Tests adaptive brain stimulation for Parkinson's disease symptoms
Compares self-adjusting brain stimulation with fixed stimulation in adults with Parkinson's disease.
Plain-language title generated from the registry record
Registry title: Adaptive DBS for PD
Key facts
- Where
- Beijing, Changsha, Chengdu, Guangzhou, Hefei, Jinan, and Nanjing, ChinaSee the 9 sites
Where in China
- Beijing Tiantan Hospital,Capital Medical UniversityBeijing, ChinaTaking people
- Peking Union Medical College HospitalBeijing, ChinaNot yet recruiting
- Xuanwu Hospital, Capital Medical UniversityBeijing, ChinaTaking people
- Xiangya Hospital of Central South UniversityChangsha, ChinaTaking people
- West China HospitalChengdu, ChinaNot yet recruiting
- First Affiliated Hospital, Sun Yat-Sen UniversityGuangzhou, ChinaNot yet recruiting
- The First Affiliated Hospital of USTC(Anhui Provincial Hospital)Hefei, ChinaNot yet recruiting
- Qilu Hospital of Shandong UniversityJinan, ChinaNot yet recruiting
- Nanjing Brain HospitalNanjing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beijing Pins Medical Co., Ltd
- Trial code
- NCT07635823
- Record updated
- 22 June 2026
- Original description
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.Read full original descriptionShow less
Adaptive vs Conventional Deep Brain Stimulation for Parkinson's Disease: A Multi-center Randomized Controlled Trial
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.
Inclusion: idiopathic Parkinson's disease; Hoehn \& Yahr (HY) stage 2.5-4 during medication "OFF"; Subjects must meet one of the following:; Never underwent DBS surgery and suitable for bilateral STN or GPi DBS surgery; Previous bilateral STN/GPi DBS recipients with only one IPG who:; Demonstrate responsiveness to conventional cDBS therapy per investigator evaluation,; Consent to device replacement with G1010R DBS system; Willing and physically/mentally able to complete all study visits and procedures; Capable of comprehending and providing written informed consent.
Exclusion: Presence of contraindications to deep brain stimulation (DBS) surgery; Significant comorbidities that may interfere with DBS therapy per investigator assessment; Pre-existing active non-DBS medical implants or metallic cranial implants; Requirement for diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT) during the study period; Inability to maintain prescribed medication regimens or comply with protocol requirements; Participation in other interventional clinical trials within 4 weeks prior to consent; History of ablative neurosurgery or stem cell therapy for Parkinson's disease; Other conditions deemed by investigators to compromise study suitability; Beck Depression Inventory-II (BDI-II) score > 25; Mini-Mental State Examination (MMSE) score < 24 (adjusted for educational level); Inability to complete ≥3 consecutive days of comprehensive motor/sleep diaries; Current pregnancy, lactation, or planned pregnancy during the study period.