarily complex | 0 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | Overall, I felt that transcranial electrical stimulation treatment benefited me | 7 score on a scale | Standard Deviation 4.24 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The device was easy to use | 10 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I felt confident using the device | 10 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I felt the video conferences with a technical person were helpful | 10 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The effectiveness of the treatment increased over the course of treatment | 7 score on a scale | Standard Deviation 4.24 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I would imagine that most people would learn to use this device quickly | 10 score on a scale | Standard Deviation 0 |
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: 1. It was easy to prepare the device and accessories 2. The device was unnecessarily complex 3. The device was easy to use 4. I felt the video conferences with a technical person were helpful 5. I would imagine that most people would learn to use this device quickly 6. The device was cumbersome to use 7. I felt confident using the device 8. I needed to learn a lot of things before I could get going with this device 9. The effectiveness of the treatment increased over the course of treatment 10. Overall, I felt that transcranial electrical stimulation treatment benefited me
Time frame: 6 weeks of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | It was easy to prepare the device and accessories | 9 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The device was unnecessarily complex | 0 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The device was easy to use | 9 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I felt the video conferences with a technical person were helpful | 10 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I would imagine that most people would learn to use this device quickly | 8 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The device was cumbersome to use | 7 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I felt confident using the device | 10 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I needed to learn a lot of things before I could get going with this device | 9 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The effectiveness of the treatment increased over the course of treatment | 0 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | Overall, I felt that transcranial electrical stimulation treatment benefited me | 0 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I needed to learn a lot of things before I could get going with this device | 0 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | It was easy to prepare the device and accessories | 10 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The device was cumbersome to use | 0 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The device was unnecessarily complex | 0 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | Overall, I felt that transcranial electrical stimulation treatment benefited me | 1.5 score on a scale | Standard Deviation 2.12 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The device was easy to use | 10 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I felt confident using the device | 10 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I felt the video conferences with a technical person were helpful | 10 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The effectiveness of the treatment increased over the course of treatment | 1.5 score on a scale | Standard Deviation 2.12 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I would imagine that most people would learn to use this device quickly | 10 score on a scale | Standard Deviation 0 |
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: 1. It was easy to prepare the device and accessories 2. The device was unnecessarily complex 3. The device was easy to use 4. I felt the video conferences with a technical person were helpful 5. I would imagine that most people would learn to use this device quickly 6. The device was cumbersome to use 7. I felt confident using the device 8. I needed to learn a lot of things before I could get going with this device 9. The effectiveness of the treatment increased over the course of treatment 10. Overall, I felt that transcranial electrical stimulation treatment benefited me
Time frame: 6 weeks post-treatment (12 weeks from baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | It was easy to prepare the device and accessories | 10 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The device was unnecessarily complex | 0 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The device was easy to use | 10 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I felt the video conferences with a technical person were helpful | 2 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I would imagine that most people would learn to use this device quickly | 3 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The device was cumbersome to use | 1 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I felt confident using the device | 10 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I needed to learn a lot of things before I could get going with this device | 1 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The effectiveness of the treatment increased over the course of treatment | 10 score on a scale | Standard Deviation 0 |
| Treatment | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | Overall, I felt that transcranial electrical stimulation treatment benefited me | 0 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I needed to learn a lot of things before I could get going with this device | 0 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | It was easy to prepare the device and accessories | 10 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The device was cumbersome to use | 0 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The device was unnecessarily complex | 0 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | Overall, I felt that transcranial electrical stimulation treatment benefited me | 5 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The device was easy to use | 10 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I felt confident using the device | 10 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I felt the video conferences with a technical person were helpful | 10 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | The effectiveness of the treatment increased over the course of treatment | 5 score on a scale | Standard Deviation 0 |
| Control Group | How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire | I would imagine that most people would learn to use this device quickly | 10 score on a scale | Standard Deviation 0 |
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.
Time frame: through study completion (about 12 weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants Included and Who Successfully Completed the Protocol | 1 Participants |
| Control Group | Number of Participants Included and Who Successfully Completed the Protocol | 2 Participants |
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.
Time frame: From baseline to week 12
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment | Safety of Home-based tDCS Treatment as Assessed by Side Effects | Tingling at site of contact with electrodes | 1 Participants |
| Treatment | Safety of Home-based tDCS Treatment as Assessed by Side Effects | Burning sensation at site of contact with electrodes | 1 Participants |
| Treatment | Safety of Home-based tDCS Treatment as Assessed by Side Effects | Fatigue | 0 Participants |
| Treatment | Safety of Home-based tDCS Treatment as Assessed by Side Effects | Difficulty concentrating | 0 Participants |
| Treatment | Safety of Home-based tDCS Treatment as Assessed by Side Effects | Mood change | 0 Participants |
| Treatment | Safety of Home-based tDCS Treatment as Assessed by Side Effects | Itching at site of contact with electrodes | 0 Participants |
| Control Group | Safety of Home-based tDCS Treatment as Assessed by Side Effects | Mood change | 1 Participants |
| Control Group | Safety of Home-based tDCS Treatment as Assessed by Side Effects | Tingling at site of contact with electrodes | 0 Participants |
| Control Group | Safety of Home-based tDCS Treatment as Assessed by Side Effects | Difficulty concentrating | 1 Participants |
| Control Group | Safety of Home-based tDCS Treatment as Assessed by Side Effects | Burning sensation at site of contact with electrodes | 0 Participants |
| Control Group | Safety of Home-based tDCS Treatment as Assessed by Side Effects | Itching at site of contact with electrodes | 1 Participants |
| Control Group | Safety of Home-based tDCS Treatment as Assessed by Side Effects | Fatigue | 1 Participants |
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.
