Adaptive DBS for PD

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.

Conditions

• Parkinson Disease(PD)

Interventions

DEVICE

adaptive deep brain stimulation

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.

DEVICE

conventional deep brain stimulation

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.

Sponsors & Collaborators

• Beijing Tiantan Hospital

  collaborator OTHER

• Xuanwu Hospital, Beijing

  collaborator OTHER

• Nanjing Brain Hospital

  collaborator UNKNOWN

• Qilu Hospital of Shandong University

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)

  collaborator OTHER

• Peking Union Medical College Hospital

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Beijing Pins Medical Co., Ltd

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-16

Primary Completion

2027-05-31

Completion

2027-09-30

Countries

• China

Study Locations