Adaptive DBS for PD RCT
SMART-DBS
Adaptive vs Conventional Deep Brain Stimulation for Parkinson's Disease: A Multi-center Randomized Controlled Trial
1 other identifier
interventional
60
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2026
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 16, 2026
CompletedFirst Submitted
Initial submission to the registry
June 3, 2026
CompletedFirst Posted
Study publicly available on registry
June 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
June 9, 2026
June 1, 2026
1 year
June 3, 2026
June 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (12)
Motor-sleep dairy
about one month after randomization
MDS UPDRS
about one month after randomization
PDSS-2
about one month after randomization
- +9 more other outcomes
Study Arms (2)
Group A
EXPERIMENTALParticipants in this group will first take conventional DBS treatment for 30-45 days, then change to adaptive DBS treatment for another 30-45 days.
Group B
EXPERIMENTALParticipants in this group will first take adaptive DBS treatment for 30-45 days, then change to conventional DBS treatment for another 30-45 days.
Interventions
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.
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Pins Medical Co., Ltdlead
- Beijing Tiantan Hospitalcollaborator
- Xuanwu Hospital, Beijingcollaborator
- Nanjing Brain Hospitalcollaborator
- Qilu Hospital of Shandong Universitycollaborator
- West China Hospitalcollaborator
- Peking Union Medical College Hospitalcollaborator
- Xiangya Hospital of Central South Universitycollaborator
- First Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- The First Affiliated Hospital of USTC (Anhui Provincial Hospital)collaborator
Study Sites (9)
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei, Anhui, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 10000, China
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 10000, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2026
First Posted
June 9, 2026
Study Start
May 16, 2026
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
June 9, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share