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Apathy as Assessed by the Brief Dimensional Apathy Scale (b-DAS) | Treatment Week 2 (2 weeks from baseline) | 21 score on a scale | Standard Deviation 0 |
| Treatment | Apathy as Assessed by the Brief Dimensional Apathy Scale (b-DAS) | Treatment Week 6 (6 weeks from baseline) | 21 score on a scale | Standard Deviation 0 |
| Treatment | Apathy as Assessed by the Brief Dimensional Apathy Scale (b-DAS) | Treatment Week 4 (4 weeks from baseline) | 23 score on a scale | Standard Deviation 0 |
| Treatment | Apathy as Assessed by the Brief Dimensional Apathy Scale (b-DAS) | 6 weeks post-treatment (12 weeks from baseline) | 24 score on a scale | Standard Deviation 0 |
| Treatment | Apathy as Assessed by the Brief Dimensional Apathy Scale (b-DAS) | Baseline | 18 score on a scale | Standard Deviation 0 |
| Control Group | Apathy as Assessed by the Brief Dimensional Apathy Scale (b-DAS) | 6 weeks post-treatment (12 weeks from baseline) | 15.5 score on a scale | Standard Deviation 5.5 |
| Control Group | Apathy as Assessed by the Brief Dimensional Apathy Scale (b-DAS) | Baseline | 21 score on a scale | Standard Deviation 0 |
| Control Group | Apathy as Assessed by the Brief Dimensional Apathy Scale (b-DAS) | Treatment Week 2 (2 weeks from baseline) | 17.5 score on a scale | Standard Deviation 1.5 |
| Control Group | Apathy as Assessed by the Brief Dimensional Apathy Scale (b-DAS) | Treatment Week 4 (4 weeks from baseline) | 13 score on a scale | Standard Deviation 5 |
| Control Group | Apathy as Assessed by the Brief Dimensional Apathy Scale (b-DAS) | Treatment Week 6 (6 weeks from baseline) | 17 score on a scale | Standard Deviation 2 |
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
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Apathy as Measured by the Apathy Evaluation Scale (AES) | Baseline | 32 score on a scale | Standard Deviation 0 |
| Treatment | Apathy as Measured by the Apathy Evaluation Scale (AES) | Treatment Week 6 (6 weeks from baseline) | 41 score on a scale | Standard Deviation 0 |
| Treatment | Apathy as Measured by the Apathy Evaluation Scale (AES) | Treatment Week 2 (2 weeks from baseline) | 38 score on a scale | Standard Deviation 0 |
| Treatment | Apathy as Measured by the Apathy Evaluation Scale (AES) | 6 Weeks Post-Treatment (12 weeks from baseline) | 40 score on a scale | Standard Deviation 0 |
| Treatment | Apathy as Measured by the Apathy Evaluation Scale (AES) | Treatment Week 4 (4 weeks from baseline) | 43 score on a scale | Standard Deviation 0 |
| Control Group | Apathy as Measured by the Apathy Evaluation Scale (AES) | 6 Weeks Post-Treatment (12 weeks from baseline) | 47 score on a scale | Standard Deviation 8 |
| Control Group | Apathy as Measured by the Apathy Evaluation Scale (AES) | Baseline | 41 score on a scale | Standard Deviation 4 |
| Control Group | Apathy as Measured by the Apathy Evaluation Scale (AES) | Treatment Week 4 (4 weeks from baseline) | 45 score on a scale | Standard Deviation 3 |
| Control Group | Apathy as Measured by the Apathy Evaluation Scale (AES) | Treatment Week 6 (6 weeks from baseline) | 46 score on a scale | Standard Deviation 2 |
| Control Group | Apathy as Measured by the Apathy Evaluation Scale (AES) | Treatment Week 2 (2 weeks from baseline) | 42 score on a scale | Standard Deviation 4 |
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.
