Adaptive DBS for PD RCT (SMART-DBS)

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease(PD)
• Intervention / Treatment: Device: adaptive deep brain stimulation; Device: conventional deep brain stimulation

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).

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianguang Sun; Phone Number: +86 010-60736388; Email: sunjianguang@pinsmedical.com
• Study Contact Backup: Name: Qihang Shi; Phone Number: +86 18511837185; Email: shiqihang@pinsmedical.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Not yet recruiting
      • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
      • Principal Investigator: Chaoshi Niu
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Not yet recruiting
      • Peking Union Medical College Hospital
      • Principal Investigator: Yi Guo
    • Beijing, Beijing Municipality, China, 10000
      • Recruiting
      • Beijing Tiantan Hospital, Capital Medical University
      • Principal Investigator: Jianguo Zhang
      • Contact: Hutao Xie; Phone Number: +86 18756921517
    • Beijing, Beijing Municipality, China, 10000
      • Recruiting
      • Xuanwu Hospital, Capital Medical University
      • Contact: Kailiang Wang; Phone Number: +86 13521539544
      • Principal Investigator: Guoguang Zhao
  • Guangdong
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • First Affiliated Hospital, Sun Yat-Sen University
      • Principal Investigator: Jinsheng Zeng
      • Sub-Investigator: Ling Chen
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Xiangya Hospital of Central South University
      • Principal Investigator: Zhiquan Yang
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Nanjing Brain Hospital
      • Contact: Chang Qiu
      • Principal Investigator: Wenbin Zhang
  • Shandong
    • Jinan, Shandong, China
      • Not yet recruiting
      • Qilu Hospital of Shandong University
      • Principal Investigator: Weiguo Li
  • Sichuan
    • Chengdu, Sichuan, China
      • Not yet recruiting
      • West China Hospital
      • Principal Investigator: Wei Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Participants in this group will first take conventional DBS treatment for 30-45 days, then change to adaptive DBS treatment for another 30-45 days.	Device: adaptive 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.; Other Names: aDBS; adaptive DBS; closed-loop deep brain stimulation; Device: conventional 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.; Other Names: cDBS; traditional deep brain stimulation; conventional DBS; open-loop DBS
Experimental: Group B; Participants in this group will first take adaptive DBS treatment for 30-45 days, then change to conventional DBS treatment for another 30-45 days.	Device: adaptive 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.; Other Names: aDBS; adaptive DBS; closed-loop deep brain stimulation; Device: conventional 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.; Other Names: cDBS; traditional deep brain stimulation; conventional DBS; open-loop DBS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold	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.	about one month each after randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor-sleep dairy	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 Motor-sleep Diary also collects a visual analogue scale that subjects use to evaluate overall quality of sleep last night. 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 the cDBS treatment and aDBS treatment during crossover evaluation phases. Motor-sleep Diary collects 5 measurements: daily "On" time without troublesome dyskinesia; daily "On" time with troublesome dyskinesia; daily "Off" time; daily asleep time; quality of sleep The result of 2 type of treatments and baseline will be compared.	about one month after randomization
MDS UPDRS	The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) contains 4 parts. Each measures different perspective of motor disorder. In this trial, 5 measurements will be collected: MDS UPDRS part I; MDS UPDRS part II ("best" condition); MDS UPDRS part II ("worst" condition); MDS UPDRS part III; MDS UPDRS part IV Each measurements will be collected at cDBS treatment and aDBS treatment during crossover phases. The result of each treatment will be compared.	about one month after randomization
PDSS-2	Parkinson's Disease Sleep Scale 2(PDSS-2) measures the quality of sleep of Parkinson's Disease. Measurement will be collected at cDBS treatment and aDBS treatment during crossover phases. The result of each treatment will be compared.	about one month after randomization
PSQI	Pittsburgh sleep quality index(PSQI) measures the quality of sleep. Measurement will be collected at cDBS treatment and aDBS treatment during crossover phases. The result of each treatment will be compared.	about one month after randomization
PDQ-39	Parkinson's Disease Questionnaire-39(PDQ-39) measures the quality of life of Parkinson's Disease. Measurement will be collected at cDBS treatment and aDBS treatment during crossover phases and 2 follow-up visits after crossover. The result of each treatment will be compared. Overall result will be analyzed descriptively.	about 6 months after randomization
EQ-5D-5L	EQ-5D-5L measures the quality of life. Measurement will be collected at cDBS treatment and aDBS treatment during crossover phases and 2 follow-up visits after crossover. The result of each treatment will be compared. Overall result will be analyzed descriptively.	about 6 months after randomization
Patient Preference Questionnaire	Patient Preference Questionnaire measures the preference to each treatments while blinded. Measurement will be collected at the end of last crossover phase before unblinding. The result of each treatment will be compared and analyzed descriptively.	about 2 months after randomization
Patient Satisfaction Questionnaire	Patient Satisfaction Questionnaire measures the satisfaction with each treatments. Measurement will be collected at the end of entire trial before completion. The result of each treatment will be compared and analyzed descriptively.	about 6 months after randomization
Recharging DBS Experience	Recharging DBS Experience measures the experience of subject recharge DBS device under each treatment. It is evaluated by recharging interval and accumulation of electric energy depletion. The numeric results are calculated using DBS recharging dairy embedded in the device. The more frequently recharge or the more electric energy is depleted, the poor experience the subjects have. The measurements will be collected for each treatment during crossover phase and will be compared.	about one month after randomization
TEED	Total Electric Energy Delivered(TEED) measures the amount of energy consumed by stimulation for each treatment. The numeric result are estimated by DBS stimulation parameters. The measurements will be collected for each treatment during crossover phase and will be compared.	about one month after randomization
Peripheral Device Measurements	Peripheral device measurements include motor and sleep metrics that can offer extra symptom analysis. The measurements will be collected for each treatment during crossover phase and will be compared.	about one month after randomization
GIC	The Global Impression Change Score(GIC) measure the acceptance of each treatment after programming compared to the previous treatment. It is evaluated by subject using effectiveness and side effect to acquire a status code that can be analyzed descriptively. The measurements will be collected for each treatment during adjustment phase and will be compared.	about 14 days after programming during adjustment phase

Collaborators and Investigators

• Sponsor: Beijing Pins Medical Co., Ltd
• Collaborators: Xiangya Hospital of Central South University; Peking Union Medical College Hospital; Beijing Tiantan Hospital; First Affiliated Hospital, Sun Yat-Sen University; West China Hospital; Qilu Hospital of Shandong University; Xuanwu Hospital, Beijing; The First Affiliated Hospital of USTC (Anhui Provincial Hospital); Nanjing Brain Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Parkinson Disease; Deep brain stimulation; Dyskinesia; Adaptive DBS; Close-loop DBS
• Additional Relevant MeSH Terms: Synucleinopathies; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Dyskinesias; Parkinson Disease
• Other Study ID Numbers: G1010R&PINS-C2-01-53

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No