Alzheimer Disease and Related DementiasNCT04855643
Home-based tDCS for Apathy in Alzheimer's Disease
A study testing home-based active tDCS in people with Alzheimer Disease and Related Dementias, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease and Related Dementias
- What is being tested?
- home-based active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2021to 10 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Home-based Transcranial Direct Current Stimulation (tDCS) for Apathy in Alzheimer's Disease and Related Dementias (ADRD)
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.
- Conditions
- Alzheimer Disease and Related Dementias
- Being tested
- home-based active tDCS, home-based sham tDCS
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home-based active tDCSDevice
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.
home-based sham tDCSDevice
For sham stimulation, electric current will be applied only in the first 30s tDCS. All sessions will be remotely supervised by trained research staff.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: home-based active tDCS |
| Control Group | Sham comparator | Not described Receives: Device: home-based sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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:
- It was easy to prepare the device and accessories
- The device was unnecessarily complex
- 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
Measured: 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:
- It was easy to prepare the device and accessories
- The device was unnecessarily complex
- 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
Measured: 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:
- It was easy to prepare the device and accessories
- The device was unnecessarily complex
- 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
Measured: 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:
- It was easy to prepare the device and accessories
- The device was unnecessarily complex
- 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
Measured: 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:
- It was easy to prepare the device and accessories
- The device was unnecessarily complex
- 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
Measured: 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.
Measured: From baseline to week 12
Secondary outcomes (6)
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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start20 Aug 2021
- Primary completion10 Jul 2022
- Study completion10 Jul 2022
Why it stopped: PI moved to a new institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer Disease and Related DementiasStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Alzheimer's Research and Care Consortium
- Responsible party
- Principal investigator, Antonio L. Teixeira, The University of Texas Health Science Center, Houston
- Investigators
- Antonio L Teixeira Jr, MD.PhD,MSc, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855643
- Sponsor's protocol ID
- HSC-MS-21-0089
- Status last verified
- Mar 2024
- First submitted
- 15 Apr 2021
- Last updated
- 23 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37147739
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Transcranial Direct Current Stimulation (tDCS) for Apathy in Alzheimer's Disease and Related Dementias (ADRD)
- ClinicalTrials.gov ID
- NCT04855643
- Acronym / sponsor ID
- HSC-MS-21-0089
- Conditions
- Alzheimer Disease and Related Dementias
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI moved to a new institution
- Enrolment
- 3 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Texas Alzheimer's Research and Care Consortium
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 10 Jul 2022 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Posted 23 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: home-based active tDCS |
| Control Group | Sham comparator | Device: home-based sham tDCS |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| home-based active tDCSAnode 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. | Device | Treatment |
| home-based sham tDCSFor sham stimulation, electric current will be applied only in the first 30s tDCS. All sessions will be remotely supervised by trained research staff. | Device | Control Group |
Primary outcome
Number of Participants Included and Who Successfully Completed the Protocol
Time frame: 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
Time frame: 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
How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire
Time frame: 2 weeks of treatment
Acceptability will be measured using a Likert scale composed by 10 questions, each one ranging from 0 (strongly disagree) to 10 (strongly agree). 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
How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire
Time frame: 4 weeks of treatment
Acceptability will be measured using a Likert scale composed by 10 questions, each one ranging from 0 (strongly disagree) to 10 (strongly agree). 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
How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire
Time frame: 6 weeks of treatment
Acceptability will be measured using a Likert scale composed by 10 questions, each one ranging from 0 (strongly disagree) to 10 (strongly agree). 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
How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire
Time frame: 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
Safety of Home-based tDCS Treatment as Assessed by Side Effects
Time frame: From baseline to week 12
Safety will be assessed with a questionnaire about side effects that include itching, burning, headache, fatigue, and dizziness.
6 secondary outcomes
Apathy as Assessed by the Brief Dimensional Apathy Scale (b-DAS)
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)
Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Severity Score)
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)
Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Caregiver Distress Score)
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)
Depressive Symptoms as Assessed by the Cornell Scale for Depression in Dementia
Time frame: 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)
Time frame: 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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37147739Teixeira 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio L Teixeira Jr, MD.PhD,MSc principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home-based active tDCS in people with Alzheimer Disease and Related Dementias, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Included and Who Successfully Completed the Protocol (time frame: through study completion (about 12 weeks)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04855643, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.