NCT07216976 Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study
| NCT ID | NCT07216976 |
| Status | Recruiting |
| Phase | — |
| Sponsor | MedtronicNeuro |
| Condition | Parkinson's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2025-11-19 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 62 participants in total. It began in 2025-11-19 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
Inclusion Criteria: 1. Subjects must meet all general inclusion/exclusion criteria (as assessed at the Enrollment Visit) 2. Subjects must meet the LFP screening inclusion criterion (as assessed at the LFP Screening Visit) 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 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 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 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): 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
Contact & Investigator
Alex Xie, Clinical Research&Medical Science Director
STUDY DIRECTOR
Medtronic (Shanghai) Management Co. Ltd.
Frequently Asked Questions
Who can join the NCT07216976 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Parkinson's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07216976 currently recruiting?
Yes, NCT07216976 is actively recruiting participants. Contact the research team at jane.zhang7@medtronic.com for enrollment information.
Where is the NCT07216976 trial being conducted?
This trial is being conducted at Beijing, China, Guangzhou, China, Shanghai, China, Shanghai, China and 1 additional location.
Who is sponsoring the NCT07216976 clinical trial?
NCT07216976 is sponsored by MedtronicNeuro. The principal investigator is Alex Xie, Clinical Research&Medical Science Director at Medtronic (Shanghai) Management Co. Ltd.. The trial plans to enroll 62 participants.
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