NCT05567042

Brief Summary

  1. 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

October 5, 2022

Status Verified

October 1, 2022

Enrollment Period

1.2 years

First QC Date

September 26, 2022

Last Update Submit

October 4, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Seizure frequency

    2022-2024

  • Seizure duration

    2022-2024

Study Arms (2)

drug-resistant epilepsy

No intervention

Other: No intervention

Medication is effective

No intervention

Other: No intervention

Interventions

No intervention

Medication is effectivedrug-resistant epilepsy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 34177777BACKGROUND

MeSH Terms

Conditions

Seizures

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Shuangshuang Li, doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 26, 2022

First Posted

October 5, 2022

Study Start

October 1, 2022

Primary Completion

December 1, 2023

Study Completion

July 1, 2024

Last Updated

October 5, 2022

Record last verified: 2022-10