Actively Recruiting
Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study
Led by MedtronicNeuro · Updated on 2026-03-11
62
Participants Needed
5
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of the Medtronic Adaptive Deep Brain Stimulation (aDBS) therapy for Parkinson's Disease in China. It focuses on using the Percept family of Implantable Neurostimulators, including Percept PC and Percept RC devices, to provide personalized treatment. The study is open-label, prospective, and multicenter, designed to assess how well this technology works for patients with Parkinson's Disease. Participants will receive either Dual or Single Threshold aDBS modes as part of the treatment algorithm. Those who meet specific screening criteria will be configured on their "Best" aDBS mode and then enter an evaluation phase. The trial is conducted across approximately five centers in China, with all participants receiving the adaptive DBS treatment without a comparison group. During the study, participants will attend multiple visits including a screening phase and an evaluation phase approximately one month after starting aDBS therapy. Assessments include questionnaires, clinical rating scales like MDS-UPDRS III, and device programming evaluations. The main measurement will be the amount of "On" time without troublesome dyskinesia, comparing baseline conventional DBS to adaptive DBS. Participants must be able to complete all study procedures and provide informed consent, with ongoing monitoring throughout the study period.
CONDITIONS
Brief Title
Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or Percept RC and Medtronic DBS leads bilaterally in the same target (STN or GPi)
- Subject responds to DBS therapy as confirmed by investigator
- Subject's cDBS parameters and PD medications are stable with no changes within the last 4 weeks
- Subject is configured to monopolar or dual monopolar stimulation using specific contacts on at least one side
- Subject is willing and able to attend all study visits and complete procedures
- Subject or legally authorized representative can provide written informed consent
- Subject is male or non-pregnant female; females of child-bearing potential must use acceptable birth control
- Subject meets LFP screening criterion with Alpha-Beta band amplitude ≥ 1.2 µVp on DBS leads
You will not qualify if you...
- Subject or caregiver unable to use patient programmer
- Subject has more than one lead in each brain hemisphere
- Subject has cortical leads or additional unapproved brain hardware
- Subject has more than one implantable neurostimulator
- Subject's implantable neurostimulator battery life predicted to be less than 1 year
- Subject has Beck Depression Inventory II (BDI-II) score greater than 25
- Subject requires diathermy, transcranial magnetic stimulation, or electroconvulsive therapy
- Subject has metallic implants in the head (e.g., aneurysm clip, cochlear implant)
- Subject has or plans to obtain implanted electrical stimulation devices elsewhere in the body
- Subject has or plans to obtain implanted medication pumps for Parkinson's treatment
- Subject has abnormal neurological exam preventing study participation
- Subject is breastfeeding
- Subject is under 18 years old
- Subject is enrolled or plans to enroll in conflicting drug or device studies
- Subject has signal artifacts on all aDBS sensing pathways preventing threshold settings
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - About 1 month
Participants receive adaptive DBS therapy using the Percept PC or Percept RC neurostimulators with the best aDBS mode (Dual or Single Threshold) configured for personalized therapy.
Multiple visits during the evaluation phase
Trial Site Locations
Total: 5 locations
1
Xuanwu Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
2
Sun Yat-sen Hospital
Guangzhou, Guangdong, China
Actively Recruiting
3
Huashan Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
4
Ruijin Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
5
West China Hospital
Chengdu, Sichuan, China
Actively Recruiting
Research Team
J
Jane Zhang, Principle Clinical Research Specialist
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here