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

Parkinson's Disease Clinical Trial

Official title:

Cholinergic Pathways Hyperintensities Scale Could Not Predict the Change of Cognitive Status of Parkinson's Disease Patients After Bilateral STN DBS.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02071693
• Other study ID #: [2008] 20
• Secondary ID: 2010B080701107
• Status: Completed
• Phase: N/A
• First received: February 23, 2014
• Last updated: March 28, 2014
• Start date: December 2013
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• 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

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

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 MoCA score during follow-up and its relationship with preoperative CHIPS score		Pre-operation and 6, 12, 24 months post-operation	No
Primary	Change of MMSE score during follow-up and its relationship with preoperative CHIPS score		Pre-operation and 6, 12, 24 months post-operation	No
Secondary	Change of UPDRS III score during follow-up and its relationship with preoperative CHIPS score		Pre-operation and 6, 12, 24 months post-operation	No