Constant Current Versus Constant Voltage Subthalamic Nucleus Deep Brain Stimulation in Patients with Parkinson's Disease

Официальное название

Prospective Study of Constant Current Versus Constant Voltage Deep Brain Stimulation in Patients with Parkinson's Disease

Обзор

To compare the efficacy, programming burden, power consumption, and physicians' and patients' satisfaction between current mode and voltage mode of deep brain stimulation in each period one year after surgery.

Подробное описание

This is a randomized, parallel controlled, multi-center study to compare the efficacy, programming burden, power consumption, and physicians' and patients' satisfaction between current mode and voltage mode of deep brain stimulation in each period one year after surgery. Participants will be followed for up to 12 months. Approximately 180 PD participants will be recruited from up to 14 sites. Participants will be randomized to current mode or voltage mode after DBS surgery and be comprehensively assessed at baseline and follow up according to the protocol developed.

Вмешательства

• Другое Constant current (CC) subthalamic nucleus deep brain stimulation
  For subjects who have decided to undergo STN-DBS surgery and meet the inclusion criteria, the constant current (CC) mode is selected as the original electronic modality one week after surgery. Regardless of any changes in programming parameters over the following year, the constant current (CC) mode will be maintained.
• Другое Constant voltage (CV) subthalamic nucleus deep brain stimulation
  For subjects who have decided to undergo STN-DBS surgery and meet the inclusion criteria, the constant voltage (CV) mode is selected as the original electronic modality one week after surgery. Regardless of any changes in programming parameters over the following year, the constant voltage (CV) mode will be maintained.

Первичные конечные точки

• The change rate of MDS-UPDRS III [Срок оценки: from baseline to 6 months after surgery]

Вторичные конечные точки (9)

• MDS-UPDRS I [Срок оценки: from baseline to 6 months after surgery]
• MDS-UPDRS II [Срок оценки: from baseline to 6 months after surgery]
• MDS-UPDRS IV [Срок оценки: from baseline to 6 months after surgery]
• Clinical Global Impression (CGI) [Срок оценки: from baseline to 6 months after surgery]
• Physician satisfaction feedback [Срок оценки: from baseline to 6 months after surgery]
• Patient satisfaction feedback [Срок оценки: from baseline to 6 months after surgery]
• power consumption [Срок оценки: from baseline to 6 months after surgery]
• impecence [Срок оценки: from baseline to 6 months after surgery]
• Adverse effects [Срок оценки: from baseline to 12 months after surgery]

Критерии участия

Критерии включения

• Patients with idiopathic Parkinson's disease
• Aged 18 to 75, no limited sex
• After bilateral STN-DBS, yet not powered on

Критерии исключения

• Mental disorders or dementia
• Pregnant, lactating women or women who are unable to take effective measures to prevent pregnancy
• Serious health conditions, such as tumors, liver or kidney diseases, etc.
• Epilepsy or other seizure disorders
• Patients with severely deviated electrode placement
• Patients who were unable to voluntarily sign an informed consent form
• Patients who did not agree to cooperate with follow-up

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

Китай · 1 центр

• Xuanwu Hospital of Capital Medical University — Пекин

Идентификаторы

NCT: NCT06742450 · PX2024032

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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