NCT03227250

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

May 7, 2025

Status Verified

March 1, 2020

Enrollment Period

4.2 years

First QC Date

July 20, 2017

Last Update Submit

May 4, 2025

Conditions

Parkinson Disease

Keywords

freezing of gaitParkinson diseaseGPi

Outcome Measures

Primary Outcomes (1)

  • Changs in the score of Timed Up and Go Test

    baseline, 12 month

Secondary Outcomes (5)

  • Change of the score in GFQ

    baseline, 12 month

  • Change of the score in FoG total time of TUG test

    baseline, 12 month

  • Change of the score in FoG Episodes of TUG test

    baseline, 12 month

  • Change of the score in Proportion of FoG of TUG test

    baseline, 12 month

  • Change of the score in Longest FoG duration of TUG test

    baseline, 12 month

Other Outcomes (1)

  • Change of the scores in MDS-UPDRS

    baseline, 12 month

Study Arms (1)

GPI DBS

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Parkinson's Disease who underwent GPI DBS.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Haiyan Zhou

    Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

  • Shengdi Chen

    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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
attending neurologist

Study Record Dates

First Submitted

July 20, 2017

First Posted

July 24, 2017

Study Start

November 1, 2015

Primary Completion

January 1, 2020

Study Completion

May 1, 2025

Last Updated

May 7, 2025

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)