Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

Обзор

The purpose of the study is to evaluate the effectiveness of the Medtronic Adaptive DBS therapy (aDBS) for Parkinson's Disease in China with the Percept family of Implantable Neurostimulators (Percept PC and Percept RC).

Подробное описание

The ADAPT-PD China Study will utilize both Dual and Single Threshold aDBS modes (algorithms). Prospective, multicenter, open label comparison (with single-blind aDBS mode from aDBS randomization to evaluation phase), single arm clinical trial designed to evaluate the effectiveness of the Medtronic Adaptive DBS therapy (aDBS) for Parkinson's Disease in China with the Percept family of Implantable Neurostimulators (Percept PC and Percept RC).

The study is expected to be conducted at approximately 5 centers located in China.

Вмешательства

• Устройство Percept™ PC and Percept RC with Adaptive DBS (aDBS™)
  Subjects for whom meet the LFP screening criteria and can be acceptably configured on the "Best" aDBS mode (Dual or Single Threshold) will receive "Best" Mode aDBS treatment and enter the aDBS Evaluation Phase.

Первичные конечные точки

• "On" time without troublesome dyskinesia (i.e. Good "On" Time) [Срок оценки: From the cDBS baseline to aDBS evaulation phase at about 1 month]

Критерии участия

Критерии включения

• Subjects must meet all general inclusion/exclusion criteria (as assessed at the Enrollment Visit)
• Subjects must meet the LFP screening inclusion criterion (as assessed at the LFP Screening Visit)

General (Assessed at Enrollment Visit):

• Subject has idiopathic Parkinson's disease
• Subject is implanted (>3 months prior to enrollment for new INS implants or >1 month from INS replacement) with a Percept PC (Model B35200) or Percept RC (Model B35300) and Medtronic DBS leads (Model 3387, 3389, B33005 or B33015) and extensions (Model 37086 or B34000) bilaterally in the same target (physician confirmed), STN or GPi
• In the opinion of the investigator, the subject responds to DBS Therapy.
• Based on the opinion of the investigator, the subject's cDBS parameters and PD medications are stable (no changes within the last 4 weeks) and expected to remain stable from enrollment through the end of the aDBS Evaluation Phase
• Subject is configured to monopolar or dual monopolar stimulation using contacts 1 and/or 2 (9 and/or 10) on at least one side
• Subject is willing and able to attend all study-required visits and complete the study procedures (e.g. 1-month recall questionnaires, MDS-UPDRS III, Off stim/Off med visit)
• Subject (or legally authorized representative) has the ability to understand and provide written informed consent for participation in the study prior to the study-related procedures being conducted
• Subject is a male or non-pregnant female. If female of child-bearing potential, and if sexually active, must be using, or agree to use, a medically-acceptable method of birth control as confirmed by the investigator

LFP Screening Inclusion Criteria (Conducted during LFP Screening Visit):

1\. Subject has Alpha - Beta band (8-30 Hz) amplitude ≥ 1.2 μVp detected on either left and/or right DBS leads on sensing channels 0-2, 0-3, 1-3, 8-10, 8-11, or 9-11.

Критерии исключения

General (Assessed at the Enrollment Visit):

• Subject and/or caregiver is unable to utilize the patient programmer
• Subject has more than one lead in each hemisphere of the brain
• Subject has cortical leads or additional unapproved hardware implanted in the brain
• Subject has more than one INS
• At enrollment, the subject's INS has a predicted battery life of <1 year
• Subject has Beck Depression Inventory II (BDI-II)>25
• Subject requires diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT)
• Subject has a metallic implant in the head, (e.g., aneurysm clip, cochlear implant)
• Subject has, or plans to obtain, an implanted electrical stimulation medical device anywhere in the body (e.g., cardiac pacemaker, defibrillator, spinal cord stimulator)
• Subject has, or plans to obtain, an implanted medication pump for the treatment of Parkinson's disease (e.g., DUOPATM infusion pump) and/or portable infusion pump
• Based on the opinion of the investigator, the subject has an abnormal neurological examination that would preclude them from study participation
• Subject is breast feeding
• Subject is under the age of 18 years
• Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study as determined by the Medtronic study team
• Subjects with signal artifact on all 6 aDBS sense pathways (3 each on both DBS leads) which preclude the clinician from setting thresholds

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

Китай · 5 центров

• Xuanwu Hospital — Пекин
• Sun Yat-sen Hospital — Гуанчжоу
• Huashan Hospital — Шанхай
• Ruijin Hospital — Шанхай
• West China Hospital — Чэнду

Идентификаторы

NCT: NCT07216976 · MDT24043

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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