Идёт набор NCT07430761

ET Stigma Response to Tremor Suppression

— Наблюдательное Action Tremor Stigma, Social

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: stereotactic thalamotomy with focused ultrasound.
Кому может быть актуально: Состояния в реестре: Action Tremor, Stigma, Social. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

ET Stigma Response to Tremor Suppression With Focused Ultrasound Thalamotomy

Обзор

Essential Tremor (ET) is prevalent, affecting approximately 3% of the adult population. Involuntary shaking of the hands during action is a prominent feature, interfering with feeding and writing and other manual tasks. The involuntary movement is visible to observers, some of whom misinterpret the shakiness as manifestation of anxiety or instability, while some other observers attribute it to alcohol or drug use. The psychological effects of resulting stigma on quality of life for people with ET can rival the physical difficulties caused by the condition. For this study, we propose to measure 1 year after effective tremor suppression following thalamotomy with high intensity focused ultrasound changes from baseline in psychological distress and social dysfunction related to ET stigma, and to correlate change from baseline with improvement in functional status related to tremor and in objective measures of tremor severity. We hope to discover that ET stigma is largely reversible when tremor is effectively treated, and we aim to learn what degree of tremor suppression correlates with substantial psychological relief. We will also determine if ET stigma is predominantly helped by unilateral dominant-hand treatment, or if the second side treatment is necessary to accomplish most benefit.

Подробное описание

Study procedures:

Subjects will complete the following three surveys on two occasions i.e. at baseline, hours or days before thalamotomy, and again 12 months after the procedure (with a window of 11 to 18 months). Completing the three surveys takes approximately 5 minutes.

1. The ET-stigma distress scale which has 11 items each with 5 response options ranging from "strongly disagree" to "strongly agree" 2. the ET stigma dysfunction scale which has 5 items each with 3 response options ranging from "not at all or rarely" to "frequently" 3. the Tremor Disability Scale-Revised with 20 items each with 4 response options ranging from "no difficulty" to "cannot perform the task".

Вмешательства

Процедура stereotactic thalamotomy with focused ultrasound
stereotactic thalamotomy with high intensity focused ultrasound, guided by four-tract tractography

Первичные конечные точки

ET stigma psychological distress [Срок оценки: change from baseline before thalamotomy to 12 months after thalamotomy]
ET stigma social dysfunction [Срок оценки: change from baseline before thalamotomy to 12 months after thalamotomy]

Критерии участия

Критерии включения

People with ET as diagnosed by a movement disorder neurologist
Tremor of sufficient severity and impact on quality of life so as to justify a lesional brain procedure
Competent to consent to undergoing high intensity focused ultrasound thalamotomy targeted by 4-tract tractography
Provide verbal informed consent to this study of ET stigma