NCT07635823Recruiting
Adaptive DBS for PD
Adaptive vs Conventional Deep Brain Stimulation for Parkinson's Disease: A Multi-center Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 3 Jun 2026
- Start date
- 16 May 2026
- Primary completion date
- 31 May 2027
- Lead sponsor
- Beijing Pins Medical Co., Ltd
- Diseases
- Parkinson disease
- NCT number
- NCT07635823
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 16 May 2026 to the primary completion date, 31 May 2027
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of contraindications to deep brain stimulation (DBS) surgery.
- 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
- Inability to maintain prescribed medication regimens or comply with protocol requirements
- Participation in other interventional clinical trials within 4 weeks prior to consent
Other illness
- History of ablative neurosurgery or stem cell therapy for Parkinson's disease
- Other conditions deemed by investigators to compromise study suitability
Other
- Beck Depression Inventory-II (BDI-II) score \> 25
- Mini-Mental State Examination (MMSE) score \< 24 (adjusted for educational level)
- Inability to complete ≥3 consecutive days of comprehensive motor/sleep diaries
- Current pregnancy, lactation, or planned pregnancy during the study period
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Beijing Tiantan Hospital,Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Xuanwu Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| West China Hospital Coordinator of this site? Confirm its status | Chengdu | China | Not yet recruiting |
| First Affiliated Hospital, Sun Yat-Sen University Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| The First Affiliated Hospital of USTC(Anhui Provincial Hospital) Coordinator of this site? Confirm its status | Hefei | China | Not yet recruiting |
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Not yet recruiting |
| Nanjing Brain Hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.