Adaptive DBS for Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, double‑blind crossover study compares an adaptive closed-loop DBS system (aDBS) using real-time brain signals and sleep data to conventional open-loop DBS in people with Parkinson’s disease. Participants will receive a PINS Medical G1010R neurostimulator implant and experience both stimulation modes in alternating phases. Outcomes include dyskinesia duration, off time, motor symptoms, sleep quality, and overall quality of life, with safety monitoring throughout. The trial comprises screening, surgery, DBS optimization for both modalities, crossover evaluation, and long‑term follow-up across multiple visits.

Why it matters

Who can join: the full rules

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

Where it's running

• Beijing Tiantan Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Xuanwu Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Xiangya Hospital of Central South University
  Changsha, Hunan, China Recruiting
• Nanjing Brain Hospital
  Nanjing, Jiangsu, China Recruiting
• The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
  Hefei, Anhui, China Not yet recruiting
• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Jianguang Sun
• Email: sunjianguang@pinsmedical.com
• Phone: +86 010-60736388

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using DANU smart socks to measure walking, balance, and fall risk in Parkinson's

  This project will test whether DANU smart socks can accurately measure gait and balance and help predict falls in people with Parkinson's.

  Recruiting Northumbria University · Newcastle upon Tyne · NCT07281755

• Boosting empathy and self-compassion for people with Parkinson's and their caregivers

  This project will try a six-week empathy and self-compassion training to see if it improves quality of life for people with Parkinson's and their regular caregivers.

  Recruiting Ente Ospedaliero Cantonale, Bellinzona · Lugano · NCT07097298

• Spinal cord stimulation to help post-stroke spasticity

  This study tests whether active spinal cord stimulation can reduce limb spasticity after stroke compared with a sham treatment in adults.

  Recruiting Beijing Pins Medical Co., Ltd · Beijing · NCT07744659

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.