NCT04855643|TerminatedResultsFDA Device
Study Stopped
PI moved to a new institution
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Home-based Transcranial Direct Current Stimulation (tDCS) for Apathy in Alzheimer's Disease and Related Dementias (ADRD)
Sponsor study identifier
interventional
3
1 country
1
Study Start
August 20, 2021
Actual (reported)Primary Completion
July 10, 2022
Actual (reported)Study Completion
July 10, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 10, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 15, 2021
Actual (reported)April 22, 2021
Actual (reported)August 20, 2021
Actual (reported)July 10, 2022
Actual (reported)July 10, 2022
Actual (reported)April 23, 2024
Actual (reported)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.
through study completion (about 12 weeks)
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
Baseline
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
2 weeks of treatment
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
4 weeks of treatment
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
6 weeks of treatment
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
6 weeks post-treatment (12 weeks from baseline)
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.
From baseline to week 12
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)
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)
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)
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)
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)
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.
For sham stimulation, electric current will be applied only in the first 30s tDCS. All sessions will be remotely supervised by trained research staff.
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Teixeira AL, Martins LB, Cordeiro TME, Jose L, Suchting R, Holmes HM, Acierno R, Ahn H. Home-based tDCS for apathy in Alzheimer's disease: a protocol for a randomized double-blinded controlled pilot study. Pilot Feasibility Stud. 2023 May 5;9(1):74. doi: 10.1186/s40814-023-01310-5.
Did not meet enrollment target, resulting in small numbers of subjects analyzed.
Antonio L Teixeira Jr, MD.PhD,MSc
The University of Texas Health Science Center, Houston
3 participants (actual enrollment reported by the registry).
First Submitted
April 15, 2021
First Posted
April 22, 2021
Study Start
August 20, 2021
Actual (reported)SmartEnLite for Nursing Home Residents With Dementia
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
July 10, 2022
Actual (reported)Study Completion
July 10, 2022
Actual (reported)Last Updated
April 23, 2024
Results First Posted
April 23, 2024
Record last verified: 2024-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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