A Clinical Study of Epilepsy Localization and Prognosis B... | NCT05567042

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

NCT05567042

Sponsor

Li Shuangshuang

Status

Unknown status

Last Update Posted

Oct 5, 2022Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Epileptic Seizure

Interventions

No intervention

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2022Estimated

Primary Completion Date

Dec 2023Estimated

Completion Date

Jul 2024Estimated

First Submitted Date

Sep 26, 2022

First Submission Date that Met QC Criteria

Oct 4, 2022

First Posted Date

Oct 5, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2022

Last Update Posted Date

Oct 5, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

By following up the prognosis of surgical patients, the application value of Cortex ID quantitative analysis in the localization of epilepsy foci was studied.
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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
drug-resistant epilepsy		No intervention	Other: No intervention
Medication is effective		No intervention	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	Medication is effective drug-resistant epilepsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Seizure frequency		2022-2024
Seizure duration		2022-2024

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Observational study of epilepsy patients treated at the Epilepsy Center of Xijing Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lei Ma, doctor	Contact	13325437929		shuangshuang9904@163.com
Shuangshuang Li, doctor	Contact	13325437929		shuangshuang9904@163.com

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34177777	Background	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.

ID	Term
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms