Investigating the Increased Risk of Falls in Individuals With Parkinson's Disease Treated With Deep Brain Stimulation
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: DBS as part of standard of care.
- Кому может быть актуально
- Состояния в реестре: Deep Brain Stimulation, PARKINSON DISEASE (Disorder). Базовые параметры: 30 лет — 80 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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Обзор
The purpose of this pilot study is to assess changes in thinking and movement after deep brain stimulator implantation. The study will also examine whether these changes are related to the risk of falls.
Подробное описание
Deep brain stimulation (DBS) is an effective 2nd line therapeutic strategy for Parkinson's disease (PD) patients in whom pharmacologic interventions no longer optimally control primary motor symptoms such as rigidity, bradykinesia, and tremor. However, the extent to which DBS improves axial motor symptoms (e.g., postural instability) is equivocal. While some investigations show improved static and dynamic balance measured in the lab, many studies also show that individuals fall at a higher rate compared to those without DBS. Increased incidence of falls reduce participation in the community. Thus, it is important to identify modifiable mechanisms of falls and design interventions that address these factors. However, in many studies investigating balance in PD, DBS is an exclusionary factor. This study addresses a major unmet need in PD therapeutics to identify causal factors that increase fall risk after DBS implantation and programming.
Вмешательства
- Поведенческое DBS as part of standard of care
Individuals with Parkinson's Disease will be selected to undergo DBS as part of standard of care. Those individuals will be assessed prior to and 3 months after.
Первичные конечные точки
- Self-Reported Falls [Срок оценки: From enrollment to end of study will be 4-5 months]
Вторичные конечные точки (1)
- Step count [Срок оценки: From enrollment to end of participation will be about 4-5 months]
Критерии участия
Критерии включения
- Age between 30-80, patient has elected to undergo DBS surgery as part of routine care, cleared for deep brain stimulation surgery as part of routine care by the movement disorders committee. Refractory motor symptoms such as dyskinesias, wearing off, and/or motor fluctuations, causing significant disability, despite reasonable attempts at medical management, as determined by the consensus DBS committee, able to walk, Patient is available for follow-up over the length of the study
Exclusion Criteria: Patient's insurance will not cover the costs of surgery with investigational devices, Medical contraindications such as current uncontrolled hypertension, heart disease, coagulopathy, or other conditions contraindicating DBS surgery or stimulation, self-report of lack of clear levodopa response, requires a walker or wheelchair for mobility
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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
- Диагностика
Центры проведения
США · 1 центр
- UAB WHARF at Lakeshore — Homewood
Идентификаторы
NCT: NCT07725315 · IRB-300016843 · UAB CEDHARS