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Study on the Efficacy and Safety of Rechargeable Implantable DBS System in the Treatment of Parkinson's Disease

NCT05997667 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-08-18

No results posted yet for this study

Summary

The purpose of this clinical trial is to verify the efficacy and safety of rechargeable implantable deep brain stimulation (DBS) system for the treatment of advanced primary Parkinson's disease.

Conditions

  • Parkinson Disease

Interventions

DEVICE

Rechargeable implantable deep brain stimulation system

The DBS system will be implanted in subjects in both study arms. Subjects in experimental group will receive stimulation of DBS system within 1 month after surgery.

DEVICE

Rechargeable implantable deep brain stimulation system

The DBS system will be implanted in subjects in both study arms. Subjects in control group will receive stimulation of DBS system at 3 months after surgery.

Sponsors & Collaborators

  • Lepu Medical Technology (Beijing) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-20
Primary Completion
2025-01-20
Completion
2025-07-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05997667 on ClinicalTrials.gov