An interventional study of adaptive deep brain stimulation and conventional deep brain stimulation in Parkinson Disease(PD), sponsored by Beijing Pins Medical Co., Ltd. Recruiting at 9 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Beijing Pins Medical Co., Ltd · Not applicable, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 278 studies in Parkinson Disease with a site in China — 129 open to participants now, 136 under way, 3 of them phase 3. Parkinson Disease · China.
Among the 278 studies in Parkinson Disease with a site in China, this one is the 75th largest by planned enrollment of the 210 interventional ones that give a count, is one of 41 that started in 2026, is one of 115 with no phase, reaches primary completion later than 92 of the 135 other live ones, and was the 258th registered.
4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.
Browse Parkinson Disease studies →129 of the 278 studies in Parkinson Disease with a site in China are open now. Recruiting first, the newest first:
The First Affiliated Hospital of Anhui Medical University · Sites in China
Ages 30–75
Hoffmann-La Roche · Sites in China, United States, United Kingdom
Ages 40–85
Shanghai UniXell Biotechnology Co., Ltd · Sites in China
Ages 30–75
Ruijin Hospital · Sites in China
Ages 50–85
Ke Dong, MD · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 750 Parkinson Disease studies recruiting now, 312 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 64 take children under 18; 190 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
278 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 48 · Phase 2 27 · Phase 3 23 · Phase 4 11
First in 2003; this study’s year is marked. 41 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is above the median of 40 across 3,355 interventional studies indexed under Parkinson Disease.
Median enrollment 48 across the 210 interventional studies, 215 across the 68 observational. Of the 95 that completed or were terminated, 19 (20%) have results posted.
This tab as a report to print or save as PDF → With an account.
63 of 278 have an industry lead sponsor. The 10 most frequent:
Beijing Pins Medical Co., Ltd is the lead sponsor of 31 studies on the registry; 5 are open to participants now.
Beijing Pins Medical Co., Ltd has 6 studies filed under Parkinson Disease — fewer than ten, so there is no comparison to draw.
41 of the studies in Parkinson Disease with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07725562Phase 3Zhejiang Vimgreen Pharmaceuticals, Ltd.VG081821AC Tablets for Early to Mid-stage Parkinson's Disease | 2027-10-01 |
| NCT07028632iRegene Therapeutics Co., Ltd.The Safety, Feasibility and Efficacy of NouvNeu001 for Parkinson's Disease | 2026-12 |
| NCT07604116Synusight Biotech (Shanghai) Co., Ltd.A Study to Evaluate Satety, Tolerability, Biodistribution, Radiation Dosimetry, and Pharmacokinetics of SST001 in Healthy Volunteers, Patients With PD and Patients With MSA | 2026-12 |
| NCT06642454Anhui Medical UniversityA Randomized Double-Blind Active-Controlled Crossover Trial of Respiratory-Gated Versus Non-Gated Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Motor and Non-Motor Symptoms in Parkinson's Disease | 2026-12-01 |
| NCT07384429YangPanEffects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease | 2026-12-01 |
Add all 41 to your calendar (.ics) → With an account.
Among the 278 studies in Parkinson Disease with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to evaluate the efficacy and safety of an adaptive deep brain stimulation (aDBS) system for managing Parkinson's disease symptoms. Researchers will compare closed-loop stimulation (which automatically adjusts therapy using real-time brain signals and sleep monitoring) against traditional continuous stimulation (fixed settings) in a randomized, double-blind, crossover study. Participants will undergo surgical implantation of PINS Medical's G1010R neurostimulator, followed by alternating treatment phases where each patient experiences both aDBS and conventional open-loop stimulation modes. Outcomes will assess improvements in without troublesome dyskinesia daily time, motor symptoms (e.g., tremors, rigidity), quality of life, and sleep quality across both therapy periods.
