Combined STN and NBM Deep Brain Stimulation for Mild Cognitive Impairment in Parkinson's Disease

Официальное название

Neurostimulation of the Nucleus Basalis of Meynert for the Cognitive-Motor Syndrome in Parkinson's Disease

Обзор

The goal of this clinical trial is to evaluate the safety and tolerability of a novel deep brain stimulation (DBS) of the Subthalamic Nucleus (STN) and Nucleus Basalis of Meynert (NBM) to treat cognitive and cognitive-motor symptoms in individuals with Parkinson's disease. The main question it aims to answer is: Is a combined deep brain stimulation approach targeting the STN and NBM with four DBS leads safe and tolerable for cognitive and cognitive-motor symptoms in individuals with Parkinson's disease with Mild Cognitive Impairment. Ten participants are anticipated to be enrolled. Participants will undergo a modification of the traditional STN DBS approach for motor symptoms of PD. In addition to the two leads placed within the STN, two additional leads will be placed with the NBM for treatment of cognitive and cognitive-motor symptoms. Novel stimulation patterns will be used within the NBM to target cognitive and cognitive-motor symptoms using an investigational software. Participants will be followed over two years while receiving this therapy with assessments at baseline and every six months. Assessments will include a combination of neuropsychological evaluations, cognitive assessments, motor tasks (including gait/walking), and questionnaires to evaluate the treatment. Two different surgical trajectories will be used, with half the cohort randomized to each group. This will allow comparison of the impact of surgical trajectory on the intervention.

Вмешательства

• Устройство Combined STN+NBM DBS
  This intervention is a 4-lead deep brain stimulation approach targeting the Subthalamic Nucleus (STN) and Nucleus Basalis of Meynert (NBM)

Первичные конечные точки

• Adverse Events [Срок оценки: From baseline to 1 year into treatment]
• Swing Time Coefficient of Variation [Срок оценки: From baseline to 1 year into treatment]

Вторичные конечные точки (12)

• Percent Time Freezing [Срок оценки: From baseline to 1 year into treatment]
• Stride Time Coefficient of Variation [Срок оценки: From baseline to 1 year into treatment]
• Shank Angular Velocity [Срок оценки: From baseline to 1 year into treatment]
• Tapping Speed [Срок оценки: From baseline to 1 year into treatment]
• Tapping Rhythmicity [Срок оценки: From baseline to 1 year into treatment]
• MDS-UPDRS III Score [Срок оценки: From baseline to 1 year into treatment]
• SAT Score [Срок оценки: From baseline to 1 year into treatment]
• Percent False Positives [Срок оценки: From baseline to 1 year into treatment]
• Percent Misses [Срок оценки: From baseline to 1 year into treatment]
• Average + standard deviation of response time [Срок оценки: From baseline to 1 year into treatment]
• Goal-directed focus of attention [Срок оценки: From baseline to 1 year into treatment]
• Sustained attention [Срок оценки: From baseline to 1 year into treatment]

Критерии участия

Критерии включения

• Diagnosis of Parkinson's disease (PD)
• Approved (or planning on) for subthalamic nucleus (STN) deep brain stimulation (DBS)
• Willingness to withdraw from clinical medication regimen when necessary for research visits
• Ability to provide informed consent

Критерии исключения

• Dementia
• Unstable medical, psychiatric conditions including significant untreated depression, history of suicidal attempt, or current suicide ideation
• History of seizures
• Pregnant
• Requires MRI
• Unable to walk 100 feet without an assistive device

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

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Stanford Neuroscience Health Center — Stanford

Идентификаторы

NCT: NCT05968703 · 70608 · UG3NS128150 · UH3NS128150

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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