Adaptive DBS for PD

Официальное название

Adaptive vs Conventional Deep Brain Stimulation for Parkinson's Disease: A Multi-center Randomized Controlled Trial

Обзор

The goal of this clinical trial is to evaluate the efficacy and safety of an adaptive deep brain stimulation (aDBS) system for managing Parkinson's disease symptoms. Researchers will compare closed-loop stimulation (which automatically adjusts therapy using real-time brain signals and sleep monitoring) against traditional continuous stimulation (fixed settings) in a randomized, double-blind, crossover study. Participants will undergo surgical implantation of PINS Medical's G1010R neurostimulator, followed by alternating treatment phases where each patient experiences both aDBS and conventional open-loop stimulation modes. Outcomes will assess improvements in without troublesome dyskinesia daily time, motor symptoms (e.g., tremors, rigidity), quality of life, and sleep quality across both therapy periods.

Подробное описание

The goal of this clinical trial is to evaluate the efficacy and safety of PINS Medical's rechargeable implantable closed-loop deep brain stimulation (aDBS) system for improving quality of life in Parkinson's disease patients. Researchers will compare adaptive closed-loop stimulation (which automatically adjusts therapy using real-time brain signals) against conventional open-loop stimulation (cDBS) in a prospective, multicenter, double-blind, randomized crossover study. Participants will undergo surgical implantation of the neurostimulator system and progress through five trial phases: screening/surgery, cDBS optimization, aDBS optimization, crossover evaluation, and long-term follow-up across nine visits. During crossover testing, each participant will experience both stimulation modes sequentially while blinded. Key outcomes include duration of troublesome/non-troublesome dyskinesia, "off" time, sleep scales (VAS, PDSS-2, PSQI), motor symptoms (MDS-UPDRS), quality of life (PDQ-39, EQ-5D-5L), and safety parameters. The primary analysis will occur after all randomized subjects complete crossover testing and unblinding (Visit 7).

Вмешательства

• Устройство adaptive deep brain stimulation
  adaptive deep brain stimulation (aDBS) is a stimulation mode that measuring local field potential (LFP) signal nearby the electrodes of lead in the deep brain and decoding the signal in real-time, automatically adjusts amplitude of stimulation controlled by algorithm embedded in DBS device. aDBS is able to recognize patient status and allocate proper stimulation parameters based on need to treat Parkinson symptoms.
• Устройство conventional deep brain stimulation
  conventional deep brain stimulation is a common stimulation mode that has been used for years. It uses fixed stimulation parameters to treat Parkinson's disease and has been proved effective to motor symptoms.

Первичные конечные точки

• Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold [Срок оценки: about one month each after randomization]

Критерии участия

Критерии включения

• idiopathic Parkinson's disease
• Hoehn \& Yahr (HY) stage 2.5-4 during medication "OFF"
• Subjects must meet one of the following:

• Never underwent DBS surgery and suitable for bilateral STN or GPi DBS surgery;
• Previous bilateral STN/GPi DBS recipients with only one IPG who:
• Demonstrate responsiveness to conventional cDBS therapy per investigator evaluation,
• Consent to device replacement with G1010R DBS system.
• Willing and physically/mentally able to complete all study visits and procedures
• Capable of comprehending and providing written informed consent

Критерии исключения

• Presence of contraindications to deep brain stimulation (DBS) surgery.
• Beck Depression Inventory-II (BDI-II) score > 25
• Mini-Mental State Examination (MMSE) score < 24 (adjusted for educational level)
• Significant comorbidities that may interfere with DBS therapy per investigator assessment.
• Pre-existing active non-DBS medical implants or metallic cranial implants
• Requirement for diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT) during the study period
• History of ablative neurosurgery or stem cell therapy for Parkinson's disease
• Inability to complete ≥3 consecutive days of comprehensive motor/sleep diaries
• Inability to maintain prescribed medication regimens or comply with protocol requirements
• Current pregnancy, lactation, or planned pregnancy during the study period
• Other conditions deemed by investigators to compromise study suitability
• Participation in other interventional clinical trials within 4 weeks prior to consent

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 9 центров

• The First Affiliated Hospital of USTC (Anhui Provincial Hospital) — Хэфэй
• Beijing Tiantan Hospital, Capital Medical University — Пекин
• Xuanwu Hospital, Capital Medical University — Пекин
• Peking Union Medical College Hospital — Пекин
• First Affiliated Hospital, Sun Yat-Sen University — Гуанчжоу
• Xiangya Hospital of Central South University — Чанша
• Nanjing Brain Hospital — Нанкин
• Qilu Hospital of Shandong University — Цзинань
• … и ещё 1 центр

Идентификаторы

NCT: NCT07635823 · G1010R&PINS-C2-01-53

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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