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Effectiveness and Safety of Directional Deep Brain Stimulation for Parkinson's Disease | Clinical Trials | Clareo Health

COMPLETEDNA

Effectiveness and Safety of Directional Deep Brain Stimulation for Parkinson's Disease

NCT05992701•Beijing Pins Medical Co., Ltd

View on ClinicalTrials.gov

Summary

The purpose of this study is to demonstrate the safety and effectiveness of the PINS Deep Brain Stimulation (DBS) system, including the G107R/G107 IPG, L305/L306 directional leads, E204 extensions and related system components.

Detailed Description

This is a prospective, open label, non-randomized study. The study will evaluate the clinical outcome and possible adverse effects of the directional DBS treatment. The following data will be collected: therapeutic window, Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III scores, Parkinson's Disease Questionnaire (PDQ-39) summary scores, total electrical energy delivered, the dosage of anti-parkinsonian medications, on time(h/d) without troublesome dyskinesia, and adverse events.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age at the time of enrollment: 18 \~ 75;
•2. Idiopathic Parkinson's disease;
•3. Patient whose symptoms are not adequately controlled by best medical therapy;
•4. Hoehn and Yahr stage≥2.5;
•5. Patient whose symptoms are improved by at least 30% with levodopa challenge test;
•6. Must be an appropriate candidate for the surgical procedures required for bilateral DBS;
•7. Is willing and able to comply with all visits and study related procedures;
•8. Patient understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.

Exclusion Criteria

•1. Had received lesioning surgical treatment;
•2. A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception;
•3. Any current drug or alcohol abuse;
•4. Cognitive impairment (MMSE≦17 for primary school education or MMSE≦24 for middle school education and above);
•5. Any significant psychiatric problems, including unrelated clinically significant depression;
•6. Any history of craniocerebral injury, tumor, or severe cerebrovascular disease;
•7. Severe brain atrophy (confirmed by CT or MRI);
•8. A condition requiring or likely to require the use of diathermy;
•9. Abnormal blood routine or biochemical test, coagulation dysfunction, serious abnormal liver or kidney function;
•10. Uncontrolled high blood pressure, serious heart disease or serious medical or respiratory diseases;
+7 more criteria

Locations (9)

Beijing Tiantan Hospital, Capital Medical University

Beijing, China

Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University

Beijing, China

West China Hospital of Sichuan University

Chengdu, China

First Affiliated Hospital of Kunming Medical University

Kunming, China

Nanjing Brain Hospital Affiliated to Nanjing Medical University

Nanjing, China

Changhai Hospital, the Second Military Medical University

Shanghai, China

Shenzhen Second People's Hospital (the First Affiliated Hospital of Shenzhen University)

Shenzhen, China

Tianjin Medical University General Hospital

Tianjin, China

Zhongnan Hospital of Wuhan University

Wuhan, China

Key Dates

Start Date

July 28, 2021

Primary Completion Date

November 13, 2023

Completion Date

December 23, 2023

Last Updated

December 10, 2025

Enrollment

ACTUAL participants

Conditions

Parkinson's Disease

Interventions

Directional deep brain stimualtion

DEVICE

Deep Brain Stimulation Therapy in Movement Disorders

NCT02119611

Parkinson's Disease

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RECRUITINGPHASE1

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

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RECRUITINGNA

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effectiveness and Safety of Directional Deep Brain Stimulation for Parkinson's Disease

Inclusion Criteria

Exclusion Criteria

Deep Brain Stimulation Therapy in Movement Disorders

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

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