Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study
1 other identifier
interventional
62
1 country
5
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2025
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2025
CompletedFirst Posted
Study publicly available on registry
October 15, 2025
CompletedStudy Start
First participant enrolled
November 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
March 11, 2026
March 1, 2026
1.1 years
October 9, 2025
March 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
"On" time without troublesome dyskinesia (i.e. Good "On" Time)
Proportion of aDBS subjects meet a success criterion relative to stable cDBS.The success criterion: no worse than 2 hours/day less of "On" time without troublesome dyskinesia (i.e. Good "On" Time) during aDBS compared to cDBS.
From the cDBS baseline to aDBS evaulation phase at about 1 month
Other Outcomes (1)
Assess the Adverse Event among the Participants
From enrollment to the end of treatment at around 12 months to 17.5 months
Study Arms (1)
Single-arm who received aDBS "Best" Mode (Dual or Single Threshold )
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may not qualify if:
- 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
- \. 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.
- 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
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedtronicNeurolead
Study Sites (5)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alex Xie, Clinical Research&Medical Science Director
Medtronic (Shanghai) Management Co. Ltd.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2025
First Posted
October 15, 2025
Study Start
November 19, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
Due to the personal data protection, the IPD for each site will only be used for this study purpose and will only be opened for site investigators. Also, the informed consent doesn't include sharing IPD with other researchers.