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Status unknownNCT05375409Updated May 16, 2022

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

An observational study in Postoperative Delirium, sponsored by Beijing Tiantan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-16.

Sponsored by Beijing Tiantan Hospital · Observational

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 60 Years
Sex
All
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Study 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.

Read the detailed description

Delirium is an acute, reversible, widespread alteration of cognitive function characterized by fluctuating cognitive dysfunction, decreased level of consciousness, inattention, disorganized thinking, or disturbed sleep-wake cycles. Postoperative delirium is a common postoperative complication in surgical patients, occurring 1-3 days after surgery and fluctuating between 11-51% depending on the patient's age, type of surgery, and preoperative underlying disease. Postoperative delirium significantly increases perioperative complications and mortality and may leave severe long-term cognitive impairment. However, there is a relative lack of studies addressing delirium after neurosurgical craniotomy. This population may be at high risk for postoperative delirium given the direct impact of intracranial primary lesions on brain structure and function. Our team has completed a prospective cohort study (registry number: NCT03087838) enrolling 800 post-neurosurgical craniotomy patients and found for the first time that patients with gliomas had the highest incidence of postoperative delirium relative to other intracranial occupying lesions at 37.7%, especially frontal gliomas at 53.3%, and that the incidence of delirium was much higher in patients with high-grade gliomas than in patients with low The incidence of delirium was much higher in patients with high-grade gliomas than in patients with low-grade gliomas (50% vs. 16.7%) (the results of the study have not yet been published). Why is the incidence of postoperative delirium higher in patients with gliomas, especially frontal gliomas, than in other lesions, given that they are intracranial occurrences? This question caused us to think about it.

Glioma is the most common intracranial malignancy, accounting for approximately 80% of malignant brain tumors. Recent studies have found that neurocognitive dysfunction is a more common phenomenon in glioma patients and is closely associated with a decrease in health-related quality of life (HRQOL) in patients. Therefore, as the level of glioma treatment improves, patient survival is prolonged, and quality of life is increasingly emphasized, neurocognitive dysfunction has become a hot issue in the field of glioma. Postoperative delirium, as a clear and important "catalyst" for postoperative cognitive dysfunction, deserves more attention.

Given that the treatment of delirium is uncertain and that 30-40% of postoperative delirium is preventable, it is important to screen for high-risk groups. This project will explore the neuroanatomical basis of postoperative delirium in frontal glioma patients using multimodal magnetic resonance technology preoperatively, and integrate neuroimaging features and cognitive events with multidimensional clinical neurocognitive assessment to construct and validate a risk assessment model to predict postoperative delirium in this population. The significance of this study is: (1) to investigate the pathogenesis of postoperative delirium in frontal glioma patients, to explore the objective neuroimaging features with high specificity and sensitivity in vivo, and to provide new ideas and methods for the pathophysiological mechanisms of postoperative delirium; (2) the construction of the prediction model may help to provide early warning of postoperative delirium in glioma patients, which is of great clinical significance for perioperative management.

02

Conditions studied

  • Postoperative Delirium

Keywords

  • postoperative delirium
  • multi-model imaging
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In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's planned enrollment of 100 is below the median of 200 across 418 observational studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • (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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Postoperative Delirium (+)
  • Postoperative Delirium (-)
  • Healthy Control
06

What researchers measure

Primary outcomes

  1. occurrance of postoperative delirium

    POD(+) POD(-)

    Time frame: 1-3day after surgery

  2. preoperative cognitive examination

    cognitive scores

    Time frame: before sugery

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Study locations

1 of 1 sites recruiting
  • Department of Neurosugery, Beijing Tiantan Hospital
    Beijing, Beijing 100070, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05375409
Lead sponsor
Beijing Tiantan Hospital
Responsible party
Sponsor
First posted
May 16, 2022
Start date
Jan 1, 2019
Primary completion
Dec 1, 2021
Completion
Dec 31, 2023 (estimated)
Last update
May 16, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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