- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07699172
EEG-Guided Cognitive Function Preservation in Patients With Brain Tumors
A Prospective Single-Arm Study of EEG-Based Neural Signal Decoding for Cognitive Function Preservation in Patients Undergoing Brain Tumor Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a prospective, single-center, single-arm interventional study designed to investigate an EEG-based neural signal decoding strategy for higher-order cognitive function preservation in patients undergoing brain tumor surgery.
Eligible patients with brain tumors scheduled for surgical treatment will be enrolled. Participants will receive standardized neuropsychological assessments before and after surgery. High-density EEG recordings will be acquired during different stages of the perioperative period, including task-based and resting-state paradigms when applicable. Neural signal decoding methods will be used to extract cognitive-related electrophysiological features and evaluate their association with postoperative cognitive outcomes.
The primary objective is to evaluate the feasibility of EEG-based neural signal decoding for objective cognitive assessment and functional preservation during brain tumor surgery. Secondary objectives include exploring the relationship between electrophysiological biomarkers and neuropsychological performance, evaluating perioperative cognitive changes, and providing preliminary evidence for individualized cognitive protection strategies in brain tumor patients.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bo Wang
- Phone Number: 022-59065262
- Email: dr.bo.wang@tmu.edu.cn
Study Locations
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-
Tianjin Municipality
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Tianjin, Tianjin Municipality, China, 300350
- Tianjin Huanhu Hospital
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Contact:
- Bo Wang
- Phone Number: 022-59065262
- Email: dr.bo.wang@tmu.edu.cn
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 years to 75 years.
- Patients diagnosed with brain glioma and scheduled for surgical treatment.
- Conscious and able to understand study procedures.
- Able to complete neuropsychological assessments.
- Willing to participate and provide written informed consent.
Exclusion Criteria:
- Severe dysfunction of major organs (heart, lung, liver, or kidney).
- Severe psychiatric disorders or cognitive impairment.
- Severe language impairment preventing completion of study procedures.
- Any other condition judged by the investigator to make participation inappropriate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EEG-Guided Cognitive Function Preservation
Participants undergoing brain tumor surgery will receive the EEG-based neural signal decoding strategy in addition to standard surgical management for individualized cognitive function preservation.
Cognitive outcomes will be evaluated using standardized neuropsychological assessments.
|
EEG-based neural signal decoding will be performed during the perioperative period to identify cognitive functional networks and assist individualized cognitive function preservation during brain tumor surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mini-Mental State Examination (MMSE) Total Score
Time Frame: Baseline, postoperative 1 week, postoperative 1 month, and postoperative 3 months
|
Cognitive function assessed using the Mini-Mental State Examination (MMSE).
The total score ranges from 0 to 30, with higher scores indicate better cognitive function.
|
Baseline, postoperative 1 week, postoperative 1 month, and postoperative 3 months
|
|
Montreal Cognitive Assessment (MoCA) Total Score
Time Frame: Baseline, postoperative 1 week, postoperative 1 month, and postoperative 3 months
|
Cognitive function assessed using the Montreal Cognitive Assessment (MoCA).
The total score ranges from 0 to 30, with higher scores indicate better cognitive function.
|
Baseline, postoperative 1 week, postoperative 1 month, and postoperative 3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Glioma
- Brain Neoplasms
Other Study ID Numbers
- 2026-BRAIN-TUMOR-COG-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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