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A Clinical Study of Epilepsy Localization and Prognosis Based on PET and Resting-state fMRI

Sponsor
Li Shuangshuang (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05567042
Collaborator
(none)
50
Enrollment
21
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Clinical Study of Epilepsy Localization and Prognosis Based on Positron Emission Tomography and Resting-state Functional Magnetic Resonance Imaging
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
drug-resistant epilepsy

No intervention

Other: No intervention
No intervention
Medication is effective

No intervention

Other: No intervention
No intervention

Outcome Measures

Primary Outcome Measures

  1. Seizure frequency [2022-2024]

  2. Seizure duration [2022-2024]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Li Shuangshuang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Li Shuangshuang, Principal Investigator, Xijing Hospital
ClinicalTrials.gov Identifier:
NCT05567042
Other Study ID Numbers:
  • 20222137
First Posted:
Oct 5, 2022
Last Update Posted:
Oct 5, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Epilepsy
Seizures

Study Results

No Results Posted as of Oct 5, 2022