Dual Frequency Stimulation in Parkinson's Disease

Официальное название

Dual Frequency, Dual Region Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease

Обзор

Deep brain stimulation (DBS) in the dorsal region of the subthalamic nucleus (STN) is very effective for reducing motor symptoms of Parkinson's disease (PD). Modeling studies suggest that this therapy may result in current spread into the ventral STN, causing altered cognitive processes. As a result, current stimulation parameters often lead to worsening in verbal fluency, executive function, and, particularly, cognitive control. There is evidence suggesting that low frequency oscillatory activity occurs across brain circuits important in integrating information for cognition. Preclinical studies and human recording studies indicate these low frequency theta oscillations drive cognitive control during cognitive tasks. Thus, the purpose of this study is to determine the safety, tolerability, and efficacy of low frequency stimulation (LFS) of the ventral STN alongside standard high frequency stimulation (HFS) of the dorsal STN in patients with PD.

Вмешательства

• Устройство Deep brain stimulation
  Patients with idiopathic Parkinson's disease who have previously been implanted with the Boston Scientific VerciseTM DBS system for at least 3 months. These patients will already be receiving high-frequency dorsal STN stimulation as part of the standard of care for PD. Once patients have provided consent and are enrolled in this study, they will receive simultaneous low-frequency stimulation of the ventral STN to examine if there are any effects on cognitive performance.

Первичные конечные точки

• Mean Change from Baseline in Depression Scores on the Center for Epidemiologic Studies Depression Scale (CES-D) [Срок оценки: Baseline, Week 2, Week 6, Month 3, and Month 6]
• Mean Change from Baseline in Impulsiveness Scores on the Barratt Impulsiveness Scale (BIS-11) [Срок оценки: Baseline, Week 2, Week 6, Month 3, and Month 6]
• Mean Change from Baseline in Neuropsychiatric Inventory (NPI) [Срок оценки: Baseline, Week 2, Week 6, Month 3, and Month 6]
• Mean Change from Baseline in Movement Scores on Part III of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [Срок оценки: Baseline, Week 2, Week 6, Month 3, and Month 6]
• Mean Change from Baseline in Cognitive Performance Scores on the Montreal Cognitive Assessment - Blind (MoCA) [Срок оценки: Baseline, Hour 24, Week 1, Month 1, Month 2, Month 4, and Month 5]
• Mean Change from Baseline in Depression Scores on the CES-D Short Version (CES-D-R10) [Срок оценки: Baseline, Hour 24, Week 1, Month 1, Month 2, Month 4, and Month 5]
• Mean Change from Baseline in Motor and Non-Motor Aspects of Daily Living Scores on Parts I and II of the MDS-UPDRS [Срок оценки: Baseline, Hour 24, Week 1, Month 1, Month 2, Month 4, and Month 5]

Вторичные конечные точки (3)

• Mean Change from Baseline in Decision-Making Scores on Probabilistic Gambling Task [Срок оценки: Baseline, Minute 30, Week 2, Week 6, Month 3, and Month 6]
• Mean Change from Baseline in Inter-Temporal Choice Scores on a Temporal Discounting Task [Срок оценки: Baseline, Minute 30, Week 2, Week 6, Month 3, and Month 6]
• Mean Change from Baseline in Verbal Fluency Scores on Word Generation Task [Срок оценки: Baseline, Minute 30, Week 2, Week 6, Month 3, and Month 6]

Критерии участия

Критерии включения

• Individuals who are 18 years and older
• Individuals with idiopathic Parkinson's Disease who previously underwent implantation with the Boston Scientific VerciseTM DBS system
• Individuals who have been implanted with the Boston Scientific VerciseTM DBS system for at least 3 months
• Individuals diagnosed with advanced PD who had bilateral dorsal subthalamic nucleus DBS surgery, as standard of care for motor improvement, with distal contacts of the electrodes implanted into the ventral STN

Критерии исключения

• Individuals unable to provide consent and/or lack capacity to consent
• Individuals diagnosed with any cognitive or physical impairments that would limit their ability to participate in the cognitive testing
• Individuals who score below 15 on the Montreal Cognitive Assessment Test-Blind
• Individuals who score above 20 on the Center for Epidemiologic Studies Depression Scale
• Pregnant women (note: pregnant women are not candidates for DBS surgery), and prisoners
• Non-English speaking individuals. Cognitive tasks will only be conducted in English.

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

Лечение

Центры проведения

США · 1 центр

• UC Davis Health — Sacramento

Публикации

• Bergman H, Wichmann T, DeLong MR. Reversal of experimental parkinsonism by lesions of the subthalamic nucleus. Science. 1990 Sep 21;249(4975):1436-8. doi: 10.1126/science.2402638. PMID 2402638
• Peters J, D'Esposito M. Effects of Medial Orbitofrontal Cortex Lesions on Self-Control in Intertemporal Choice. Curr Biol. 2016 Oct 10;26(19):2625-2628. doi: 10.1016/j.cub.2016.07.035. Epub 2016 Sep 1. PMID 27593380
• Laxton AW, Lozano AM. Deep brain stimulation for the treatment of Alzheimer disease and dementias. World Neurosurg. 2013 Sep-Oct;80(3-4):S28.e1-8. doi: 10.1016/j.wneu.2012.06.028. Epub 2012 Jun 19. PMID 22722036
• Temperli P, Ghika J, Villemure JG, Burkhard PR, Bogousslavsky J, Vingerhoets FJ. How do parkinsonian signs return after discontinuation of subthalamic DBS? Neurology. 2003 Jan 14;60(1):78-81. doi: 10.1212/wnl.60.1.78. PMID 12525722
• Scangos KW, Carter CS, Gurkoff G, Zhang L, Shahlaie K. A pilot study of subthalamic theta frequency deep brain stimulation for cognitive dysfunction in Parkinson's disease. Brain Stimul. 2018 Mar-Apr;11(2):456-458. doi: 10.1016/j.brs.2017.11.014. Epub 2017 Nov 23. No abstract available. PMID 29203130
• Le Jeune F, Peron J, Grandjean D, Drapier S, Haegelen C, Garin E, Millet B, Verin M. Subthalamic nucleus stimulation affects limbic and associative circuits: a PET study. Eur J Nucl Med Mol Imaging. 2010 Aug;37(8):1512-20. doi: 10.1007/s00259-010-1436-y. Epub 2010 Mar 28. PMID 20349231
• Sharma AK, Reams RY, Jordan WH, Miller MA, Thacker HL, Snyder PW. Mesial temporal lobe epilepsy: pathogenesis, induced rodent models and lesions. Toxicol Pathol. 2007 Dec;35(7):984-99. doi: 10.1080/01926230701748305. PMID 18098044
• Volkmann J. Deep brain stimulation for the treatment of Parkinson's disease. J Clin Neurophysiol. 2004 Jan-Feb;21(1):6-17. doi: 10.1097/00004691-200401000-00003. PMID 15097290

Идентификаторы

NCT: NCT04650932 · 1633883

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