Parkinson's DiseaseNCT07216976
Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study
A study testing Percept™ PC and Percept RC with Adaptive DBS (aDBS™) in people with Parkinson's Disease, run by MedtronicNeuro at 5 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Percept™ PC and Percept RC with Adaptive DBS (aDBS™)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 5 sitesChina
- Study dates
- 19 Nov 2025to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all general inclusion/exclusion criteria (as assessed at the Enrollment Visit)
- Subjects must meet the LFP screening inclusion criterion (as assessed at the LFP Screening Visit)
- 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.
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- 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
- 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.
Who cannot join
- 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
- At enrollment, the subject's INS has a predicted battery life of <1 year
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- Subject has Beck Depression Inventory II (BDI-II)>25
- Subject requires diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT)
- Subject has a metallic implant in the head, (e.g., aneurysm clip, cochlear implant)
- Subject has, or plans to obtain, an implanted electrical stimulation medical device anywhere in the body (e.g., cardiac pacemaker, defibrillator, spinal cord stimulator)
- 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
- Based on the opinion of the investigator, the subject has an abnormal neurological examination that would preclude them from study participation
- Subject is breast feeding
- Subject is under the age of 18 years
- 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
- Subjects with signal artifact on all 6 aDBS sense pathways (3 each on both DBS leads) which preclude the clinician from setting thresholds
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Xuanwu Hospital
Beijing, Beijing Municipality
West China Hospital
Chengdu, Sichuan
Sun Yat-sen Hospital
Guangzhou, Guangdong
Huashan Hospital
Shanghai, Shanghai Municipality
Ruijin Hospital
Shanghai, Shanghai Municipality
About this study
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).
Read the detailed description
The ADAPT-PD China Study will utilize both Dual and Single Threshold aDBS modes (algorithms). Prospective, multicenter, open label comparison (with single-blind aDBS mode from aDBS randomization to evaluation phase), single arm clinical trial designed 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).
The study is expected to be conducted at approximately 5 centers located in China.
- Conditions
- Parkinson's Disease
- Being tested
- Percept™ PC and Percept RC with Adaptive DBS (aDBS™)
- Keywords
- Deep Brain Stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percept™ PC and Percept RC with Adaptive DBS (aDBS™)Device
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm who received aDBS "Best" Mode (Dual or Single Threshold ) | Experimental | Not described Receives: Device: Percept™ PC and Percept RC with Adaptive DBS (aDBS™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
"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.
Measured: From the cDBS baseline to aDBS evaulation phase at about 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2025
- Study start19 Nov 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alex Xie, Clinical Research&Medical Science Director, Study director, Medtronic (Shanghai) Management Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216976
- Sponsor's protocol ID
- MDT24043
- Status last verified
- Sep 2026
- First submitted
- 9 Oct 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study
- ClinicalTrials.gov ID
- NCT07216976
- Acronym / sponsor ID
- MDT24043
- Conditions
- Parkinson's Disease
- Keywords
- Deep Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 61 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 15 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The ADAPT-PD China Study will utilize both Dual and Single Threshold aDBS modes (algorithms). Prospective, multicenter, open label comparison (with single-blind aDBS mode from aDBS randomization to evaluation phase), single arm clinical trial designed 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).
The study is expected to be conducted at approximately 5 centers located in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm who received aDBS "Best" Mode (Dual or Single Threshold ) | Experimental | Device: Percept™ PC and Percept RC with Adaptive DBS (aDBS™) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects must meet all general inclusion/exclusion criteria (as assessed at the Enrollment Visit)
- Subjects must meet the LFP screening inclusion criterion (as assessed at the LFP Screening 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.
Key exclusion criteria (16 listed)
- 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
- At enrollment, the subject's INS has a predicted battery life of <1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percept™ PC and Percept RC with Adaptive DBS (aDBS™)Also: aDBSSubjects 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. | Device | Single-arm who received aDBS "Best" Mode (Dual or Single Threshold ) |
Primary outcome
"On" time without troublesome dyskinesia (i.e. Good "On" Time)
Time frame: From the cDBS baseline to aDBS evaulation phase at about 1 month
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex Xie, Clinical Research&Medical Science Director study director
Medtronic (Shanghai) Management Co. Ltd.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percept™ PC and Percept RC with Adaptive DBS (aDBS™) in people with Parkinson's Disease, run by MedtronicNeuro at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"On" time without troublesome dyskinesia (i.e. Good "On" Time) (time frame: From the cDBS baseline to aDBS evaulation phase at about 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.