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

Completed

• Conditions: Parkinson's Disease

• Registration Number: NCT01953718
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-09-26
• Study First Submitted QC: 2013-09-26
• Status Verified: 2013-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Study First Posted: 2013-10-01
• Last Update Submitted: 2013-10-09
• Last Update Posted: 2013-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change of daily levodopa equivalent dosage (LED) during follow-up	at 12 months

Trial Locations

Locations (1)

First Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China