STIMPulseControl Ancillary Speech Study
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: bilateral high frequency deep brain stimulation of the subthalamic neucleus combined with best medical treatment according to widely accepted expert consensus paper, best medical treatment for management of impulse control in Parkinson´s disease according to widely accepted expert consensus paper.
- Кому может быть актуально
- Состояния в реестре: Parkinson Disease, Impulse Control Disorder. Базовые параметры: 18 лет — 70 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
- Германия, Нидерланды, Швейцария
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Speech assessment is a substudy to the STIMPulseControl study (hereinafter referred to as the main study), where audio recordings of patients voices will be recorded as part of a speech analysis in the main study, for this optional ancillary study.
Подробное описание
Speech of all study patients enrolled in the STIMPulseControl main study will be recorded at three points of time in a standardized way. Following this ancillary protocol, patients speech will be recorded at the baseline visit (preoperatively), at the 6-months visit and at the 12-months visit postoperatively.
For the baseline speech assessment the same protocol will be performed in chronic medication conditions. At 12-month follow up, we will repeat the speech protocol in chronic medication and stimulation condition. The recordings will be done in each centre in a decentralized way and the audio files will be produced according to a standardized protocol, and assisted by a step-by-step guided speech recording software.
Main aims and hypothesis for automated speech analysis study are safety measures for surgical interventions in PD assessment of parkinsonian (hypokinetic) motor speech features outcome after STN-DBS, assessment of dyskinetic (hyperkinetic) motor speech features outcome after STN-DBS, assessment of capsular speech features outcome after STN-DBS in PD emotional and cognitive speech outcomes to be used in surgical and pharmacological interventions in PD assessment of acoustic and linguistic speech features as proxy for behaviour and cognitive changes in PD, comparison of emotional and cognitive speech outcomes before and 1-year after STN-DBS + BMT vs BMT alone.
Вмешательства
- Процедура bilateral high frequency deep brain stimulation of the subthalamic neucleus combined with best medical treatment according to widely accepted expert consensus paper
Best medical treatment according to widely accepted expert consensus Paper - Препарат best medical treatment for management of impulse control in Parkinson´s disease according to widely accepted expert consensus paper
Best medical treatment according to widely accepted consensus Paper
Первичные конечные точки
- Titel: PART 1: Assessment of parkinsonian motor speech features (hypokinetic dysarthria) outcome after STN-DBS [Срок оценки: 12 months]
- Titel PART 2: Assessment of acoustic and linguistic speech features as proxy for behavior and cognitive changes in PD [Срок оценки: 12 months]
- Titel PART 2: Assessment of acoustic and linguistic speech features as proxy for behavior and cognitive changes in PD [Срок оценки: 12 months]
Вторичные конечные точки (4)
- PART I/B: Safety measures for surgical interventions in PD [Срок оценки: 12 months]
- PART I/B: Safety measures for surgical interventions in PD [Срок оценки: 12 months]
- PART II/C: Emotional and cognitive speech outcomes to be used in surgical and pharmacological interventions in PD [Срок оценки: 12 months]
- PART I/A: Safety measures for surgical interventions in PD [Срок оценки: 12 months]
Критерии участия
Критерии включения
Please refer to main study (STIMPulseControl KKS-313)
Критерии исключения
Please refer to main study (STIMPulseControl KKS-313)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
Германия · 9 центров
- University Hospital Cologne — Cologne
- University Hospital Carl Gustav Carus — Dresden
- University Hospital Duesseldorf — Düsseldorf
- University Medical Center Hamburg-Eppendorf — Hamburg
- University Hospital Schleswig-Holstein (UKSH), Campus Kiel — Kiel
- University Hospital of Giessen and Marburg (UKGM), Campus Marburg — Marburg
- Charité Campus Mitte — Mitte
- University Hospital Tuebingen — Tübingen
- … и ещё 1 центр
Швейцария · 2 центра
- University Hospital of Bern (Inselspital) — Bern
- University Hospital Zuerich (USZ) — Zurich
Нидерланды · 1 центр
- Amsterdam University Medical Center — Amsterdam
Идентификаторы
NCT: NCT06561919 · KKS-313-A