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Идёт набор NCT05822388

Cognitive Decline Following Deep Brain Stimulation

— Наблюдательное Parkinson Disease Movement Disorders

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: Deep Brain Stimulation Surgical Procedures as Part of Routine Clinical Care.
Кому может быть актуально
Состояния в реестре: Parkinson Disease, Movement Disorders. 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

A Neural Basis for Cognitive Decline Following Deep Brain Stimulation

Обзор

This research study aims to identify MRI-based brain biomarkers that predict an individual's response to Deep Brain Stimulation (DBS). In particular, this study will focus on changes in cognition associated with DBS. A total of 55 participants with Parkinson's Disease planning to undergo DBS will be recruited from MUSCs Clinical DBS Program. Participants will undergo four visits, including a 1-hour screening visit, a 1.5-hour pre-DBS MRI scanning visit, and a 3.5-hour post-DBS cognitive assessment visit. In addition control participants without Parkinson's Disease will be recruited to undergo MRI scanning and cognitive assessments.

Подробное описание

Deep brain stimulation (DBS) targeting the subthalamic nucleus (STN) is a well-established surgical intervention to treat Parkinson's Disease (PD) patients with disabling motor fluctuations and dyskinesias. Although this therapy is effective for motor complications, a subset of patients will go on to experience cognitive decline, which can overshadow improvements in the quality of life provided by STN-DBS. This accelerated decline in cognition occurs in patients despite rigorous evaluation of their neuropsychological status prior to surgery. While the factors contributing to cognitive decline following DBS remain unclear, there is evidence this may be the result of 1) limited cognitive reserve prior to DBS surgery, 2) stimulation that interferes with cognitive networks, and/or 3) a microlesion effect due to placement of the lead. Understanding how these factors contribute to DBS-induced cognitive decline has the potential to improve patient selection for surgery and optimize the selection of stimulation targets that minimize undesirable cognitive side effects.

Вмешательства

  • Процедура Deep Brain Stimulation Surgical Procedures as Part of Routine Clinical Care
    Participants in this study will already be undergoing a DBS intervention, however, this is part of their standard clinical care. Pre-surgical DBS candidates that enroll in this study will consent to participate in 1) pre-operative neuroimaging including a high-resolution MRI scan, 2) collection of pre-operative neurocognitive data via chart review and 3) a 1-year postoperative neurocognitive assessment.

Первичные конечные точки

  • Change in Cognition [Срок оценки: From the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation) until 1 year post surgery]
  • Brain Microstructure (DKI) [Срок оценки: Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))]
Вторичные конечные точки (2)
  • Brain Functional Connectivity [Срок оценки: Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))]
  • Brain Microstructure (DTI) [Срок оценки: Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))]

Критерии участия

PD Participants

Критерии включения

  • Subjects above 18 years of age
  • Subjects who will undergo DBS surgery as part of their clinical care for PD

Критерии исключения

  • Uncorrected visual or hearing impairments, as indicated by self-report
  • Individuals who are pregnant or expect to become pregnant during the course of the study
  • Individuals with claustrophobia, or the inability to lie supine position in the MRI scanner
  • COPD with oxygen dependence
  • Non-MRI compatible metal implants (surgical clips or staples, cardiac pacemakers etc.)

Non-PD Control Participants

Критерии включения

  • Subjects above 18 years of age
  • Age matched to participants in PD group

Критерии исключения

  • Diagnosis of Parkinsons Disease or other movement disorder
  • Untreated neuropsychiatric disorders
  • Uncorrected visual or hearing impairments, as indicated by self-report
  • Individuals who are pregnant or expect to become pregnant during the course of the study
  • Individuals with claustrophobia, or the inability to lie supine position in the MRI scanner
  • COPD with oxygen dependence
  • Non-MRI compatible metal implants (surgical clips or staples, cardiac pacemakers etc.)

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Medical University of South Carolina — Charleston

Идентификаторы

NCT: NCT05822388 · Pro00125181

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