Home-based Transcranial Direct Current Stimulation Open Trial for Behavioral and Cognitive Symptoms in Huntington's Disease
Primary Purpose
Huntington Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
active tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Huntington Disease focused on measuring transcranial direct current stimulation
Eligibility Criteria
Participant:
Inclusion Criteria:
- confirmed HD mutation carriers
- early (stages 1 and 2) or moderate (stage 3) stages according to Shoulson-Fahn
- exhibit mild to moderate behavioral symptoms, such as clinically diagnosed apathy, irritability, anxiety, depression, aggression and repetition
- stable doses of medications for at least one month
Exclusion Criteria:
- unstable medical conditions
- history of epilepsy
- metallic objects in the brain
- clinical diagnosis of major cognitive disorder or dementia
- Have risk of suicidal behavior, defined as any suicidal behavior or suicidal ideation of type 4
Caregiver:
Inclusion Criteria:
-willingness to participate in the study
Exclusion Criteria:
-motor/cognitive symptoms related to Alzheimer's disease or Huntington's disease that might impair the ability to assist the participant during the research study.
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
active tDCS
Arm Description
Outcomes
Primary Outcome Measures
Number of participants included and who successfully completed the protocol.
The feasibility will be assessed based on the recruitment rate (per month), retention,and attrition rates
Change in acceptability of the treatment as assessed by the tDCS acceptability questionnaire
Acceptability will be evaluated using Likert scale (from 0 [strongly disagree] to 10 [strongly agree]) to answer ten affirmatives regarding the use of home based tDCS.
Change in safety of the home-based tDCS treatment as measured by reporting side effects using the tDCS questionnaire
Safety will be assessed with a 10 item questionnaire about side effects that include itching, burning, headache, fatigue, and dizziness.Each question is scored form 0-10, higher number indicating more side effects
Secondary Outcome Measures
Change in Motor function as assessed by the Unified Huntington Disease Rating Scale (UHDRS)
.This scale has 31 items with 5-point ordinal scale ranging rom 0-4 with the highest score indicating inability to perform the motor task
Change in Cognitive function as assessed by the Unified Huntington Disease Rating Scale (UHDRS)
.This scale has 3 items with higher scores indicating better cognitive performance
Change in behavioral assessment as assessed by the Unified Huntington Disease Rating Scale (UHDRS)
This scale has 10 items with a 5-point ordinal scale ranging form 0-4 with the highest score indicating severe behavioral symptoms.
Change in apathy as assessed by the Brief Dimensional Apathy Scale (bDAS)
This scale consists of 9 questions each one scored from 0(almost always) to 3(hardly ever), higher scores indicate more apathy
Change in depression as assessed by the Patient Health Questionnaire (PHQ-9)
This questionnaire has 9 questions and each is scored form 0(not at all)-3(nearly every day) with a total score of 27, a higher number indicating more depression.
Change in irritability as assessed by the Irritability Questionnaire
This is a 21 item questionnaire and each item is scored form 0(never)-3(most of the time) for a maximum score of 63, a higher number indicating more irritability
Change in cognition as assessed by the Montreal Cognitive Assessment (MoCA),
This is scored from 0-30 with higher scores indicating better performance
Change in Anxiety and depressive symptoms will assessed using the Hospital Anxiety and Depression Scale (HADS).
HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score greater than 8 denotes anxiety or depression.
Change in behavioral symptoms as assessed by the Problem Behaviours Assessment (PBA-s)
Each symptom is rated for severity on a 5-point scale : 0 = "not at all"; 1 = trivial; 2 = mild; 3 = moderate (disrupting everyday activities) and 4 = severe or intolerable. Each symptom is also scored for frequency on a 5-point scale as follows: 0 = symptom absent; 1 = less than once weekly; 2 = at least once a week; 3 = most days (up to and including some part of everyday); and 4 = all day, every day. Severity and frequency scores are multiplied to produce an overall 'PBA score' for each symptom.
Full Information
NCT ID
NCT05326451
First Posted
April 5, 2022
Last Updated
April 5, 2022
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT05326451
Brief Title
Home-based Transcranial Direct Current Stimulation Open Trial for Behavioral and Cognitive Symptoms in Huntington's Disease
Official Title
Home-based Transcranial Direct Current Stimulation Open Trial for Behavioral and Cognitive Symptoms in Huntington's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 15, 2022 (Anticipated)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess feasibility, acceptability, and safety of providing transcranial direct current stimulation( tDCS) to Huntingtons Disease (HD) patients in the early to middle stages and to assess the efficacy of tDCS for HD-related behavioral, cognitive and other symptoms
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington Disease
Keywords
transcranial direct current stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
active tDCS
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
active tDCS
Intervention Description
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 HD at home. tDCS will be applied for 30min at an intensity of 2mA, with 30 s ramping up and down. Sessions will be remotely supervised by trained research staff (RA), and will run from Monday through Friday for four consecutive weeks.
Primary Outcome Measure Information:
Title
Number of participants included and who successfully completed the protocol.
