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PI moved to a new institution
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| Name | Class |
|---|---|
| Texas Alzheimer's Research and Care Consortium | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
| |
| Control Group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| home-based active tDCS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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:
| 2 weeks of treatment |
| How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio L Teixeira Jr, MD.PhD,MSc | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37147739 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | through study completion (about 12 weeks) |
|
6 weeks post treatment (12 weeks from baseline)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tingling at site of contact with electrodes | General disorders | Systematic Assessment |
Did not meet enrollment target, resulting in small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Antonio L. Teixeira, MD, PhD, MSc | The University of Texas Health Science Center at Houston | 713-486-2555 | Antonio.L.Teixeira@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 8, 2021 | Jan 12, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| home-based sham tDCS | Device | For sham stimulation, electric current will be applied only in the first 30s tDCS. All sessions will be remotely supervised by trained research staff. |
|
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:
|
| 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:
| 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:
| 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 |
| 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. | 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) | 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. | 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 | 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. | 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) | 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. | Baseline, treatment week 6 (6 weeks from baseline), and 6 weeks post-treatment(12 weeks from baseline) |
| 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 | 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) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Comorbidities | Count of Participants | Participants |
|
| Medications in use | Count of Participants | Participants |
|
| Time Since Diagnosis | Mean | Standard Deviation | years |
|
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. |
|
|
| 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:
| Data were not collected for this outcome measure. | Posted | Baseline |
|
|
| 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:
| Posted | Mean | Standard Deviation | score on a scale | 2 weeks of treatment |
|
|
|
| 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:
| Posted | Mean | Standard Deviation | score on a scale | 4 weeks of treatment |
|
|
|
| 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:
| Posted | Mean | Standard Deviation | score on a scale | 6 weeks of treatment |
|
|
|
| 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:
| Posted | Mean | Standard Deviation | score on a scale | 6 weeks post-treatment (12 weeks from baseline) |
|
|
|
| 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. | Posted | Count of Participants | Participants | From baseline to week 12 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 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) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 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) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 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) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, treatment week 6 (6 weeks from baseline), and 6 weeks post-treatment (12 weeks from baseline) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, treatment week 6 (6 weeks from baseline), and 6 weeks post-treatment(12 weeks from baseline) |
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 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) |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | 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. | 0 | 2 | 0 | 2 | 2 | 2 |
| Burning sensation at site of contact with electrodes | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Difficulty concentrating | General disorders | Systematic Assessment |
|
| Mood Change | General disorders | Systematic Assessment |
|
| Itching at site of contact with electrodes | General disorders | Systematic Assessment |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| The device was easy to use |
|
| I felt the video conferences with a technical person were helpful |
|
| I would imagine that most people would learn to use this device quickly |
|
| The device was cumbersome to use |
|
| I felt confident using the device |
|
| I needed to learn a lot of things before I could get going with this device |
|
| The effectiveness of the treatment increased over the course of treatment |
|
| Overall, I felt that transcranial electrical stimulation treatment benefited me |
|
| The device was easy to use |
|
| I felt the video conferences with a technical person were helpful |
|
| I would imagine that most people would learn to use this device quickly |
|
| The device was cumbersome to use |
|
| I felt confident using the device |
|
| I needed to learn a lot of things before I could get going with this device |
|
| The effectiveness of the treatment increased over the course of treatment |
|
| Overall, I felt that transcranial electrical stimulation treatment benefited me |
|
| The device was easy to use |
|
| I felt the video conferences with a technical person were helpful |
|
| I would imagine that most people would learn to use this device quickly |
|
| The device was cumbersome to use |
|
| I felt confident using the device |
|
| I needed to learn a lot of things before I could get going with this device |
|
| The effectiveness of the treatment increased over the course of treatment |
|
| Overall, I felt that transcranial electrical stimulation treatment benefited me |
|
| The device was easy to use |
|
| I felt the video conferences with a technical person were helpful |
|
| I would imagine that most people would learn to use this device quickly |
|
| The device was cumbersome to use |
|
| I felt confident using the device |
|
| I needed to learn a lot of things before I could get going with this device |
|
| The effectiveness of the treatment increased over the course of treatment |
|
| Overall, I felt that transcranial electrical stimulation treatment benefited me |
|
| Fatigue |
|
| Difficulty concentrating |
|
| Mood change |
|
| Itching at site of contact with electrodes |
|
| Treatment Week 4 (4 weeks from baseline) |
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| Treatment Week 6 (6 weeks from baseline) |
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| 6 weeks post-treatment (12 weeks from baseline) |
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| treatment week 4 (4 weeks from baseline) |
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| treatment week 6 (6 weeks from baseline) |
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| 6 weeks post-treatment (12 weeks from baseline) |
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| Treatment Week 4 (4 weeks from baseline) |
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| Treatment Week 6 (6 weeks from baseline) |
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| 6 weeks Post-Treatment (12 weeks from baseline) |
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| 6 weeks post-treatment (12 weeks from baseline) |
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| Treatment Week 12 (12 weeks from baseline) |
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| Treatment Week 4 (4 weeks from baseline) |
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| Treatment Week 6 (6 weeks from baseline) |
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| 6 Weeks Post-Treatment (12 weeks from baseline) |
|