Adaptive DBS for PD
Recruiting now · Not applicable
Conditions studied: Parkinson Disease(PD)
In brief
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.
Key facts
- Study ID
- NCT07635823
- Run by
- Beijing Pins Medical Co., Ltd
- People needed
- 60
- Starts
- 2026-05-16
- Expected to finish
- 2027-09-30
- Last updated by the study team
- 2026-06-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Xiangya Hospital of Central South University — Changsha, Hunan, China (enrolling)
- Nanjing Brain Hospital — Nanjing, Jiangsu, China (enrolling)
- Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
- Xuanwu Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
- The First Affiliated Hospital of USTC (Anhui Provincial Hospital) — Hefei, Anhui, China
- West China Hospital — Chengdu, Sichuan, China
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China
- First Affiliated Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China
- Qilu Hospital of Shandong University — Jinan, Shandong, China
Full record on ClinicalTrials.gov
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