Description
The feasibility will be assessed based on the recruitment rate (per month), retention,and attrition rates
Time Frame
through study completion, an average of 8 weeks
Title
Change in acceptability of the treatment as assessed by the tDCS acceptability questionnaire
Description
Acceptability will be evaluated using Likert scale (from 0 [strongly disagree] to 10 [strongly agree]) to answer ten affirmatives regarding the use of home based tDCS.
Time Frame
Baseline, week 2, week 4, week 8
Title
Change in safety of the home-based tDCS treatment as measured by reporting side effects using the tDCS questionnaire
Description
Safety will be assessed with a 10 item questionnaire about side effects that include itching, burning, headache, fatigue, and dizziness.Each question is scored form 0-10, higher number indicating more side effects
Time Frame
week 2, week 4
Secondary Outcome Measure Information:
Title
Change in Motor function as assessed by the Unified Huntington Disease Rating Scale (UHDRS)
Description
.This scale has 31 items with 5-point ordinal scale ranging rom 0-4 with the highest score indicating inability to perform the motor task
Time Frame
Baseline,week4
Title
Change in Cognitive function as assessed by the Unified Huntington Disease Rating Scale (UHDRS)
Description
.This scale has 3 items with higher scores indicating better cognitive performance
Time Frame
Baseline,week4
Title
Change in behavioral assessment as assessed by the Unified Huntington Disease Rating Scale (UHDRS)
Description
This scale has 10 items with a 5-point ordinal scale ranging form 0-4 with the highest score indicating severe behavioral symptoms.
Time Frame
Baseline,week4
Title
Change in apathy as assessed by the Brief Dimensional Apathy Scale (bDAS)
Description
This scale consists of 9 questions each one scored from 0(almost always) to 3(hardly ever), higher scores indicate more apathy
Time Frame
Baseline, week 2, week 4, week 8
Title
Change in depression as assessed by the Patient Health Questionnaire (PHQ-9)
Description
This questionnaire has 9 questions and each is scored form 0(not at all)-3(nearly every day) with a total score of 27, a higher number indicating more depression.
Time Frame
Baseline, week 2, week 4, week 8
Title
Change in irritability as assessed by the Irritability Questionnaire
Description
This is a 21 item questionnaire and each item is scored form 0(never)-3(most of the time) for a maximum score of 63, a higher number indicating more irritability
Time Frame
Baseline, week 2, week 4, week 8
Title
Change in cognition as assessed by the Montreal Cognitive Assessment (MoCA),
Description
This is scored from 0-30 with higher scores indicating better performance
Time Frame
Baseline, week 2, week 4, week 8
Title
Change in Anxiety and depressive symptoms will assessed using the Hospital Anxiety and Depression Scale (HADS).
Description
HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score greater than 8 denotes anxiety or depression.
Time Frame
Baseline, week 2, week 4, week 8
Title
Change in behavioral symptoms as assessed by the Problem Behaviours Assessment (PBA-s)
Description
Each symptom is rated for severity on a 5-point scale : 0 = "not at all"; 1 = trivial; 2 = mild; 3 = moderate (disrupting everyday activities) and 4 = severe or intolerable. Each symptom is also scored for frequency on a 5-point scale as follows: 0 = symptom absent; 1 = less than once weekly; 2 = at least once a week; 3 = most days (up to and including some part of everyday); and 4 = all day, every day. Severity and frequency scores are multiplied to produce an overall 'PBA score' for each symptom.
Time Frame
Baseline, 2 weeks of treatment, at the end of treatment (week 4) and 4 weeks post-treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Participant:
Inclusion Criteria:
confirmed HD mutation carriers
early (stages 1 and 2) or moderate (stage 3) stages according to Shoulson-Fahn
exhibit mild to moderate behavioral symptoms, such as clinically diagnosed apathy, irritability, anxiety, depression, aggression and repetition
stable doses of medications for at least one month
Exclusion Criteria:
unstable medical conditions
history of epilepsy
metallic objects in the brain
clinical diagnosis of major cognitive disorder or dementia
Have risk of suicidal behavior, defined as any suicidal behavior or suicidal ideation of type 4
Caregiver:
Inclusion Criteria:
-willingness to participate in the study
Exclusion Criteria:
-motor/cognitive symptoms related to Alzheimer's disease or Huntington's disease that might impair the ability to assist the participant during the research study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio L Teixeira Jr, MD,PhD,MSc
Phone
713-486-2555
Email
Antonio.L.Teixeira@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lijin Jose
Phone
713-486-2700
Email
Lijin.Jose@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio L Teixeira Jr, MD,PhD,MSc
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio L Teixeira Jr, MD,PhD,MSc
Phone
713-486-2555
Email
Antonio.L.Teixeira@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Lijin Jose
Phone
713-486-2700
Email
Lijin.Jose@uth.tmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Home-based Transcranial Direct Current Stimulation Open Trial for Behavioral and Cognitive Symptoms in Huntington's Disease
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