Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study
NCT ID: NCT07216976
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
62 participants
INTERVENTIONAL
2025-11-19
2028-01-31
Brief Summary
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The main question it aims to answer is: To demonstrate at least 50% of subjects meet a success criterion relative to stable cDBS.
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Detailed Description
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The study is expected to be conducted at approximately 5 centers located in China.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single-arm who received aDBS "Best" Mode (Dual or Single Threshold )
Percept™ PC 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.
Interventions
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Percept™ PC 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
General (Assessed at Enrollment Visit):
1. Subject has idiopathic Parkinson's disease
2. Subject is implanted (\>3 months prior to enrollment for new INS implants or \>1 month from INS replacement) with Percept PC (Model B35200) 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
3. In the opinion of the investigator, the subject responds to DBS Therapy.
4. 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
5. Subject is configured to monopolar or dual monopolar stimulation using contacts 1 and/or 2 (9 and/or 10) on at least one side
6. 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)
7. 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
8. 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
General (Assessed at the Enrollment Visit):
1. Subject and/or caregiver is unable to utilize the patient programmer
2. Subject has more than one lead in each hemisphere of the brain
3. Subject has cortical leads or additional unapproved hardware implanted in the brain
4. Subject has more than one INS
5. At enrollment, the subject's INS has a predicted battery life of \<1 year
6. Subject has Beck Depression Inventory II (BDI-II)\>25
7. Subject requires diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT)
8. Subject has a metallic implant in the head, (e.g., aneurysm clip, cochlear implant)
9. Subject has, or plans to obtain, an implanted electrical stimulation medical device anywhere in the body (e.g., cardiac pacemaker, defibrillator, spinal cord stimulator)
10. 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
11. Based on the opinion of the investigator, the subject has an abnormal neurological examination that would preclude them from study participation
12. Subject is breast feeding
13. Subject is under the age of 18 years
14. 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
15. Subjects with signal artifact on all 6 aDBS sense pathways (3 each on both DBS leads) which preclude the clinician from setting thresholds
18 Years
ALL
No
Sponsors
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MedtronicNeuro
INDUSTRY
Responsible Party
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Principal Investigators
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Alex Xie, Clinical Research&Medical Science Director
Role: STUDY_DIRECTOR
Medtronic (Shanghai) Management Co. Ltd.
Locations
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Xuanwu Hospital
Beijing, Beijing Municipality, China
Sun Yat-sen Hospital
Guangzhou, Guangdong, China
Huashan Hospital
Shanghai, Shanghai Municipality, China
Ruijin Hospital
Shanghai, Shanghai Municipality, China
West China Hospital
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MDT 24043
Identifier Type: -
Identifier Source: org_study_id
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