Trial Outcomes & Findings for Home-based tDCS for Apathy in Alzheimer's Disease (NCT NCT04855643)
NCT ID: NCT04855643
Last Updated: 2024-04-23
Results Overview
The feasibility will be assessed based on the recruitment rate (per month), randomization success, blind success, retention, and attrition rates.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
through study completion (about 12 weeks)
Results posted on
2024-04-23
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Home-based tDCS for Apathy in Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Treatment
n=1 Participants
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.
|
Control Group
n=2 Participants
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.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
79 years
STANDARD_DEVIATION 0 • n=5 Participants
|
82 years
STANDARD_DEVIATION 5 • n=7 Participants
|
81 years
STANDARD_DEVIATION 4.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Comorbidities
Dyslipidemia
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Comorbidities
Hypertension
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Comorbidities
Glaucoma
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Comorbidities
Osteoarthritis
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Medications in use
Aspirin
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medications in use
Atorvastatin
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Medications in use
Tamsulosin
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medications in use
Citalopram
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medications in use
Hydrochlorothiazide
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medications in use
Vitamin B12
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medications in use
Vitamin D
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medications in use
Donapezil
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Medications in use
Memantine
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Medications in use
Pregabalin
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medications in use
Sertraline
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medications in use
Amlodipine
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Medications in use
Rosuvastatin
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medications in use
Cilostasol
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medications in use
Duloxetine
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medications in use
Carvedilol
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medications in use
Clopidogrel
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medications in use
Eliquis
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Time Since Diagnosis
|
3 years
STANDARD_DEVIATION 0 • n=5 Participants
|
3.5 years
STANDARD_DEVIATION 1.5 • n=7 Participants
|
3.33 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Treatment
n=1 Participants
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.
|
Control Group
n=2 Participants
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.
|
|---|---|---|
|
Number of Participants Included and Who Successfully Completed the Protocol
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Data were not collected for this outcome measure.
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
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 2 weeks of treatmentAcceptability 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
Outcome measures
| Measure |
Treatment
n=1 Participants
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.
|
Control Group
n=2 Participants
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.
|
|---|---|---|
|
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
|
10 score on a scale
Standard Deviation 0
|
|
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
|
0 score on a scale
Standard Deviation 0
|
|
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
|
10 score on a scale
Standard Deviation 0
|
|
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
|
10 score on a scale
Standard Deviation 0
|
|
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
|
10 score on a scale
Standard Deviation 0
|
|
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
|
0 score on a scale
Standard Deviation 0
|
|
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
|
10 score on a scale
Standard Deviation 0
|
|
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
|
0 score on a scale
Standard Deviation 0
|
|
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
|
5 score on a scale
Standard Deviation 7.07
|
|
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
|
5.5 score on a scale
Standard Deviation 6.36
|
PRIMARY outcome
Timeframe: 4 weeks of treatmentAcceptability 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
Outcome measures
| Measure |
Treatment
n=1 Participants
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.
|
Control Group
n=2 Participants
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.
|
|---|---|---|
|
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
|
10 score on a scale
Standard Deviation 0
|
|
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
|
0 score on a scale
Standard Deviation 0
|
|
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
|
10 score on a scale
Standard Deviation 0
|
|
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
|
10 score on a scale
Standard Deviation 0
|
|
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
|
10 score on a scale
Standard Deviation 0
|
|
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
|
0 score on a scale
Standard Deviation 0
|
|
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
|
10 score on a scale
Standard Deviation 0
|
|
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
|
0 score on a scale
Standard Deviation 0
|
|
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
|
7 score on a scale
Standard Deviation 4.24
|
|
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
|
7 score on a scale
Standard Deviation 4.24
|
PRIMARY outcome
Timeframe: 6 weeks of treatmentAcceptability 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
Outcome measures
| Measure |
Treatment
n=1 Participants
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.
|
Control Group
n=2 Participants
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.
