Home-based tDCS for Apathy in Alzheimer's Disease

NCT04855643 | Terminated Results FDA Device

• 1 other identifier: HSC-MS-21-0089
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess feasibility, acceptability, and safety of providing tDCS to Alzheimer's disease and related dementias (ADRD) patients with apathy and to assess the efficacy of tDCS for ADRD-related symptoms, with a primary focus on apathy.

Conditions

Alzheimer Disease and Related Dementias

Outcome Measures

Primary Outcomes (7)

• 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

Secondary Outcomes (6)

• 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)

Study Arms (2)

Treatment

EXPERIMENTAL

Device: home-based active tDCS

Control Group

SHAM COMPARATOR

Device: home-based sham tDCS

Interventions

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.

Treatment

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.

Control Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Texas Alzheimer's Research and Care Consortium: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 37147739 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

Did not meet enrollment target, resulting in small numbers of subjects analyzed.

Results Point of Contact

• Title: Antonio L. Teixeira, MD, PhD, MSc
• Organization: The University of Texas Health Science Center at Houston

Antonio.L.Teixeira@uth.tmc.edu

713-486-2555

Study Officials

• Antonio L Teixeira Jr, MD.PhD,MSc

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: April 22, 2021
• Study Start: August 20, 2021
• Primary Completion: July 10, 2022
• Study Completion: July 10, 2022
• Last Updated: April 23, 2024
• Results First Posted: April 23, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)