Evidence for Cognitive Compensation Mechanism in the Postoperative Delirium: a Prospective Multi-modal Neuroimaging Cohort Study in Patients With Frontal Glioma

NCT05375409 | Unknown DMC

• 1 other identifier: Guobin Zhang
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, patients with frontal glioma will be selected for preoperative neurocognitive assessment, APOE genotype detection, 3D structural imaging, cortical blood oxygen level dependent imaging (resting state + task state), and subcortical diffusion tensor multimodal MRI to explore preoperative brain structures and brain networks, and postoperative delirium will be assessed 1-3 days after surgery. The aim was to investigate the preoperative neuroanatomical basis of postoperative delirium in this population at the level of brain structure and network connectivity, and to predict the risk of patients by integrating cognitive indicators and neuroimaging markers in an event probability model to construct an optimal sequence of abnormalities in a series of markers, and then to establish a more population-specific subgroup prediction based on different APOE genotypes and the establishment of neurological compensation. The final clinical validation was performed on a small sample to provide a basis for the prevention of postoperative delirium in frontal glioma patients.

Conditions

Postoperative Delirium

Keywords

postoperative delirium; multi-model imaging

Outcome Measures

Primary Outcomes (2)

• occurrance of postoperative delirium

  POD(+) POD(-)

  1-3day after surgery

• preoperative cognitive examination

  cognitive scores

  before sugery

Study Arms (3)

Postoperative Delirium (+)

Postoperative Delirium (-)

Healthy Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with frontal glioma on MRI of the head, age 18-60 years

You may qualify if:

• Patients with frontal glioma as revealed by head MRI, aged 18-60 years, with no history of serious disease, and who signed an informed consent form were included in the study. Controls were healthy volunteers of the same age group used for functional MRI resting state data control.

You may not qualify if:

• (1) patients who cannot cooperate with preoperative neurocognitive assessment and preoperative functional MRI; (2) patients with psychiatric disorders; (3) patients with a history of hydrocephalus, cerebral infarction, or cerebral hemorrhage; (4) patients with epilepsy and a history of antiepileptic drugs; (5) patients who have taken sedative or analgesic drugs within 24 hours of study entry; (6) patients with drug and alcohol abuse; (7) patients with perinatal and lactating conditions; (8) patients with recurrent intracranial tumors; (9) patients with multiple intracranial tumors; (10) patients who have undergone surgery for radiation or chemotherapy; (11) patients with multiple intracranial tumors. (6) patients with drug and alcohol abuse; (7) perinatal and lactating patients; (8) patients with recurrent intracranial tumors; (9) patients with multiple intracranial tumors; (10) patients who have undergone surgery with radiotherapy or chemotherapy; (10) patients with claustrophobia.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Department of Neurosugery, Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 16, 2022
• Study Start: January 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 31, 2023
• Last Updated: May 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)