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Идёт набор NCT06960096

Cognitive Decline Following Deep Brain Stimulation: A DBS-fMRI Study

— Наблюдательное Deep Brain Stimulation Parkinson Disease

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 combined with fMRI.
Кому может быть актуально
Состояния в реестре: Deep Brain Stimulation, Parkinson Disease. 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
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Официальное название

A Neural Basis for Cognitive Decline Following Deep Brain Stimulation: A DBS-fMRI Study

Обзор

The objective of this research study is to understand how Deep Brain Stimulation (DBS) targeting the subthalamic nucleus (STN) affects cognitive networks in the brain, potentially leading to cognitive decline in patients with Parkinson's Disease (PD). A total of 55 participants with PD who have undergone DBS surgery will be recruited from MUSC's Clinical DBS Program. Participants will attend two post-DBS visits: a 3-hour visit for consent, demographic, and cognitive assessments, and a 3-hour DBS-MRI visit to evaluate brain network connectivity with stimulation ON and OFF. These findings will help improve patient selection for surgery and optimize the selection of stimulation targets that minimize undesirable cognitive side effects.

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. This research seeks to identify how DBS-induced changes in neural connectivity contribute to cognitive decline and how brain microstructure influences these changes. Understanding how these factors has the potential to improve patient selection for surgery and optimize the selection of stimulation targets that minimize undesirable cognitive side effects.

Вмешательства

  • Другое DBS combined with fMRI
    Participants will undergo fMRI scanning while their DBS device is either turned OFF or ON. BOLD (blood oxygen level dependent) changes in response to DBS will be evaluated across PD participants. These scans and DBS procedure will be used for research purposes only and are not for treatment or diagnostic purposes.

Первичные конечные точки

  • Change in executive function performance [Срок оценки: Baseline and approximately 1 year (10-14 months) following deep brain stimulation]
Вторичные конечные точки (1)
  • Change in Language and Attention [Срок оценки: Baseline and approximately 1 year (10-14 months) following deep brain stimulation]

Критерии участия

Критерии включения

  • Subjects above 18 years of age
  • Individuals with a PD diagnosis as defined by the UK Brain Bank diagnostic criteria for Parkinson's disease (58) which have undergone a neurological and neuropsychological evaluation at MUSCs movement disorder center, and were selected to undergo 3T compatible unilateral or bilateral STN- DBS implants

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 that have a history of neurological disease (other than PD) including previous stroke, major head trauma, and epilepsy or seizures.
  • 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
Только случаи

Центры проведения

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

Идентификаторы

NCT: NCT06960096 · Pro00142451 · 1K99NS131447-01 · 4R00NS131447-03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