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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05567042
Other study ID # 20222137
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2022
Est. completion date July 2024

Study information

Verified date October 2022
Source Xijing Hospital
Contact Lei Ma, doctor
Phone 13325437929
Email shuangshuang9904@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

1. By following up the prognosis of surgical patients, the application value of Cortex ID quantitative analysis in the localization of epilepsy foci was studied. 2. By studying the correlation between autonomic nerve function and epilepsy neural network in epilepsy patients, and analyzing the differences between different epilepsy patients, it can provide more information for judging the prognosis of epilepsy patients.


Description:

This study included diagnostic trials and case-control studies, which were observational studies with no intervention. First, the demographic and clinical information of epilepsy patients in the Neurology Department of Xijing Hospital were collected, including gender, age, age of onset, course of epilepsy, seizure performance before treatment, seizure frequency before treatment, type and dose of antiepileptic drugs, past history, Family history, etc., as well as imaging, EEG, quality of life, and neuropsychological assessment, etc. were collected; secondly, functional magnetic resonance imaging (fMRI) and 24-hour Holter monitoring were performed on patients who met the inclusion criteria. Positron Emission Computed Tomography (PET) images of patients who have undergone or plan to undergo surgery are analyzed; finally, appropriate statistical methods are used for analysis.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date July 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: Meet the diagnostic criteria for epilepsy, - No contraindications for fMRI examination. - The patient had no other heart and lung diseases except epilepsy. - Patients and their families were aware of this study and signed informed consent. Exclusion Criteria: - Patients with severe infection, cerebrovascular disease, malignant tumor and other systemic diseases that can affect the nervous system, and those with serious dysfunction of the heart, liver, kidney and other organs. - Non-epileptic seizures such as syncope and hysteria. - Pregnant or lactating women. Incomplete clinical data

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No intervention

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Li Shuangshuang

References & Publications (1)

Kassinopoulos M, Harper RM, Guye M, Lemieux L, Diehl B. Altered Relationship Between Heart Rate Variability and fMRI-Based Functional Connectivity in People With Epilepsy. Front Neurol. 2021 Jun 10;12:671890. doi: 10.3389/fneur.2021.671890. eCollection 2021. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Seizure frequency 2022-2024
Primary Seizure duration 2022-2024
See also
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Completed NCT03860467 - Epileptic Seizures in Intensive Care Units