Follow Up Study for Treatment of Parkinson's Disease With Subthalamic Deep Brain Stimulation

NCT ID: NCT03230331

Last Updated: 2020-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-24

Study Completion Date

2019-05-01

Brief Summary

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This study aims to evaluate the long term effect of deep brain stimulation in the the subthalamic nucleus (STN) in patients with Parkinson's disease.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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STN DBS

Parkinson's disease (PD) patients who underwent deep brain stimulation (DBS) of the subthalamic nucleus (STN)

No interventions assigned to this group

CONTROL

Parkinson's disease (PD) patients received optimized medical treatment according to published evidence based guidelines

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Idiopathic Parkinson's disease
* Disease duration longer than 15 years
* Had STN deep brain stimulation implant more than 10 years
* Available and willing to be followed-up according to study protocol

Exclusion Criteria

* Patients with serious diseases such as tumor, sever liver or kidney dysfunction were not selected in the clinical trials
* Epilepsy
* Pregnant female
* History of severe neuropsychiatric disease
* Patients are taking part in other clinical trials in recent several months
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Haiyan Zhou

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haiyan Zhou

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Dianyou Li

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Bomin Sun

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Wei Hu

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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FOGSTN

Identifier Type: -

Identifier Source: org_study_id

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