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Study for Perioperative Neurocognitive Disorders After Deep Brain Stimulation Surgery for Parkinson's Disease

Sponsor
wenbinlu (Other)
Overall Status
Recruiting
CT.gov ID
NCT04696978
Collaborator
(none)
300
Enrollment
1
Location
28
Anticipated Duration (Months)
10.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Metabonomics Characteristics and Predictive Value for Perioperative Neurocognitive Disorders After Deep Brain Stimulation Surgery for Parkinson's Disease
    Actual Study Start Date :
    Aug 1, 2020
    Anticipated Primary Completion Date :
    Aug 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. the level of metabolomics in patients' blood sample [baseline]

    2. the level of metabolomics in patients' blood sample [24 hours after operation]

    3. the level of metabolomics in patients' blood sample [72 hours after operation]

    Secondary Outcome Measures

    1. CAM-ICU score [baseline]

    2. CAM-ICU score [24 hours after operation]

    3. CAM-ICU score [72 hours after operation]

    4. CAM-ICU score [1 month after operation]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Parkinson's patients undergoing elective deep brain stimulation

    • Age ≥55 years

    • ASA physical statusⅠ-Ⅲ

    • Elementary school or above

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Changhai Hospital, Second Military Medical University Shanghai Shanghai China

    Sponsors and Collaborators

    • wenbinlu

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    wenbinlu, Principal Investigator, Changhai Hospital
    ClinicalTrials.gov Identifier:
    NCT04696978
    Other Study ID Numbers:
    • PND-PD
    First Posted:
    Jan 6, 2021
    Last Update Posted:
    Jan 6, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Parkinson Disease
    Neurocognitive Disorders

    Study Results

    No Results Posted as of Jan 6, 2021