Effects of Bilateral GPI DBS on Freezing of Gait in PD (PD GPI DBS)

March 10, 2020 updated by: Haiyan Zhou

Effects of Bilateral Pallidal Deep Brain Stimulation on Freezing of Gait in Parkinson's Diseases

This study aims to evaluate the effect of deep brain stimulation in the the globus pallidus (Gpi) on freezing of gait in patients with Parkinson's disease.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

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

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:

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 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Parkinson's Disease who had freezing of gait and underwent GPI DBS.

Description

Inclusion Criteria:

  • Age >18 years of age,male or female patients
  • Idiopathic Parkinson's disease with freezing of gait
  • Had GPI deep brain stimulation implant

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
GPI DBS
patients who had freezing of gait and underwent deep brain stimulation (DBS) of the globus pallidus interna (GPi)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changs in the score of Stand-Walk-Sit Test
Time Frame: baseline, 3month, 6month, 9month, 12 month
baseline, 3month, 6month, 9month, 12 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of the scores in UPDRS
Time Frame: baseline, 3month, 6month, 9month, 12 month
baseline, 3month, 6month, 9month, 12 month
Change of the score in PDQ-39
Time Frame: baseline, 3month, 6month, 9month, 12 month
baseline, 3month, 6month, 9month, 12 month
Change of the score in the Freezing of Gait Questionnaire (FOG-Q)
Time Frame: baseline, 3month, 6month, 9month, 12 month
baseline, 3month, 6month, 9month, 12 month
Change of the score in the Gait and Falls Questionnaire (GFQ)
Time Frame: baseline, 3month, 6month, 9month, 12 month
baseline, 3month, 6month, 9month, 12 month
Change of the score in the Mini-Mental State Examination (MMSE)
Time Frame: baseline, 3month, 6month, 9month, 12 month
baseline, 3month, 6month, 9month, 12 month
Change of the score in the Montreal Cognitive Assessment (MoCA) Beijing Version
Time Frame: baseline, 3month, 6month, 9month, 12 month
baseline, 3month, 6month, 9month, 12 month
Change of the score in the Frontal Assessment Battery (FAB)
Time Frame: baseline, 3month, 6month, 9month, 12 month
baseline, 3month, 6month, 9month, 12 month

Collaborators and Investigators

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

Sponsor

Haiyan Zhou

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
  • Principal Investigator: Shengdi Chen, Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

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 (Anticipated)

July 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

July 20, 2017

First Submitted That Met QC Criteria

July 20, 2017

First Posted (Actual)

July 24, 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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPIFOG

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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