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

March 10, 2020 updated by: Haiyan Zhou, Ruijin Hospital

Long Term Study of Subthalamic Deep Brain Stimulation for Parkinson's Disease

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Parkinson's Disease who underwent STN DBS for above 10 years or Patients with Parkinson's Disease whose disease duration longer than 15 years.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
STN DBS
Parkinson's disease (PD) patients who underwent deep brain stimulation (DBS) of the subthalamic nucleus (STN)
CONTROL
Parkinson's disease (PD) patients received optimized medical treatment according to published evidence based guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changs in the score of Stand-Walk-Sit Test
Time Frame: above 10 years post surgery
above 10 years post surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of the score in United Parkinson Disease Rating Scale (UPDRS) part III
Time Frame: above 10 years post surgery
above 10 years post surgery
UPDRS part I score
Time Frame: above 10 years post surgery
above 10 years post surgery
UPDRS part II score
Time Frame: above 10 years post surgery
above 10 years post surgery
UPDRS part IV score
Time Frame: above 10 years post surgery
above 10 years post surgery
39-Item Parkinson´s Disease Questionnaire (PDQ-39) score
Time Frame: above 10 years post surgery
above 10 years post surgery
Freezing of Gait Questionnaire (FOG-Q) score
Time Frame: above 10 years post surgery
above 10 years post surgery
Gait and Falls Questionnaire (GFQ) score
Time Frame: above 10 years post surgery
above 10 years post surgery
Mini-Mental State Examination (MMSE) score
Time Frame: above 10 years post surgery
above 10 years post surgery
Montreal Cognitive Assessment (MoCA) Beijing score Version
Time Frame: above 10 years post surgery
above 10 years post surgery
Frontal Assessment Battery (FAB) score
Time Frame: above 10 years post surgery
above 10 years post surgery
Hamilton Anxiety Scale (HAMA) score
Time Frame: above 10 years post surgery
above 10 years post surgery
Hamilton Depression Scale-17 (HAMD-17) score
Time Frame: above 10 years post surgery
above 10 years post surgery
Apathy Evaluation Scale score
Time Frame: above 10 years post surgery
above 10 years post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Investigators

  • Principal Investigator: Haiyan Zhou, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Principal Investigator: Dianyou Li, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Principal Investigator: Bomin Sun, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Principal Investigator: Wei Hu, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2017

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

July 24, 2017

First Submitted That Met QC Criteria

July 24, 2017

First Posted (Actual)

July 26, 2017

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 10, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FOGSTN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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