Adaptive DBS for personalized Parkinson's therapy in China

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

This study will test whether Medtronic's Adaptive Deep Brain Stimulation (aDBS) using Percept PC or Percept RC devices helps people in China with Parkinson's disease who already have those implants.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: MedtronicNeuro (Industry-sponsored)
• Locations: 5 sites (Beijing, Beijing Municipality and 4 other locations)
• Trial ID: NCT07216976 on ClinicalTrials.gov

What this trial studies

ADAPT-PD China is a prospective, multicenter, open-label, single-arm trial using Medtronic's Percept PC and Percept RC systems with Dual and Single Threshold adaptive DBS algorithms. Eligible participants (bilateral STN or GPi implants) undergo LFP screening and are randomized to an aDBS mode for a single-blind evaluation phase compared with their baseline conventional DBS settings. The trial collects local field potential data to guide personalized stimulation adjustments and measures clinical symptom control and device performance. The study is planned at about five centers across China.

Who should consider this trial

Good fit: Ideal candidates are people with idiopathic Parkinson's disease who respond to DBS, have bilateral Percept PC or Percept RC implants (STN or GPi), have stable medications and programming, and pass the LFP screening.

Not a fit: People without Percept PC/RC implants, with unilateral or nonstandard lead placement, non-idiopathic parkinsonism, unstable medications or device settings, or who fail the LFP screening are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, adaptive DBS could improve symptom control and reduce stimulation-related side effects or device energy use by adjusting stimulation to each person's brain signals.

How similar studies have performed: Prior smaller studies of adaptive DBS have shown promising symptom improvement and reduced stimulation time, but large multicenter evidence is still limited.

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

Where this trial is running

Beijing, Beijing Municipality and 4 other locations

• Xuanwu Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Sun Yat-sen Hospital — Guangzhou, Guangdong, China (Recruiting)
• Huashan Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• Ruijin Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• West China Hospital — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Jane Zhang, Principle Clinical Research Specialist

Conditions Parkinson's Disease; Deep Brain Stimulation