|
|---|---|---|
|
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
|
10 score on a scale
Standard Deviation 0
|
|
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
|
0 score on a scale
Standard Deviation 0
|
|
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
|
10 score on a scale
Standard Deviation 0
|
|
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
|
10 score on a scale
Standard Deviation 0
|
|
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
|
10 score on a scale
Standard Deviation 0
|
|
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
|
0 score on a scale
Standard Deviation 0
|
|
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
|
10 score on a scale
Standard Deviation 0
|
|
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
|
0 score on a scale
Standard Deviation 0
|
|
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
|
1.5 score on a scale
Standard Deviation 2.12
|
|
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
|
1.5 score on a scale
Standard Deviation 2.12
|
PRIMARY outcome
Timeframe: 6 weeks post-treatment (12 weeks from 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
Outcome measures
| Measure |
Treatment
n=1 Participants
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.
|
Control Group
n=2 Participants
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.
|
|---|---|---|
|
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
|
10 score on a scale
Standard Deviation 0
|
|
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
|
0 score on a scale
Standard Deviation 0
|
|
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
|
10 score on a scale
Standard Deviation 0
|
|
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
|
10 score on a scale
Standard Deviation 0
|
|
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
|
10 score on a scale
Standard Deviation 0
|
|
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
|
0 score on a scale
Standard Deviation 0
|
|
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
|
10 score on a scale
Standard Deviation 0
|
|
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
|
0 score on a scale
Standard Deviation 0
|
|
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
|
5 score on a scale
Standard Deviation 0
|
|
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
|
5 score on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: From baseline to week 12Safety will be assessed with a questionnaire about side effects that include itching, burning, headache, fatigue, and dizziness.
Outcome measures
| Measure |
Treatment
n=1 Participants
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.
|
Control Group
n=2 Participants
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.
|
|---|---|---|
|
Safety of Home-based tDCS Treatment as Assessed by Side Effects
Fatigue
|
0 Participants
|
1 Participants
|
|
Safety of Home-based tDCS Treatment as Assessed by Side Effects
Tingling at site of contact with electrodes
|
1 Participants
|
0 Participants
|
|
Safety of Home-based tDCS Treatment as Assessed by Side Effects
Burning sensation at site of contact with electrodes
|
1 Participants
|
0 Participants
|
|
Safety of Home-based tDCS Treatment as Assessed by Side Effects
Difficulty concentrating
|
0 Participants
|
1 Participants
|
|
Safety of Home-based tDCS Treatment as Assessed by Side Effects
Mood change
|
0 Participants
|
1 Participants
|
|
Safety of Home-based tDCS Treatment as Assessed by Side Effects
Itching at site of contact with electrodes
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Treatment
n=1 Participants
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.
|
Control Group
n=2 Participants
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.
|
|---|---|---|
|
Apathy as Assessed by the Brief Dimensional Apathy Scale (b-DAS)
Baseline
|
18 score on a scale
Standard Deviation 0
|
21 score on a scale
Standard Deviation 0
|
|
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
|
17.5 score on a scale
Standard Deviation 1.5
|
|
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
|
13 score on a scale
Standard Deviation 5
|
|
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
|
17 score on a scale
Standard Deviation 2
|
|
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
|
15.5 score on a scale
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Treatment
n=1 Participants
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.
|
Control Group
n=2 Participants
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.
|
|---|---|---|
|
Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Severity Score)
Baseline
|
9 score on a scale
Standard Deviation 0
|
12.5 score on a scale
Standard Deviation 7.5
|
|
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
|
14 score on a scale
Standard Deviation 12
|
|
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
|
9.5 score on a scale
Standard Deviation 6.5
|
|
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
|
10 score on a scale
Standard Deviation 6
|
|
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
|
8.5 score on a scale
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Treatment
n=1 Participants
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.
|
Control Group
n=2 Participants
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.