The goal of this clinical trial is to evaluate the efficacy and safety of PINS Medical's rechargeable implantable closed-loop deep brain stimulation (aDBS) system for improving quality of life in Parkinson's disease patients. Researchers will compare adaptive closed-loop stimulation (which automatically adjusts therapy using real-time brain signals) against conventional open-loop stimulation (cDBS) in a prospective, multicenter, double-blind, randomized crossover study. Participants will undergo surgical implantation of the neurostimulator system and progress through five trial phases: screening/surgery, cDBS optimization, aDBS optimization, crossover evaluation, and long-term follow-up across nine visits. During crossover testing, each participant will experience both stimulation modes sequentially while blinded. Key outcomes include duration of troublesome/non-troublesome dyskinesia, "off" time, sleep scales (VAS, PDSS-2, PSQI), motor symptoms (MDS-UPDRS), quality of life (PDQ-39, EQ-5D-5L), and safety parameters. The primary analysis will occur after all randomized subjects complete crossover testing and unblinding (Visit 7).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects must meet one of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will first take conventional DBS treatment for 30-45 days, then change to adaptive DBS treatment for another 30-45 days.
Device: adaptive deep brain stimulation · Device: conventional deep brain stimulation
Participants in this group will first take adaptive DBS treatment for 30-45 days, then change to conventional DBS treatment for another 30-45 days.
Device: adaptive deep brain stimulation · Device: conventional deep brain stimulation
adaptive deep brain stimulation (aDBS) is a stimulation mode that measuring local field potential (LFP) signal nearby the electrodes of lead in the deep brain and decoding the signal in real-time, automatically adjusts amplitude of stimulation controlled by algorithm embedded in DBS device. aDBS is able to recognize patient status and allocate proper stimulation parameters based on need to treat Parkinson symptoms.
Also known as: closed-loop deep brain stimulation, aDBS, adaptive DBS
conventional deep brain stimulation is a common stimulation mode that has been used for years. It uses fixed stimulation parameters to treat Parkinson's disease and has been proved effective to motor symptoms.
Also known as: cDBS, traditional deep brain stimulation, conventional DBS, open-loop DBS
Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold
In the Motor-Sleep Diary, in 30-minute intervals, patients recorded whether they were in the "On" condition (with dyskinesia, with non-troublesome dyskinesia, with troublesome dyskinesia), "Off" condition, or asleep. The "On" time without troublesome dyskinesia combined the categories of "On" time without dyskinesia and "On" time with non-troublesome dyskinesia. The Motor-Sleep Diary was collected at both the cDBS treatment and aDBS treatment during the crossover evaluation phases. The threshold was determined using the hours of "On" time without troublesome dyskinesia for aDBS is no worse than 2 hours per day less than cDBS. The proportion of aDBS subjects exceeding the threshold was the primary endpoint.
Time frame: about one month each after randomization
Motor-sleep dairy
In the Motor-sleep Diary, in 30-minute intervals, patients recorded whether they were in the "On" condition (with dyskinesia, with non-troublesome dyskinesia, with troublesome dyskinesia), "Off" condition, or asleep. The Motor-sleep Diary also collects a visual analogue scale that subjects use to evaluate overall quality of sleep last night. The "On" time without troublesome dyskinesia combined the categories of "On" time without dyskinesia and "On" time with non-troublesome dyskinesia. The Motor-sleep Diary was collected at the cDBS treatment and aDBS treatment during crossover evaluation phases. Motor-sleep Diary collects 5 measurements: 1. daily "On" time without troublesome dyskinesia 2. daily "On" time with troublesome dyskinesia 3. daily "Off" time 4. daily asleep time 5. quality of sleep The result of 2 type of treatments and baseline will be compared.
Time frame: about one month after randomization
MDS UPDRS
The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) contains 4 parts. Each parts range as the following: 0\~52, 0\~52, 0\~132, 0\~24. Lower score means better rating on the according symptoms. Each measures different perspective of motor disorder. In this trial, 5 measurements will be collected: 1. MDS UPDRS part I 2. MDS UPDRS part II ("best" condition) 3. MDS UPDRS part II ("worst" condition) 4. MDS UPDRS part III 5. MDS UPDRS part IV Each measurements will be collected at cDBS treatment and aDBS treatment during crossover phases. The result of each treatment will be compared.
