A Retrospective Study of the Relationship Between White Matter Hyperintensities(WMHs) Within the Cholinergic Pathways and the Cognition of PD Patients After Bilateral STN DBS

Completed

• Conditions: Parkinson's Disease

• Registration Number: NCT02071693
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Brief Summary

To retrospectively investigate the relationship between the Cholinergic Pathways Hyperintensities Scale (CHIPS) score and the change of cognitive status of Parkinson's disease (PD) patients after bilateral subthalamic nucleus deep brain stimulation (STN DBS).

Detailed Description

In this observational study, we will retrospectively analyze 38 PD patients who received bilateral STN DBS in the First Affiliated Hospital of Sun Yat-sen University during the year of 2008-2012. All patients will be evaluated by Unified Parkinson's Disease Rating Scale part III(UPDRSIII) before and after operation. Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment(MoCA) in the on medication condition pre-operation and on stimulation on medication condition post-operation. The follow-up time points are one week pre-operation and 6, 12, 24 months post-operation. Before operation, white matter hyperintensities（WMHs）in the cholinergic pathways will be determined on a 3.0 Tesla MRI, using the visual rating scale of Cholinergic Pathways Hyperintensities Scale (CHIPS). A correlation analysis will be conducted to investigate the relationship between CHIPS score and the change of cognitive status of PD patients after bilateral STN DBS retrospectively.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-02-23
• Study First Submitted QC: 2014-02-23
• Study First Posted: 2014-02-26
• Status Verified: 2014-03
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Last Update Submitted: 2014-03-28
• Last Update Posted: 2014-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Clinical diagnosis of Parkinson's disease according to United Kingdom Parkinson's Disease Brain Bank Criteria
• Experience bilateral STN DBS surgery in the First Affiliated Hospital, Sun Yat-sen University, China.
• Preoperative 3.0 Tesla MRI scanning.

Exclusion Criteria

• Loss to follow-up
• Participation in other clinical trials

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of MoCA score during follow-up and its relationship with preoperative CHIPS score	Pre-operation and 6, 12, 24 months post-operation
Change of MMSE score during follow-up and its relationship with preoperative CHIPS score	Pre-operation and 6, 12, 24 months post-operation

Secondary Outcome Measures

Name	Time	Method
Change of UPDRS III score during follow-up and its relationship with preoperative CHIPS score	Pre-operation and 6, 12, 24 months post-operation

Trial Locations

Locations (1)

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