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Идёт набор NCT07348705

Electrophysiology-based DBS Programming for PD

Без фазы С лечением Parkinson's Disease (PD)

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: Clinician-based DBS programming, Maximum Beta power-based DBS programming, Broad-band electrophysiology-based DBS programming.
Кому может быть актуально
Состояния в реестре: Parkinson's Disease (PD). Базовые параметры: 21 лет — 89 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

Electrophysiology-based Deep Brain Stimulation Programming for Parkinson's Disease

Обзор

Deep brain stimulation (DBS) effectively alleviates motor symptoms in Parkinson's disease (PD). However, current programming is manual and time-consuming. This study will evaluate physiology-based programming using local field potentials (LFPs) to identify optimal stimulation parameters. Specifically, DBS contact selection based on beta power and a broad-band approach will be compared with conventional clinician-based programming.

Подробное описание

Up to thirty patients with DBS (unilateral or bilateral leads) attached to a bidirectional implantable pulse generator will be enrolled in this study. This commercially available IPG allows both therapeutic stimulation and chronic sensing. It has been designed to capture local field potentials (LFPs) from implanted DBS leads while delivering stimulation both inside and outside the clinic.

After recording LFP data, then, the physician will perform the traditional clinical monopolar review and determine the optimized DBS settings ('clinician-based' settings) following standard clinical procedures, and without looking at the physiology data. In parallel, the LFP data will be analyzed to identify the 'optimal' therapy contact based on 1) maximum beta power, and 2 ) broad-band multi-frequency analysis.

The physician will then setup up to 4 stimulation programs will be set up:

1. Clinician-based programming (standard of care), 2. Maximum Beta power-based programming, 3. Broad-band programming. 4. If needed, second-best clinician-based programming (standard of care)

In this study, settings 1, 2, and 4 (optional) are determined based on established standards of care or manufacturer guidelines. Setting 3, however, is derived using our novel electrophysiology-based algorithm. While the method for determining this setting is innovative, the resulting parameter may be identical to those obtained through conventional approaches (settings 1, 2, or 4). Therefore, although the methodology introduces a new process, the final settings remain within clinically accepted ranges and do not exceed standard clinician-based practices.

Вмешательства

  • Устройство Clinician-based DBS programming
    Contacts, amplitude, pulse width, and frequency are chosen by the treating physician during a conventional monopolar review.
  • Устройство Maximum Beta power-based DBS programming
    The contact that shows the strongest beta activity (13-30 Hz) in the local field potentials is selected for stimulation.
  • Устройство Broad-band electrophysiology-based DBS programming
    A multi-frequency algorithm that integrates beta, theta/alpha, finely tuned gamma, and other relevant bands is used to identify the optimal contact.

Первичные конечные точки

  • Assessment of motor symptoms using the Unified Parkinson's Disease Rating Scale (UPDRS) [Срок оценки: From enrollment to end of study (1 month)]

Критерии участия

Критерии включения

  • Patients with a diagnosis of idiopathic PD fulfilling the Movement Disorder Society Clinical Diagnostic Criteria for PD
  • DBS implantation with the Percept DBS device (Medtronic, USA) for the treatment of motor symptoms
  • Ability to give informed consent for the study
  • Willingness to do this study at the time of the initial programming session
  • Age 21 to 89 years old

Критерии исключения

  • Inability to comply with the study protocol
  • Atypical Parkinsonism
  • Any personality or mood symptoms that study personnel believe will interfere with the study requirements

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
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Norman Fixel Institute for Neurological Diseases — Gainesville

Идентификаторы

NCT: NCT07348705 · IRB202500821

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