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

May 4, 2025 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

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

46

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 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with Parkinson's Disease who underwent GPI DBS.

Description

Inclusion criteria: (1) idiopathic PD, according to the MDS Parkinson's Disease Society Diagnostic Criteria17; (2) bilateral GPi-DBS implant according to a careful consideration of patients' symptom profiles (e.g., existence and severity of dyskinesia, dystonia, axial symptoms, or cognitive and mood problems); (3) onset of PD at or before 70 years of age; and (4) disease duration of more than 3 years at the time of surgery.

Patients were excluded if they had unstable vital signs or medical and psychiatric comorbidities at the time of the study.

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 Timed Up and Go Test
Time Frame: baseline, 12 month
baseline, 12 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of the score in GFQ
Time Frame: baseline, 12 month
baseline, 12 month
Change of the score in FoG total time of TUG test
Time Frame: baseline, 12 month
baseline, 12 month
Change of the score in FoG Episodes of TUG test
Time Frame: baseline, 12 month
baseline, 12 month
Change of the score in Proportion of FoG of TUG test
Time Frame: baseline, 12 month
baseline, 12 month
Change of the score in Longest FoG duration of TUG test
Time Frame: baseline, 12 month
baseline, 12 month

Other Outcome Measures

Outcome Measure
Time Frame
Change of the scores in MDS-UPDRS
Time Frame: baseline, 12 month
baseline, 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)

November 1, 2015

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

May 1, 2025

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)

May 7, 2025

Last Update Submitted That Met QC Criteria

May 4, 2025

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPIFOG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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