Deep Brain Stimulation (DBS) of the Pedunculopontine Nucleus (PPN)

Официальное название

Effects of Deep Brain Stimulation (DBS) of the Pedunculopontine Nucleus (PPN) on Gait, Postural Stability, Freezing of Gait (FOG), and Falls

Обзор

This is a mechanistic study to determine the differential effects of the dopaminergic and cholinergic systems on attention, gait, and balance. The primary goal of the study is to evaluate the relative effects of pedunculopontine nucleus (PPN) and subthalamic nucleus (STN) Deep Brain Stimulation (DBS) on these features in persons with Parkinson's Disease (PD) who are eligible for DBS for improvement of their motor symptoms and exhibit gait instability with falls. Patients will be enrolled and implanted with bilateral electrodes in one of the approved DBS locations (subthalamic nucleus: STN), but additionally electrodes will be inserted into the experimental target, namely the PPN bilaterally.

Подробное описание

This is a prospective, single-center randomized controlled trial designed to estimate the potential clinical benefit, and associated risks, of deep brain stimulation of the of the PPN and STN in patients with PD that are candidates for DBS for improvement of their motor symptoms and exhibit gait instability with falls. Patients will be enrolled and implanted with additional bilateral electrodes in the PPN. Each subject will be randomized 1:1 to one of the following sequences: Bilateral STN+PPN stimulation or Bilateral STN stimulation alone. The addition of a bilateral STN stimulation only group allows for the research of potential micro-lesioning effects of the PPN which might affect features of interest even in the absence of PPN stimulation.

Вмешательства

• Устройство STN-PPN DBS Surgery
  Subject will undergo standard bilateral STN DBS surgery and have 2 additional leads placed in the same burr with bilateral PPN targets
• Процедура Deep Brain Stimulation Surgery (DBS)
  DBS lead implantation of bilateral STN

Первичные конечные точки

• STN-PPN Stimulation Effect on Fall Risk [Срок оценки: 27 months]

Вторичные конечные точки (7)

• STN-PPN on Linear and Nonlinear Measures of Gait [Срок оценки: 27 months]
• STN-PPN on Linear and Nonlinear Measures of Balance [Срок оценки: 27 months]
• STN-PPN on Attention [Срок оценки: 27 months]
• STN-PPN on Subjective Measures of Alertness [Срок оценки: 27 months]
• STN-PPN on Subjective Measures of Sleep [Срок оценки: 27 months]
• STN-PPN on Subjective Measures of Non-Motor Symptoms [Срок оценки: 27 months]
• STN-PPN on Subjective Measures of Balance in Daily Life [Срок оценки: 27 months]

Критерии участия

Критерии включения

• Inclusion Criteria

• Informed consent signed by the subject.
• Diagnosed with Parkinson's disease per UK Parkinson's Disease Society Brain Bank (Queens Square) criteria for at least 4 years
• Demonstrates levodopa responsiveness of at least 30%
• Experiences tremor or motor complications including wearing off and/or dyskinesia
• DBS candidate per FDA guidelines as outlined in criteria 2-4
• Candidate for STN targeting per the consensus committee
• Subject exhibits gait instability, or a history of at least one fall within the last year, or a history of falls on tests of Static or Dynamic Stability.
• PD Stage 2-3 with predominant axial symptoms or FOG refractory to Levodopa > 600 mg and UPDRS Part III Subscore of >6.
• Subject is ambulatory and able to walk for limited periods of time without using an assistive device.
• 18-75 years of age
• Primary English speaking
• Physically and cognitively capable of completing evaluations and consent
• Medically cleared for surgery and anesthesia
• Female subjects with child-bearing potential have a negative serum pregnancy test prior to DBS surgery

Критерии исключения

Критерии исключения

• Dementia per DSM-V criteria
• Condition precluding MRI
• History of supraspinal CNS disease other than PD
• History of schizophrenia, delusions, or currently uncontrolled visual hallucinations
• Subjects who require rTMS, ECT, diathermy, or repeat MRI procedures to treat a medical condition.
• Subjects with a history of seizure disorder
• Subjects who have made a suicide attempt within the prior year,
• Subjects with any medical contraindications to undergoing DBS surgery (eg, infection, coagulopathy, or significant cardiac or other medical risk factors for surgery)
• Subjects with an implanted stimulator such as a cardiac pacemaker, defibrillator, neurostimulator and cochlear implant
• Subjects who are pregnant or nursing.
• Patient that is unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
• Any other reasons that, in the opinion of the investigator, the candidate is determined to be unsuitable for entry into the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• St. Joseph's Hospital & Medical Center / Barrow Neurological Institute — Phoenix

Идентификаторы

NCT: NCT04605263 · PHX-19-500-412-30-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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