A Retrospective Study of the Effects of Different Paramet... | NCT01953718

Studies
A Retrospective Study of the Effects of Different Parameters on Motor Symptoms of PD in Bilateral STN Stimulation

NCT01953718

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Status

Completed

Last Update Posted

Oct 10, 2013Estimated

Enrollment

27Actual

Phase

Not provided

Conditions

Parkinson's 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

ID	Type	Description	Link
10151008901000187	Other Grant/Funding Number	GNSF

Status Module

Record Verification Date

Oct 2013

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

Jul 2013

Primary Completion Date

Oct 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Sep 26, 2013

First Submission Date that Met QC Criteria

Sep 26, 2013

First Posted Date

Oct 1, 2013Estimated

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

Oct 9, 2013

Last Update Posted Date

Oct 10, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chen Ling, MD,PhD, First Affiliated Hospital, Sun Yat-Sen UniversityPrincipal Investigator

Lead Sponsor

First Affiliated Hospital, Sun Yat-Sen UniversityOTHER

Collaborators

Not provided

Description Module

Brief Summary

The purpose of this study is to assess the impact of different parameters (voltage, pulse width, frequency) of subthalamic nucleus (STN) deep brain stimulation (DBS) on motor symptoms in patients with Parkinson's disease (PD).

Detailed Description

In this observational study, we will retrospectively analyze the one-year follow-up data of 27 PD patients who received bilateral STN DBS in the First Affiliated Hospital of Sun Yat-sen University in the years 2008-2012. The data, including parameter settings and severity of motor symptoms indicated by Unified Parkinson's Disease Rating Scale (UPDRS) Part III scores, was collected during the patients' annual visit to the hospital for reprogramming. A correlation analysis will be conducted to investigate the relationship between change of a specific parameter and the subsequent change of motor scores.

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

27Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of parameters (voltage, pulse width, frequency) during follow-up		at 12 months
Change of UPDRS Part III score and the relation to parameters		at 12 months
Changes of tremor, rigidity, bradykinesia and postural stability scores evaluated by UPDRS Part III and the relation to parameters		at 12 months

Secondary Outcomes

Measure	Description	Time Frame
Change of daily levodopa equivalent dosage (LED) during follow-up		at 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

PD patients treated with bilateral STN DBS in the First Affiliated Hospital in the years 2008-2012

Exclusion Criteria:

Simultaneous participation in another clinical trial
Dementia (Mini Mental State Examination < 26)
Removal of DBS electrodes
Loss to follow-up

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

PD patients who received bilateral STN DBS in the First Affiliated Hospital of Sun Yat-sen University

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Affiliated Hospital, Sun Yat-sen University		Guangzhou	Guangdong	510080	China

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

Not provided

Browse Branches

Not provided