Clinical trial NCT02071693: 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
Official title: Cholinergic Pathways Hyperintensities Scale Could Not Predict the Change of Cognitive Status of Parkinson's Disease Patients After Bilateral STN DBS.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: subthalamic nucleus
deep brain stimulation
cognition
white matter hyperintensities
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2014-02-26
Enrollment: 38
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PD patients treated with bilateral STN DBS in the First Affiliated Hospital during the year of 2008-2012.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of MoCA score during follow-up and its relationship with preoperative CHIPS score
timeFrame: Pre-operation and 6, 12, 24 months post-operation
measure: Change of MMSE score during follow-up and its relationship with preoperative CHIPS score
timeFrame: Pre-operation and 6, 12, 24 months post-operation
Secondary outcomes:
measure: Change of UPDRS III score during follow-up and its relationship with preoperative CHIPS score
timeFrame: Pre-operation and 6, 12, 24 months post-operation
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Ling Chen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: