Parkinson Disease(PD)
Conditions
Keywords
Parkinson Disease, Deep brain stimulation, Adaptive DBS, Close-loop DBS, Dyskinesia
Brief 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.
Detailed description
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).
Interventions
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.
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.
Sponsors
Beijing Pins Medical Co., Ltd
Beijing Tiantan Hospital
Xuanwu Hospital, Beijing
Nanjing Brain Hospital
Qilu Hospital of Shandong University
West China Hospital
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Peking Union Medical College Hospital
Xiangya Hospital of Central South University
First Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Masking starts at the moment when randomization is completed and ends at the end of crossover phases. Only the investigator who is responsible for configuring, adjusting, and optimizing stimulation parameters throughout all trial phases is not blinded. Masking is conducted by software setup. Anyone having access to the programming device (tablet) is unable to see whether adaptive stimulation mode is turned on or off unless knowing the password and the entry to this info.
Intervention model description
This is a multi-center, blinded, crossover, randomized controlled study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* idiopathic Parkinson's disease * Hoehn \& Yahr (HY) stage 2.5-4 during medication "OFF" * Subjects must meet one of the following: 1. Never underwent DBS surgery and suitable for bilateral STN or GPi DBS surgery; 2. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold | about one month each after randomization | 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. |
Countries
China
Contacts
CONTACTJianguang Sun
CONTACTQihang Shi
Outcome results
None listed