- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Bo Wang
- Telefonnummer: 022-59065262
- E-post: dr.bo.wang@tmu.edu.cn
Studieorter
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, Kina, 300350
- Tianjin Huanhu Hospital
-
Kontakt:
- Bo Wang
- Telefonnummer: 022-59065262
- E-post: dr.bo.wang@tmu.edu.cn
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mini-Mental State Examination (MMSE) Total Score
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Neoplasmer efter plats
- Neoplasmer
- Neoplasmer efter histologisk typ
- Neoplasmer, körtel och epitel
- Neoplasmer, neuroepitelial
- Neuroektodermala tumörer
- Neoplasmer, könsceller och embryonala
- Neoplasmer, nervvävnad
- Neoplasmer i nervsystemet
- Neoplasmer i centrala nervsystemet
- Gliom
- Neoplasmer i hjärnan
Andra studie-ID-nummer
- 2026-BRAIN-TUMOR-COG-01
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
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