RecruitingNot ApplicableNCT07635823

Adaptive DBS for PD RCT

Adaptive vs Conventional Deep Brain Stimulation for Parkinson's Disease: A Multi-center Randomized Controlled Trial

Sponsor

Beijing Pins Medical Co., Ltd

Enrollment

60 participants

Start Date

May 16, 2026

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease (PD)

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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 Criteria12

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

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Interventions

DEVICEadaptive 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.

DEVICEconventional deep brain stimulation

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.