Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Percept™ PC and Percept RC with Adaptive DBS (aDBS™).
- Who it may be relevant to
- Registry conditions: Parkinson's Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Detailed description
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.
Interventions
- Device 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.
Primary outcome measures
- "On" time without troublesome dyskinesia (i.e. Good "On" Time) [Time frame: From the cDBS baseline to aDBS evaulation phase at about 1 month]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 5 centers
- Xuanwu Hospital — Beijing
- Sun Yat-sen Hospital — Guangzhou
- Huashan Hospital — Shanghai
- Ruijin Hospital — Shanghai
- West China Hospital — Chengdu
Identifiers
NCT: NCT07216976 · MDT24043