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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01953718
• Other study ID #: [2008]20
• Secondary ID: 1015100890100018
• Status: Completed
• Phase: N/A
• First received: September 26, 2013
• Last updated: October 9, 2013
• Start date: July 2013
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
China	First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of parameters (voltage, pulse width, frequency) during follow-up		at 12 months	No
Primary	Change of UPDRS Part III score and the relation to parameters		at 12 months	No
Primary	Changes of tremor, rigidity, bradykinesia and postural stability scores evaluated by UPDRS Part III and the relation to parameters		at 12 months	No
Secondary	Change of daily levodopa equivalent dosage (LED) during follow-up		at 12 months	No