Home-based Transcranial Direct Current Stimulation (tDCS) for Behavioral Symptoms in Alzheimer's Disease and Related Dementias (ADRD)

Alzheimer Disease Clinical Trial

Official title:

Home-based tDCS for Behavioral Symptoms in Alzheimer's Disease and Related Dementias (ADRD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05478681
• Other study ID #: HSC-MS-22-0296
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: January 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: Kendra M Anderson, PhD
• Phone: (713) 486-0513
• Email: Kendra.M.Anderson[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess acceptability, and safety of providing tDCS to ADRD patients with behavioral symptoms and to assess the efficacy of tDCS for ADRD-related symptoms, mainly behavioral symptoms.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• have ADRD and clinically-meaningful behavioral symptoms

• have a caregiver willing to participate in the study

• can speak and read English

• have stable doses of medications for at least one month

Exclusion Criteria:

• any unstable concurrent medical conditions

• history of brain surgery

• seizure

• intracranial metal implantation

• current alcohol/substance use disorder

Related Conditions & MeSH terms

• Alzheimer Disease
• Behavioral Symptoms
• Dementia

Intervention

Device:
• active tDCS
All participants will receive active tDCS with a constant current intensity of 2mA. Anodal tDCS will be applied to the left dorsolateral prefrontal cortex, while cathodal electrode will be positioned on the right dorsolateral prefrontal cortex. Caregivers will help setting up and administering tDCS for participants with AD at home. tDCS will be applied for 30min at an intensity of 2mA, with 30 s ramping up and down.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Texas Alzheimer's Research & Care Consortium (TARCC)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of the tDCS treatment as assessed by the tDCS acceptability questionnaire	This scale will ask 10 questions and each question will be rated form 0(strongly agree) to 10(strongly disagree) for a total score of 100, a higher number indicating higher acceptance of the tDCS treatment	week 2
Primary	Acceptability of the tDCS treatment as assessed by the tDCS acceptability questionnaire	This scale will ask 10 questions and each question will be rated form 0(strongly agree) to 10(strongly disagree) for a total score of 100, a higher number indicating higher acceptance of the tDCS treatment	week 4
Primary	Acceptability of the tDCS treatment as assessed by the tDCS acceptability questionnaire	This scale will ask 10 questions and each question will be rated form 0(strongly agree) to 10(strongly disagree) for a total score of 100, a higher number indicating higher acceptance of the tDCS treatment	week 6
Primary	Acceptability of the tDCS treatment as assessed by the tDCS acceptability questionnaire	This scale will ask 10 questions and each question will be rated form 0(strongly agree) to 10(strongly disagree) for a total score of 100, a higher number indicating higher acceptance of the tDCS treatment	week 12
Primary	safety as assessed by the side effects questionnaire	side effects include itching, burning, headache, fatigue, and dizziness.	week 2
Primary	safety as assessed by the side effects questionnaire	side effects include itching, burning, headache, fatigue, and dizziness.	week 4
Primary	safety as assessed by the side effects questionnaire	side effects include itching, burning, headache, fatigue, and dizziness.	week 6
Secondary	Change in dementia-related behavioral symptoms as assessed by the Neuropsychiatric Inventory (NPI-Q) scale	NPI-Q evaluates 12 discrete neuropsychiatric symptoms considering their severity and the related caregiver distress.	Baseline, week 2, week 4, week 6, 6 weeks post treatment
Secondary	Change in 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), higher scores indicate more apathy	Baseline, Week 6 and Week 12.
Secondary	Change in depressive symptoms as assessed by the Cornell Scale for Depression in Dementia (CSDD)	This questionnaire has 19 questions and each is scored from 0(absent) to 2(severe). A total score greater than 10 indicates probable major depressive episode and a score of greater than 18 indicates definite major depressive episode	Baseline, Week 6 and Week 12.
Secondary	Change in cognition as evaluated by the Mini-Mental State Examination (MMSE)	Mini-Mental State Examination (MMSE) includes memory, language, praxis and orientation tasks, yielding a global cognition score ranging 0 to 30, with higher scores indicating better performance.	Baseline, Week 6 and Week 12.