Home-based Transcranial Direct Current Stimulation Open Trial for Behavioral and Cognitive Symptoms in Huntington's Disease
- Conditions
- Huntington Disease
- Interventions
- Device: active tDCS
- Registration Number
- NCT05326451
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description active tDCS active tDCS -
- Primary Outcome Measures
Name Time Method Feasibility as assessed by the number of participants included and who successfully completed the protocol through study completion, an average of 8 weeks Change in safety of home-based tDCS treatment as as assessed by the tDCS side effect questionnaire week 2, week 4 Safety will be assessed with a 10-item questionnaire about side effects, including itching, burning, headache, fatigue, and dizziness. Each question is scored form 0-10, with a total score range of 0-10 and a higher score indicating more side effects.
Change in acceptability of the treatment as assessed by the tDCS acceptability questionnaire Baseline, week 2, week 4, week 8 Acceptability will be evaluated using a Likert scale (from 0 \[strongly disagree\] to 10 \[strongly agree\]) to answer ten affirmatives regarding the use of home based tDCS, with a total score range of 0-10 and a higher score indicating higher acceptability.
- Secondary Outcome Measures
Name Time Method Change in Cognitive function as assessed by the Unified Huntington Disease Rating Scale (UHDRS) Baseline,week4 The cognitive function section of the UHDRS consists of 5 items rated on a 5-point ordinal scale ranging from 0- to 4, with a total score range of 0 to 20 and with a higher score indicating better cognitive performance.
Change in Behavior as assessed by the Unified Huntington Disease Rating Scale (UHDRS) Baseline,week4 The behavioral section of the UHDRS consists of 11 items evaluating various behavioral signs and symptoms. Individuals are ranked on both severity and frequency on a 0 to 4 scale, with 0 being not present and 4 being severe and frequent. Total behavioral scores are calculated by summing the severity and frequency items, with a total score range of 0 (no behavioral symptoms) to 88 (most severe behavioral symptoms).
Change in Motor function as assessed by the Unified Huntington Disease Rating Scale (UHDRS) Baseline,week4 The motor section of the UHDRS consists of 31 items rated on a 5-point ordinal scale ranging from 0 to 4, with a score of 0 indicating no abnormalities and 4 indicating the most severe impairment. Total score range is 0 to 124, with a higher score indicating decreased inability to perform motor tasks.
Change in depression as assessed by the Patient Health Questionnaire (PHQ-9) Baseline, week 2, week 4, week 8 This questionnaire has 9 questions. with each scored form 0 (not at all) to 3 (nearly every day), with a total score range of 0 to 27 and a higher score indicating more depression.
Change in behavioral symptoms as assessed by the Problem Behaviours Assessment (PBA-s) Baseline, 2 weeks of treatment, at the end of treatment (week 4) and 4 weeks post-treatment. 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.
Change in apathy as assessed by the Brief Dimensional Apathy Scale (bDAS) Baseline, week 2, week 4, week 8 This scale consists of 9 questions, each scored from 0 (almost always) to 3 (hardly ever), with a total score range of 0 to 27 and a higher score indicating more apathy.
Change in cognition as assessed by the Montreal Cognitive Assessment (MoCA) Baseline, week 2, week 4, week 8 MoCA is scored from 0 to 30, with a higher score indicating better performance.
Change in irritability as assessed by the Irritability Questionnaire Baseline, week 2, week 4, week 8 This is a 21-item questionnaire, with each item scored form 0 (never) to 3 (most of the time), for a total score range of of 0 to 63 and a higher score indicating more irritability.
Change in anxiety and depressive symptoms as assessed by the Hospital Anxiety and Depression Scale (HADS) Baseline, week 2, week 4, week 8 HADS is a 14-item scale, with seven items each for anxiety and depression subscales. Scoring for each item ranges from 0 to 3, with a total score range of 0 to 42 and a total subscale score range of 0 to 21. A subscale score greater than 8 denotes anxiety or depression.
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States