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

Обзор

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

Вмешательства

• Устройство 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 fr

Первичные конечные точки

• Feasibility as assessed by the number of participants included and who successfully completed the protocol [Срок оценки: through study completion, an average of 8 weeks]
• Change in acceptability of the treatment as assessed by the tDCS acceptability questionnaire [Срок оценки: Baseline, week 2, week 4, week 8]
• Change in safety of home-based tDCS treatment as as assessed by the tDCS side effect questionnaire [Срок оценки: week 2, week 4]

Вторичные конечные точки (9)

• Change in Motor function as assessed by the Unified Huntington Disease Rating Scale (UHDRS) [Срок оценки: Baseline,week4]
• Change in Cognitive function as assessed by the Unified Huntington Disease Rating Scale (UHDRS) [Срок оценки: Baseline,week4]
• Change in Behavior as assessed by the Unified Huntington Disease Rating Scale (UHDRS) [Срок оценки: Baseline,week4]
• Change in apathy as assessed by the Brief Dimensional Apathy Scale (bDAS) [Срок оценки: Baseline, week 2, week 4, week 8]
• Change in depression as assessed by the Patient Health Questionnaire (PHQ-9) [Срок оценки: Baseline, week 2, week 4, week 8]
• Change in irritability as assessed by the Irritability Questionnaire [Срок оценки: Baseline, week 2, week 4, week 8]
• Change in cognition as assessed by the Montreal Cognitive Assessment (MoCA) [Срок оценки: Baseline, week 2, week 4, week 8]
• Change in anxiety and depressive symptoms as assessed by the Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Baseline, week 2, week 4, week 8]
• Change in behavioral symptoms as assessed by the Problem Behaviours Assessment (PBA-s) [Срок оценки: Baseline, 2 weeks of treatment, at the end of treatment (week 4) and 4 weeks post-treatment.]

Критерии участия

Participant:

Критерии включения

• confirmed HD mutation carriers and/or established family history alongside typical symptoms (i.e. chorea) of HD;
• early (stages 1 and 2) or moderate (stage 3) stages according to Shoulson-Fahn
• exhibit mild to moderate behavioral symptoms defined by severity scores in the PBA-S between 1 and 3 for any of the evaluated symptoms and no symptoms with a severity score of 4
• stable doses of medications for at least one month
• Have a caregiver willing to be present during tDCS sessions and answer questionnaires.

Критерии исключения

• unstable medical conditions
• history of epilepsy
• metallic objects in the brain
• Have a caregiver willing to be present during tDCS sessions and answer questionnaires.
• clinical diagnosis of major cognitive disorder or dementia
• Have risk of suicidal behavior, defined as any suicidal behavior or suicidal ideation of type 4 or type 5 based on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the 3 months prior to screening
• simultaneous participation in other clinical trial
• Individuals determined to be incapable of consent per past medical history or via assessment by the study staff at time of consent.

Caregiver:

Критерии включения

-willingness to participate in the study

Критерии исключения

-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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The University of Texas Health Science Center at Houston — Houston

Идентификаторы

NCT: NCT05326451 · HSC-MS-21-1065

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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