|
|---|---|---|
|
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
|
13 score on a scale
Standard Deviation 6
|
|
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
|
11.5 score on a scale
Standard Deviation 9.5
|
|
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
|
6 score on a scale
Standard Deviation 3
|
|
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
|
7 score on a scale
Standard Deviation 5
|
|
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
|
10.5 score on a scale
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Treatment
n=1 Participants
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.
|
Control Group
n=2 Participants
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.
|
|---|---|---|
|
Depressive Symptoms as Assessed by the Cornell Scale for Depression in Dementia
Baseline
|
13 score on a scale
Standard Deviation 0
|
12 score on a scale
Standard Deviation 3
|
|
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
|
8.5 score on a scale
Standard Deviation 3.5
|
|
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
|
9 score on a scale
Standard Deviation 3
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Treatment
n=1 Participants
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.
|
Control Group
n=2 Participants
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.
|
|---|---|---|
|
Cognition as Evaluated by the Mini-Mental State Examination (MMSE)
Baseline
|
26 score on a scale
Standard Deviation 0
|
23.5 score on a scale
Standard Deviation 2.5
|
|
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
|
25 score on a scale
Standard Deviation 1
|
|
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
|
24 score on a scale
Standard Deviation 4
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Treatment
n=1 Participants
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.
|
Control Group
n=2 Participants
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.
|
|---|---|---|
|
Apathy as Measured by the Apathy Evaluation Scale (AES)
Baseline
|
32 score on a scale
Standard Deviation 0
|
41 score on a scale
Standard Deviation 4
|
|
Apathy as Measured by the Apathy Evaluation Scale (AES)
Treatment Week 2 (2 weeks from baseline)
|
38 score on a scale
Standard Deviation 0
|
42 score on a scale
Standard Deviation 4
|
|
Apathy as Measured by the Apathy Evaluation Scale (AES)
Treatment Week 4 (4 weeks from baseline)
|
43 score on a scale
Standard Deviation 0
|
45 score on a scale
Standard Deviation 3
|
|
Apathy as Measured by the Apathy Evaluation Scale (AES)
Treatment Week 6 (6 weeks from baseline)
|
41 score on a scale
Standard Deviation 0
|
46 score on a scale
Standard Deviation 2
|
|
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
|
47 score on a scale
Standard Deviation 8
|
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment
n=1 participants at risk
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.
|
Control Group
n=2 participants at risk
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.
|
|---|---|---|
|
General disorders
Itching at site of contact with electrodes
|
0.00%
0/1 • 6 weeks post treatment (12 weeks from baseline)
|
50.0%
1/2 • 6 weeks post treatment (12 weeks from baseline)
|
|
General disorders
Tingling at site of contact with electrodes
|
100.0%
1/1 • 6 weeks post treatment (12 weeks from baseline)
|
0.00%
0/2 • 6 weeks post treatment (12 weeks from baseline)
|
|
General disorders
Burning sensation at site of contact with electrodes
|
100.0%
1/1 • 6 weeks post treatment (12 weeks from baseline)
|
0.00%
0/2 • 6 weeks post treatment (12 weeks from baseline)
|
|
General disorders
Fatigue
|
0.00%
0/1 • 6 weeks post treatment (12 weeks from baseline)
|
50.0%
1/2 • 6 weeks post treatment (12 weeks from baseline)
|
|
General disorders
Difficulty concentrating
|
0.00%
0/1 • 6 weeks post treatment (12 weeks from baseline)
|
50.0%
1/2 • 6 weeks post treatment (12 weeks from baseline)
|
|
General disorders
Mood Change
|
0.00%
0/1 • 6 weeks post treatment (12 weeks from baseline)
|
50.0%
1/2 • 6 weeks post treatment (12 weeks from baseline)
|
Additional Information
Antonio L. Teixeira, MD, PhD, MSc
The University of Texas Health Science Center at Houston
Phone: 713-486-2555
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place