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

Neurocognitive Disorders Clinical Trial

Official title:

Metabonomics Characteristics and Predictive Value for Perioperative Neurocognitive Disorders After Deep Brain Stimulation Surgery for Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04696978
• Other study ID #: PND-PD
• Status: Recruiting
• Start date: August 1, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: January 2021
• Source: Changhai Hospital
• Contact: wenbin lu
• Phone: 13004162573
• Email: 13004162573[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Parkinson's patients undergoing elective deep brain stimulation

• Age =55 years

• ASA physical status?-?

• 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

Related Conditions & MeSH terms

• Neurocognitive Disorders
• Parkinson Disease

Locations

Country	Name	City	State
China	Changhai Hospital, Second Military Medical University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
wenbinlu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the level of metabolomics in patients' blood sample		baseline
Primary	the level of metabolomics in patients' blood sample		24 hours after operation
Primary	the level of metabolomics in patients' blood sample		72 hours after operation
Secondary	CAM-ICU score		baseline
Secondary	CAM-ICU score		24 hours after operation
Secondary	CAM-ICU score		72 hours after operation
Secondary	CAM-ICU score		1 month after operation