Effects of Bilateral GPI DBS on Freezing of Gait in PD | NCT03227250

Studies
Effects of Bilateral GPI DBS on Freezing of Gait in PD

NCT03227250

Sponsor

Haiyan Zhou

Status

Completed

Last Update Posted

May 7, 2025Actual

Enrollment

46Actual

Phase

Not provided

Conditions

Parkinson Disease

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2015Actual

Primary Completion Date

Jan 1, 2020Actual

Completion Date

May 1, 2025Actual

First Submitted Date

Jul 20, 2017

First Submission Date that Met QC Criteria

Jul 20, 2017

First Posted Date

Jul 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2025

Last Update Posted Date

May 7, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changs in the score of Timed Up and Go Test		baseline, 12 month

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Measure	Description	Time Frame
Change of the scores in MDS-UPDRS		baseline, 12 month

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with Parkinson's Disease who underwent GPI DBS.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Haiyan Zhou	Ruijin Hospital	Principal Investigator
Shengdi Chen	Ruijin Hospital	Principal Investigator
Dianyou Li	Ruijin Hospital	Principal Investigator
Bomin Sun	Ruijin Hospital	Principal Investigator
Wei Hu	University of Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine		Shanghai			China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

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Browse Branches

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