NCT02071693

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 1, 2014

Status Verified

March 1, 2014

Enrollment Period

3 months

First QC Date

February 23, 2014

Last Update Submit

March 28, 2014

Conditions

Parkinson's Disease

Keywords

subthalamic nucleusdeep brain stimulationcognitionwhite matter hyperintensities

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Change of UPDRS III score during follow-up and its relationship with preoperative CHIPS score

    Pre-operation and 6, 12, 24 months post-operation

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

PD patients treated with bilateral STN DBS in the First Affiliated Hospital during the year of 2008-2012.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Ling Chen, MD,PhD

    First Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

February 23, 2014

First Posted

February 26, 2014

Study Start

December 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

April 1, 2014

Record last verified: 2014-03

Locations

CN(1)