Safety and Tolerability of Patterned Stimulation for DBS in the Home Setting

Обзор

The primary objective of the proposed pilot study is to assess the safety and tolerability of active patterned Deep Brain Stimulation (pDBS) when administered in a home setting for patients with Parkinson's disease (PD) who have had stable bilateral Subthalamic Nucleus (STN) and Globus Pallidus internus (GPi) DBS.

Подробное описание

This pilot study will investigate the safety, tolerability, and feasibility of three distinct patterned Deep Brain Stimulation (pDBS) paradigms delivered in a home setting using the Boston Scientific Chronos Research Engine. The three stimulation patterns under evaluation are:

1. Biphasic DBS (bDBS) 2. Nocturnal Theta Burst Stimulation (tDBS) 3. Region-Specific Frequency Alternation (fDBS).

Sixty patients with Parkinson's Disease (PD), each with stable bilateral Subthalamic Nucleus (STN) and Globus Pallidus internus (GPi) DBS for at least six months, will be enrolled and assigned to one of the three parallel study arms. At the baseline visit, each participant will be programmed with two stimulation settings: one replicating their chronic best clinical setting, and a second incorporating the assigned patterned stimulation.

For participants in the bDBS arm, the second setting will mirror their clinical setting but use a biphasic waveform to ensure charge balancing. In the tDBS arm, the second setting will deliver theta burst stimulation-six bursts per second at the therapeutic frequency-during nighttime hours, using the internal IPG clock to align with the participant's typical sleep schedule. For those in the fDBS arm, the second setting will apply high-frequency stimulation to dorsal contacts (Levels 3 or 4) and low-frequency stimulation (30-60 Hz) to ventral contacts (Levels 1 or 2), while maintaining all other clinical parameters.

Participants will be blinded to the identity of the two settings and will be able to switch between them using their patient programmer. The study will follow a randomized, blinded, two-period crossover design over a total duration of four weeks. During the first two weeks, participants will use one of the two programmed settings. At the end of this period, a telemedicine visit will be conducted to collect quality of life (QoL) questionnaires, related surveys, and a video-based modified MDS-UPDRS assessment. Participants will then switch to the alternate setting for the remaining two weeks. At the conclusion of the study, participants will return for an in-person research visit to complete the same assessments for the second setting. This design allows for within-subject comparison of conventional DBS and patterned DBS in a real-world, home-based environment, and will generate critical data to inform the design of a future large-scale trial.

Вмешательства

• Устройство Biphasic deep brain stimulation
  Deep brain stimulation using active recharge biphasic waveforms consisting of an equal anodic and cathodic pulse immediately delivered sequentially
• Устройство Conventional deep brain stimulation
  Conventional deep brain stimulation programming that is currently FDA approved
• Устройство Theta burst deep brain stimulation
  Deep brain stimulation using a conventional waveform but timed such that in the evening hours (based on device clock) the device will adjust stimulation to bursts of conventional stimulation at 6 per second
• Устройство Multi frequency deep brain stimulation
  Deep brain stimulation using conventional waveforms but simultaneously delivering high frequency stimulation on the dorsal contacts of the DBS lead and low frequency stimulation on the ventral contacts of the DBS lead

Первичные конечные точки

• Tolerability of patterned DBS [Срок оценки: From enrollment to the end of novel waveform trial period at 2 weeks]

Вторичные конечные точки (2)

• Change in motor symptom severity [Срок оценки: From enrollment to the end of study period at 4 weeks]
• Change in quality of life [Срок оценки: From enrollment to the end of the study period at 4 weeks]

Критерии участия

Критерии включения

• Bilateral STN or GPi DBS with Boston Scientific Vercise Genus DBS System
• Diagnosis of Parkinson's disease as confirmed by a movement disorders fellowship trained neurologist
• Chronic stable DBS therapy, defined as having DBS therapy for at least 6 months

Критерии исключения

• History of previous neurosurgical intervention aside from DBS
• Diagnosis of dementia (whether primary or related to Parkinson's disease)
• A diagnosis of atypical parkinsonism or secondary parkinsonism at any time after DBS implantation

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• University of Florida — Gainesville

Публикации

• Horn MA, Gulberti A, Gulke E, Buhmann C, Gerloff C, Moll CKE, Hamel W, Volkmann J, Potter-Nerger M. A New Stimulation Mode for Deep Brain Stimulation in Parkinson's Disease: Theta Burst Stimulation. Mov Disord. 2020 Aug;35(8):1471-1475. doi: 10.1002/mds.28083. Epub 2020 May 1. PMID 32357269
• Wong JK, Hu W, Barmore R, Lopes J, Moore K, Legacy J, Tahafchi P, Jackson Z, Judy JW, Raike RS, Wang A, Tsuboi T, Okun MS, Almeida L. Safety and Tolerability of Burst-Cycling Deep Brain Stimulation for Freezing of Gait in Parkinson's Disease. Front Hum Neurosci. 2021 Apr 26;15:651168. doi: 10.3389/fnhum.2021.651168. eCollection 2021. PMID 33981207
• Akbar U, Raike RS, Hack N, Hess CW, Skinner J, Martinez-Ramirez D, DeJesus S, Okun MS. Randomized, Blinded Pilot Testing of Nonconventional Stimulation Patterns and Shapes in Parkinson's Disease and Essential Tremor: Evidence for Further Evaluating Narrow and Biphasic Pulses. Neuromodulation. 2016 Jun;19(4):343-56. doi: 10.1111/ner.12397. Epub 2016 Mar 22. PMID 27000764

Идентификаторы

NCT: NCT07410598 · IRB202501673

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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