Study for Perioperative Neurocognitive Disorders After Deep Brain Stimulation Surgery for Parkinson's Disease
Metabonomics Characteristics and Predictive Value for Perioperative Neurocognitive Disorders After Deep Brain Stimulation Surgery for Parkinson's Disease
1 other identifier
observational
300
1 country
1
Brief Summary
Perioperative neurocognitive disorders(PND) is common to see in elderly patients. Although PND increases patient mortality as well as hospitalization time, apparent inflammatory factors, and related mechanisms are still unknown. Metabolites could reveal chemical fingerprints left behind by cellular processes, which in turn provide a new aspect to understand the biological process behind. we aim to found the metabolomics can aid the development of diagnostic markers of PND screening, early detection, and further, provide a basis for disease prevention and treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2020
CompletedFirst Submitted
Initial submission to the registry
December 23, 2020
CompletedFirst Posted
Study publicly available on registry
January 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJanuary 6, 2021
January 1, 2021
2 years
December 23, 2020
January 5, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
the level of metabolomics in patients' blood sample
baseline
the level of metabolomics in patients' blood sample
24 hours after operation
the level of metabolomics in patients' blood sample
72 hours after operation
Secondary Outcomes (4)
CAM-ICU score
baseline
CAM-ICU score
24 hours after operation
CAM-ICU score
72 hours after operation
CAM-ICU score
1 month after operation
Study Arms (2)
PND group
patients occur neurocognitive disorders according to scores in this group
NO PND group
patients do not occur neurocognitive disorders according to scores in this group
Eligibility Criteria
we select Parkinson's patients undergoing elective DBS and observe who occur PND or not.
You may qualify if:
- Parkinson's patients undergoing elective deep brain stimulation
- Age ≥55 years
- ASA physical statusⅠ-Ⅲ
- Elementary school or above
You may not qualify if:
- patients with ASA physical status\>III
- patients with systemic immune diseases, hematological diseases (hematological tumors or leukemia), patients after transplantation, malignant tumors
- patients with metabolic diseases such as diabetes, ketoacidosis, hyperosmolar syndrome, long-term hypoglycemia,gout
- patients who refused to join the study and lost to follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- wenbinlulead
Study Sites (1)
Changhai Hospital, Second Military Medical University
Shanghai, Shanghai Municipality, China
Biospecimen
blood of patients is collected in normal patients and PND patients
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Month
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 23, 2020
First Posted
January 6, 2021
Study Start
August 1, 2020
Primary Completion
August 1, 2022
Study Completion
December 1, 2022
Last Updated
January 6, 2021
Record last verified: 2021-01