Adaptive DBS for PD
Recruiting · NCT07635823 · Interventional (participants receive a specific treatment) · Lead sponsor: Beijing Pins Medical Co., Ltd
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- Presence of contraindications to deep brain stimulation (DBS) surgery.
- Beck Depression Inventory-II (BDI-II) score \> 25
- Mini-Mental State Examination (MMSE) score \< 24 (adjusted for educational level)
- 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
- History of ablative neurosurgery or stem cell therapy for Parkinson's disease
- Inability to complete ≥3 consecutive days of comprehensive motor/sleep diaries
- Inability to maintain prescribed medication regimens or comply with protocol requirements
- Current pregnancy, lactation, or planned pregnancy during the study period
- Other conditions deemed by investigators to compromise study suitability
- Participation in other interventional clinical trials within 4 weeks prior to consent
Where it is running
9 locations listed.
- The First Affiliated Hospital of USTC (Anhui Provincial Hospital) - Hefei, Anhui, China
- Beijing Tiantan Hospital, Capital Medical University - Beijing, Beijing Municipality, China
- Xuanwu Hospital, Capital Medical University - Beijing, Beijing Municipality, China
- Peking Union Medical College Hospital - Beijing, Beijing Municipality, China
- First Affiliated Hospital, Sun Yat-Sen University - Guangzhou, Guangdong, China
- Xiangya Hospital of Central South University - Changsha, Hunan, China
- Nanjing Brain Hospital - Nanjing, Jiangsu, China
- Qilu Hospital of Shandong University - Jinan, Shandong, China
- West China Hospital - Chengdu, Sichuan, China