Home-based TDCS (Transcranial Direct Current Stimulation) for Cognitive and Behavioral Symptoms in Huntington's Disease

Официальное название

Home-based TDCS for Cognitive and Behavioral Symptoms in Huntington's Disease: a Pilot Feasibility and Mechanistic Study

Обзор

The researchers hope to find out effects of transcranial direct current stimulation (tDCS) sessions on the behavioral symptoms of Huntington's Disease. If participants are eligible to continue, they will be provided a device to administer the tDCS for 30 minutes each day and be asked to answer questions with the study staff . Participants will be asked to return to the study center for follow ups and to undergo additional cognitive tests and questionnaires. Participants will also be asked to answer questionnaires via a web conferencing platform (Zoom) during the course of the study. Caregivers of the participants will be asked to answer questionnaires to collect more information about the participants.

Подробное описание

This clinical trial will investigate the effects of transcranial direct current stimulation (tDCS) over cognitive and behavioral symptoms of patients with Huntington's disease (HD). The study will also investigate underlying neurobiological mechanisms of tDCS in HD.

Вмешательства

• Устройство Transcranial direct current stimulation (tDCS)
  The active-tDCS treatment will consist of a constant 2mA current applied during daily 30-minute sessions with a 30 second ramp up and ramp down at the start and end of the stimulation. The anode electrode will be placed over the left dorsolateral prefrontal cortex (DLPFC) and the cathode electrode over the right DLPFC.
• Устройство Sham tDCS
  Sham-tDCS treatment will consist of the same montage as the active TDCS with the built-in function of the device that has been shown to be indistinguishable from the active treatment in previous trials described in the literature.

Первичные конечные точки

• Percentage of Participants that met Inclusion Criteria [Срок оценки: Baseline]
• Percentage of Participants that Agreed to Randomization [Срок оценки: Baseline]
• Completed period 1 of study [Срок оценки: Day 13]
• Completed period 2 of study [Срок оценки: Day 35]
• Completion of study to last visit [Срок оценки: Day 36 (or day 37)]
• TDCS Acceptability Scale [Срок оценки: Day 14 and Day 35]
• tDCS Side Effects Scale [Срок оценки: Day 8, 14, 29 and 35]

Вторичные конечные точки (2)

• Problem Behaviors Assessment Scale (PBA-S) [Срок оценки: Baseline, and days 14, 22, and 35.]
• Frontal Assessment Battery (FAB) [Срок оценки: Baseline, and days 14 and 35.]

Критерии участия

Критерии включения

• individuals aged 18-85 years with confirmed HD mutation 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 criteria, also known as the UHDRS total functional capacity (TFC) scale (Bates, Tabrizi, and Jones 2014);
• 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.
• Ability of subject to understand and the willingness to sign a written informed consent document.
• Have a caregiver willing to be present during tDCS sessions and answer questionnaires.

Caregiver

• An adult who serves as an unpaid caregiver for an individual enrolled in the study as interpreted by the PI or delegate physician.
• Adequate cognitive capacity to provide verbal consent to participate in the caregiver arm of the study.
• Adequate reading, writing, hearing, and verbal capacity to provide collateral information about the study participant as well as answer questions related to their health and care.

Критерии исключения

• Unstable medical conditions (e.g. unstable angina, uncontrolled diabetes and hypertension, advanced cancer, etc.);
• History of epilepsy;
• Clinical diagnosis of major cognitive disorder (i.e., dementia);
• Have risk of suicidal behavior, defined as any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the 3 months prior to screening (Posner et al. 2011);
• Being an active participant in other therapeutic clinical trial;
• Determined to be incapable of consent per PMH or via assessment by the study staff at time of consent.
• Participant has a pacemaker or any other implanted device/material contraindicated in the use of tDCS per current labeling requirements.

Caregiver

1\. Any individual who does not meet all the inclusion criteria

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Оценка устройства

Центры проведения

США · 1 центр

• University of Texas Health Science Center at San Antonio — San Antonio

Идентификаторы

NCT: NCT06843252 · STUDY00000882

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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