Набор скоро начнётся NCT07215481

Automated Image-Guided Programming of Deep Brain Stimulation (DBS) for Parkinson's Disease

Без фазы С лечением Parkinson's Disease (PD)

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: Shame Control (Baseline), Standard of Care Deep Brain Stimulation, Illumina 3D Deep Brain Stimulation, Illumina 3D Deep Brain Stimulation Reduced Amplitude.
Кому может быть актуально: Состояния в реестре: Parkinson's Disease (PD). Базовые параметры: от 21 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Quantitative Digitography to Evaluate the Efficacy of Image Guided Algorithmic DBS Programming

Обзор

The goal of this clinical trial is to evaluate an automated deep brain stimulation (DBS) algorithm developed by Boston Scientific called Illumina 3D for motor symptoms in Parkinson's disease (PD). The main question it aims to answer is: Is this new automated algorithm effective for treating motor symptoms of PD. Fifteen participants are anticipated to be enrolled. Participants are individuals who recently were implanted with DBS in the subthalamic nucleus as part of their regular clinical treatment and are scheduled to have their DBS turned ON for the first time. In addition to their regular clinical visit when their DBS is turned ON by their clinician, participants are tested on DBS settings determined by Illumina 3D (an automated algorithm). Participants are tested on these different settings across different motor tasks, including walking and finger tapping, as well as answering questionnaires. The experiment is expected to last 1 or 2 days; this is not a longitudinal or long-term trial. Participants return to their usual DBS settings once they leave the clinic.

Вмешательства

Устройство Shame Control (Baseline)
Participant's device (Boston Scientific Vercise Genus neurostimulator) is turned off for 45 minutes.
Устройство Standard of Care Deep Brain Stimulation
Participant's device (Boston Scientific Vercise Genus neurostimulator) is turned 'ON' for 45 minutes using a configuration and amplitude determined as standard of care by the clinician.
Устройство Illumina 3D Deep Brain Stimulation
Participant's device (Boston Scientific Vercise Genus neurostimulator) is turned 'ON' for 45 minutes using a configuration and amplitude determined by the automated Illumina 3D algorithm.
Устройство Illumina 3D Deep Brain Stimulation Reduced Amplitude
Participant's device (Boston Scientific Vercise Genus neurostimulator) is turned 'ON' for 45 minutes using a configuration and amplitude determined by the automated Illumina 3D algorithm but at a reduced stimulation amplitude.
Устройство Illumina 3D Deep Brain Stimulation Higher Amplitude
Participant's device (Boston Scientific Vercise Genus neurostimulator) is turned 'ON' for 45 minutes using a configuration and amplitude determined by the automated Illumina 3D algorithm but at a higher stimulation amplitude.

Первичные конечные точки

Change in QDG Mobility Score (OFF DBS to Illumina 3D) [Срок оценки: Baseline and after 45 minutes of Illumina 3D DBS]

Вторичные конечные точки (12)

Change in QDG Tremor Severity Score (OFF DBS to Illumina 3D) [Срок оценки: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS]
Change in QDG Percent Rest Tremor (OFF DBS to Illumina 3D) [Срок оценки: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS]
Change in QDG Press Amplitude (OFF DBS to Illumina 3D) [Срок оценки: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS]
Change in QDG Press Amplitude Coefficient of Variation (OFF DBS to Illumina 3D) [Срок оценки: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS]
Change in QDG Interstrike Interval (OFF DBS to Illumina 3D) [Срок оценки: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS]
Change in QDG Release Slope (OFF DBS to Illumina 3D). [Срок оценки: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS]
Change in QDG Press Speed (OFF DBS to Illumina 3D) [Срок оценки: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS]
Change in QDG Interstrike Interval Coefficient of Variation (OFF DBS to Illumina 3D) [Срок оценки: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS]
Change in QDG Percent Freezing (OFF DBS to Illumina 3D) [Срок оценки: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS]
Change in Gait Speed (OFF DBS to Illumina 3D) [Срок оценки: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS]
Change in Gait Arrhythmicity (OFF DBS to Illumina 3D) [Срок оценки: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS]
Change in MDS-UPDRS III Total Score (OFF DBS to Illumina 3D) [Срок оценки: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS]

Критерии участия

Критерии включения

Diagnosis of Parkinson's disease (PD)
Newly implanted or soon to be implanted with deep brain stimulation (Boston Scientific device)
Willingness to withdraw from clinical medication regimen when necessary for research visits