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NCT Number: NCT07635823

Adaptive DBS for PD

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.

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Key information

Conditions

Parkinson Disease(PD) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dyskinesias Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of USTC (Anhui Provincial Hospital), Hefei, Anhui, China

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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

Treatment and study plan

adaptive deep brain stimulation

Device

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: closed-loop deep brain stimulation, aDBS, adaptive DBS

conventional deep brain stimulation

Device

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

Primary outcomes

  1. Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold

    Time frame: 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.

Other outcomes

  1. Motor-sleep dairy

    Time frame: about one month 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 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.

  2. MDS UPDRS

    Time frame: about one month after randomization

    The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) contains 4 parts. Each parts range as the following: 0~52, 0~52, 0~132, 0~24. Lower score means better rating on the according symptoms. 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.

  3. PDSS-2

    Time frame: about one month after randomization

    Parkinson's Disease Sleep Scale 2(PDSS-2) measures the quality of sleep of Parkinson's Disease. The scale ranges from 0 to 60. Lower score means better rating on sleep conditions. Measurement will be collected at cDBS treatment and aDBS treatment during crossover phases. The result of each treatment will be compared.

  4. PSQI

    Time frame: about one month after randomization

    Pittsburgh sleep quality index(PSQI) measures the quality of sleep. The scale ranges from 0 to 21. Lower score means better rating on 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.

  5. PDQ-39

    Time frame: about 6 months after randomization

    Parkinson's Disease Questionnaire-39(PDQ-39) measures the quality of life of Parkinson's Disease, containing 39 items that range from 0 to 4. The final score is computed through the following steps: 1. calculate the average score of every item in 8 dimensions and span the results to a range from 0 to 100; 2. calculate the average score of all dimensions. The final score ranges from 0 to 100. Lower score means better rating on 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.

  6. EQ-5D-5L

    Time frame: about 6 months after randomization

    EQ-5D-5L measures the quality of life, containing 5 questions and 1 visual analogue scale(VAS) for rating of subjective conclusive quality of life. The results of 5 questions form a state code of 5 digits. The state code will be transformed to EQ-5D index score using a values set for China. Measurements will be collected at cDBS treatment and aDBS treatment during crossover phases and 2 follow-up visits after crossover. The results of each treatment will be compared. Overall result will be analyzed descriptively.

  7. Patient Preference Questionnaire

    Time frame: about 2 months after randomization

    Patient Preference Questionnaire measures the preference to each treatments while blinded. The questionnaire contains 6 independent questions. Each option of every question will be counted as a percentage. Measurement will be collected at the end of last crossover phase before unblinding. The result of each treatment will be compared and analyzed descriptively.

  8. Patient Satisfaction Questionnaire

    Time frame: about 6 months after randomization

    Patient Satisfaction Questionnaire measures the satisfaction with each treatments. The questionnaire contains 3 independent questions. Each option of every question will be counted as a percentage. Measurement will be collected at the end of entire trial before completion. The result of each treatment will be compared and analyzed descriptively.

  9. Recharging DBS Experience

    Time frame: about one month after randomization

    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.

  10. TEED

    Time frame: about one month after randomization

    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.

  11. Peripheral Device Measurements

    Time frame: about one month after randomization

    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.

  12. GIC

    Time frame: about 14 days after programming during adjustment phase

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jianguang Sun

CONTACT

[email protected]

+86 010-60736388

Qihang Shi

CONTACT

[email protected]

+86 18511837185

Sponsors and collaborators

Lead sponsor

Beijing Pins Medical Co., Ltd

Industry

Collaborators

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

Registry information

Official study title

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

Acronym: SMART-DBS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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