Home-based Transcranial Direct Current Stimulation Open Trial for Behavioral and Cognitive Symptoms in Huntington's Disease

Study Overview
=================
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

Official Title
-----------------
Home-based Transcranial Direct Current Stimulation Open Trial for Behavioral and Cognitive Symptoms in Huntington's Disease

Conditions
-----------------
Huntington Disease

Intervention / Treatment
-----------------
* Device: active tDCS


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active tDCS<br> | Device: active tDCS<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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), retention,and attrition rates | through study completion, an average of 8 weeks | 
| 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. | Baseline, week 2, week 4, week 8 | 
| 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 | week 2, week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline,week4 | 
| 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 | Baseline,week4 | 
| 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. | Baseline,week4 | 
| 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 | Baseline, week 2, week 4, week 8 | 
| 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. | Baseline, week 2, week 4, week 8 | 
| 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 | Baseline, week 2, week 4, week 8 | 
| Change in cognition as assessed by the Montreal Cognitive Assessment (MoCA), | This is scored from 0-30 with higher scores indicating better performance | Baseline, week 2, week 4, week 8 | 
| 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. | Baseline, week 2, week 4, week 8 | 
| 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. | Baseline, 2 weeks of treatment, at the end of treatment (week 4) and 4 weeks post-treatment. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transcranial direct current stimulation