Time frame: Baseline, treatment week 6 (6 weeks from baseline), and 6 weeks post-treatment(12 weeks from baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Cognition as Evaluated by the Mini-Mental State Examination (MMSE) | Treatment Week 12 (12 weeks from baseline) | 28 score on a scale | Standard Deviation 0 |
| Treatment | Cognition as Evaluated by the Mini-Mental State Examination (MMSE) | Baseline | 26 score on a scale | Standard Deviation 0 |
| Treatment | Cognition as Evaluated by the Mini-Mental State Examination (MMSE) | Treatment Week 6 (6 weeks from baseline) | 23 score on a scale | Standard Deviation 0 |
| Control Group | Cognition as Evaluated by the Mini-Mental State Examination (MMSE) | Baseline | 23.5 score on a scale | Standard Deviation 2.5 |
| Control Group | Cognition as Evaluated by the Mini-Mental State Examination (MMSE) | Treatment Week 6 (6 weeks from baseline) | 25 score on a scale | Standard Deviation 1 |
| Control Group | Cognition as Evaluated by the Mini-Mental State Examination (MMSE) | Treatment Week 12 (12 weeks from baseline) | 24 score on a scale | Standard Deviation 4 |
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.
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Caregiver Distress Score) | Treatment Week 2 (2 weeks from baseline) | 5 score on a scale | Standard Deviation 0 |
| Treatment | Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Caregiver Distress Score) | Treatment Week 6 (6 weeks from baseline) | 6 score on a scale | Standard Deviation 0 |
| Treatment | Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Caregiver Distress Score) | Treatment Week 4 (4 weeks from baseline) | 5 score on a scale | Standard Deviation 0 |
| Treatment | Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Caregiver Distress Score) | 6 weeks Post-Treatment (12 weeks from baseline) | 6 score on a scale | Standard Deviation 0 |
| Treatment | Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Caregiver Distress Score) | Baseline | 3 score on a scale | Standard Deviation 0 |
| Control Group | Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Caregiver Distress Score) | 6 weeks Post-Treatment (12 weeks from baseline) | 10.5 score on a scale | Standard Deviation 10.5 |
| Control Group | Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Caregiver Distress Score) | Baseline | 13 score on a scale | Standard Deviation 6 |
| Control Group | Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Caregiver Distress Score) | Treatment Week 2 (2 weeks from baseline) | 11.5 score on a scale | Standard Deviation 9.5 |
| Control Group | Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Caregiver Distress Score) | Treatment Week 4 (4 weeks from baseline) | 6 score on a scale | Standard Deviation 3 |
| Control Group | Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Caregiver Distress Score) | Treatment Week 6 (6 weeks from baseline) | 7 score on a scale | Standard Deviation 5 |
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.
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Severity Score) | treatment week 2 (2 weeks from baseline) | 5 score on a scale | Standard Deviation 0 |
| Treatment | Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Severity Score) | treatment week 6 (6 weeks from baseline) | 10 score on a scale | Standard Deviation 0 |
| Treatment | Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Severity Score) | treatment week 4 (4 weeks from baseline) | 6 score on a scale | Standard Deviation 0 |
| Treatment | Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Severity Score) | 6 weeks post-treatment (12 weeks from baseline) | 10 score on a scale | Standard Deviation 0 |
| Treatment | Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Severity Score) | Baseline | 9 score on a scale | Standard Deviation 0 |
| Control Group | Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Severity Score) | 6 weeks post-treatment (12 weeks from baseline) | 8.5 score on a scale | Standard Deviation 8.5 |
| Control Group | Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Severity Score) | Baseline | 12.5 score on a scale | Standard Deviation 7.5 |
| Control Group | Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Severity Score) | treatment week 2 (2 weeks from baseline) | 14 score on a scale | Standard Deviation 12 |
| Control Group | Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Severity Score) | treatment week 4 (4 weeks from baseline) | 9.5 score on a scale | Standard Deviation 6.5 |
| Control Group | Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Severity Score) | treatment week 6 (6 weeks from baseline) | 10 score on a scale | Standard Deviation 6 |
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.
Time frame: Baseline, treatment week 6 (6 weeks from baseline), and 6 weeks post-treatment (12 weeks from baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Depressive Symptoms as Assessed by the Cornell Scale for Depression in Dementia | Baseline | 13 score on a scale | Standard Deviation 0 |
| Treatment | Depressive Symptoms as Assessed by the Cornell Scale for Depression in Dementia | treatment week 6 (6 weeks from baseline) | 9 score on a scale | Standard Deviation 0 |
| Treatment | Depressive Symptoms as Assessed by the Cornell Scale for Depression in Dementia | 6 weeks post-treatment (12 weeks from baseline) | 9 score on a scale | Standard Deviation 0 |
| Control Group | Depressive Symptoms as Assessed by the Cornell Scale for Depression in Dementia | Baseline | 12 score on a scale | Standard Deviation 3 |
| Control Group | Depressive Symptoms as Assessed by the Cornell Scale for Depression in Dementia | treatment week 6 (6 weeks from baseline) | 8.5 score on a scale | Standard Deviation 3.5 |
| Control Group | Depressive Symptoms as Assessed by the Cornell Scale for Depression in Dementia | 6 weeks post-treatment (12 weeks from baseline) | 9 score on a scale | Standard Deviation 3 |