Clinical trial NCT05326451: 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
Overall status: RECRUITING
Phase: NA
Conditions: Huntington Disease
Keywords: transcranial direct current stimulation
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Feasibility as assessed by the number of participants included and who successfully completed the protocol
timeFrame: through study completion, an average of 8 weeks
measure: Change in acceptability of the treatment as assessed by the tDCS acceptability questionnaire
timeFrame: Baseline, week 2, week 4, week 8
measure: Change in safety of home-based tDCS treatment as as assessed by the tDCS side effect questionnaire
timeFrame: week 2, week 4
Secondary outcomes:
measure: Change in Motor function as assessed by the Unified Huntington Disease Rating Scale (UHDRS)
timeFrame: Baseline,week4
measure: Change in Cognitive function as assessed by the Unified Huntington Disease Rating Scale (UHDRS)
timeFrame: Baseline,week4
measure: Change in Behavior as assessed by the Unified Huntington Disease Rating Scale (UHDRS)
timeFrame: Baseline,week4
measure: Change in apathy as assessed by the Brief Dimensional Apathy Scale (bDAS)
timeFrame: Baseline, week 2, week 4, week 8
measure: Change in depression as assessed by the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, week 2, week 4, week 8
measure: Change in irritability as assessed by the Irritability Questionnaire
timeFrame: Baseline, week 2, week 4, week 8
measure: Change in cognition as assessed by the Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, week 2, week 4, week 8
measure: Change in anxiety and depressive symptoms as assessed by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, week 2, week 4, week 8
measure: Change in behavioral symptoms as assessed by the Problem Behaviours Assessment (PBA-s)
timeFrame: Baseline, 2 weeks of treatment, at the end of treatment (week 4) and 4 weeks post-treatment.
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Erin Stimming, MD
role: PRINCIPAL_INVESTIGATOR
References: