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

Huntington Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05326451
• Other study ID #: HSC-MS-21-1065
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: January 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: Erin Stimming, MD
• Phone: (713) 500-7033
• Email: Erin.E.Furr[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Huntington Disease
• Neurobehavioral Manifestations

Intervention

Device:
• active tDCS
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as assessed by the number of participants included and who successfully completed the protocol		through study completion, an average of 8 weeks
Primary	Change in acceptability of the treatment as assessed by the tDCS acceptability questionnaire	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.	Baseline, week 2, week 4, week 8
Primary	Change in safety of home-based tDCS treatment as as assessed by the tDCS side effect questionnaire	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.	week 2, week 4
Secondary	Change in Motor function as assessed by the Unified Huntington Disease Rating Scale (UHDRS)	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.	Baseline,week4
Secondary	Change in Cognitive function as assessed by the Unified Huntington Disease Rating Scale (UHDRS)	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.	Baseline,week4
Secondary	Change in Behavior as assessed by the Unified Huntington Disease Rating Scale (UHDRS)	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).	Baseline,week4
Secondary	Change in apathy as assessed by the Brief Dimensional Apathy Scale (bDAS)	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.	Baseline, week 2, week 4, week 8
Secondary	Change in depression as assessed by the Patient Health Questionnaire (PHQ-9)	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.	Baseline, week 2, week 4, week 8
Secondary	Change in irritability as assessed by the Irritability Questionnaire	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.	Baseline, week 2, week 4, week 8
Secondary	Change in cognition as assessed by the Montreal Cognitive Assessment (MoCA)	MoCA is scored from 0 to 30, with a higher score indicating better performance.	Baseline, week 2, week 4, week 8
Secondary	Change in anxiety and depressive symptoms as assessed by the Hospital Anxiety and Depression Scale (HADS)	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.	Baseline, week 2, week 4, week 8
Secondary	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.