Time frame: about one month after randomization
PDSS-2
Parkinson's Disease Sleep Scale 2(PDSS-2) measures the quality of sleep of Parkinson's Disease. The scale ranges from 0 to 60. Lower score means better rating on sleep conditions. Measurement will be collected at cDBS treatment and aDBS treatment during crossover phases. The result of each treatment will be compared.
Time frame: about one month after randomization
PSQI
Pittsburgh sleep quality index(PSQI) measures the quality of sleep. The scale ranges from 0 to 21. Lower score means better rating on the quality of sleep. Measurement will be collected at cDBS treatment and aDBS treatment during crossover phases. The result of each treatment will be compared.
Time frame: about one month after randomization
PDQ-39
Parkinson's Disease Questionnaire-39(PDQ-39) measures the quality of life of Parkinson's Disease, containing 39 items that range from 0 to 4. The final score is computed through the following steps: 1. calculate the average score of every item in 8 dimensions and span the results to a range from 0 to 100; 2. calculate the average score of all dimensions. The final score ranges from 0 to 100. Lower score means better rating on the quality of life. Measurement will be collected at cDBS treatment and aDBS treatment during crossover phases and 2 follow-up visits after crossover. The result of each treatment will be compared. Overall result will be analyzed descriptively.
Time frame: about 6 months after randomization
EQ-5D-5L
EQ-5D-5L measures the quality of life, containing 5 questions and 1 visual analogue scale(VAS) for rating of subjective conclusive quality of life. The results of 5 questions form a state code of 5 digits. The state code will be transformed to EQ-5D index score using a values set for China. Measurements will be collected at cDBS treatment and aDBS treatment during crossover phases and 2 follow-up visits after crossover. The results of each treatment will be compared. Overall result will be analyzed descriptively.
Time frame: about 6 months after randomization
Patient Preference Questionnaire
Patient Preference Questionnaire measures the preference to each treatments while blinded. The questionnaire contains 6 independent questions. Each option of every question will be counted as a percentage. Measurement will be collected at the end of last crossover phase before unblinding. The result of each treatment will be compared and analyzed descriptively.
Time frame: about 2 months after randomization
Patient Satisfaction Questionnaire
Patient Satisfaction Questionnaire measures the satisfaction with each treatments. The questionnaire contains 3 independent questions. Each option of every question will be counted as a percentage. Measurement will be collected at the end of entire trial before completion. The result of each treatment will be compared and analyzed descriptively.
Time frame: about 6 months after randomization
Recharging DBS Experience
Recharging DBS Experience measures the experience of subject recharge DBS device under each treatment. It is evaluated by recharging interval and accumulation of electric energy depletion. The numeric results are calculated using DBS recharging dairy embedded in the device. The more frequently recharge or the more electric energy is depleted, the poor experience the subjects have. The measurements will be collected for each treatment during crossover phase and will be compared.
Time frame: about one month after randomization
TEED
Total Electric Energy Delivered(TEED) measures the amount of energy consumed by stimulation for each treatment. The numeric result are estimated by DBS stimulation parameters. The measurements will be collected for each treatment during crossover phase and will be compared.
Time frame: about one month after randomization
Peripheral Device Measurements
Peripheral device measurements include motor and sleep metrics that can offer extra symptom analysis. The measurements will be collected for each treatment during crossover phase and will be compared.
Time frame: about one month after randomization
GIC
The Global Impression Change Score(GIC) measure the acceptance of each treatment after programming compared to the previous treatment. It is evaluated by subject using effectiveness and side effect to acquire a status code that can be analyzed descriptively. The measurements will be collected for each treatment during adjustment phase and will be compared.
Time frame: about 14 days after programming during adjustment phase
Plan to share: No
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for May 2027, 12 months after the start.
Of 76 industry-sponsored interventional studies with no phase under Parkinson Disease, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 43. This study's planned 12 months is below that.
Counting every sponsor, half of 1,370 studies reached it within 25 months; a quarter within 12 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Beijing Pins Medical Co., Ltd →