🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Adaptive DBS for PD

RecruitingNAAges 18 Years - anyAllBeijing Pins Medical Co., Ltd
NCT07635823 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
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
💊

What it tests

  • adaptive deep brain stimulation
  • conventional deep brain stimulation
📍

Where

9 sites
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, China
Xuanwu Hospital, Capital Medical University
Beijing, China
Peking Union Medical College Hospital
Beijing, China
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, China
Xiangya Hospital of Central South University
Changsha, China
Nanjing Brain Hospital
Nanjing, China
Qilu Hospital of Shandong University
Jinan, China

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy