Parkinson's DiseaseNCT02071693
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
An observational study of Parkinson's Disease, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson's Disease
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- Dec 2013to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PD patients treated with bilateral STN DBS in the First Affiliated Hospital during the year of 2008-2012.
Who may be able to join
- 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.
Who cannot join
- Loss to follow-up
- Participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: Cholinergic Pathways Hyperintensities Scale Could Not Predict the Change of Cognitive Status of Parkinson's Disease Patients After Bilateral STN DBS.
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).
Read the 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.
- Conditions
- Parkinson's Disease
- Keywords
- subthalamic nucleus, deep brain stimulation, cognition, white matter hyperintensities
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of MoCA score during follow-up and its relationship with preoperative CHIPS score
Measured: Pre-operation and 6, 12, 24 months post-operation
Change of MMSE score during follow-up and its relationship with preoperative CHIPS score
Measured: 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
Measured: Pre-operation and 6, 12, 24 months post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startDec 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Ling, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Ling Chen, MD,PhD, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071693
- Sponsor's protocol ID
- [2008] 20
- Other IDs
- 2010B080701107
- Status last verified
- Mar 2014
- First submitted
- 23 Feb 2014
- Last updated
- 1 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholinergic Pathways Hyperintensities Scale Could Not Predict the Change of Cognitive Status of Parkinson's Disease Patients After Bilateral STN DBS.
- ClinicalTrials.gov ID
- NCT02071693
- Acronym / sponsor ID
- [2008] 20
- Conditions
- Parkinson's Disease
- Keywords
- subthalamic nucleus, deep brain stimulation, cognition, white matter hyperintensities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 26 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PD patients treated with bilateral STN DBS in the First Affiliated Hospital during the year of 2008-2012.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Loss to follow-up
- Participation in other clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of MoCA score during follow-up and its relationship with preoperative CHIPS score
Time frame: Pre-operation and 6, 12, 24 months post-operation
Change of MMSE score during follow-up and its relationship with preoperative CHIPS score
Time frame: Pre-operation and 6, 12, 24 months post-operation
1 secondary outcome
Change of UPDRS III score during follow-up and its relationship with preoperative CHIPS score
Time frame: Pre-operation and 6, 12, 24 months post-operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ling Chen, MD,PhD principal investigator
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of MoCA score during follow-up and its relationship with preoperative CHIPS score (time frame: Pre-operation and 6, 12, 24 months post-operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2014.