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Study of Speech Function in Epileptic Patients Based on Stereoelectroencephalography Signal

Primary Purpose

Epilepsy

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Speech
Stereoelectroencephalography
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Epilepsy focused on measuring Epilepsy, Stereoelectroencephalography, Speech

Eligibility Criteria

16 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with focal refractory epilepsy also need preoperative evaluation with SEEG Exclusion Criteria: History of major depression or psychiatric disorders and medication that causes symptoms of psychiatric disorders Patients with severe cognitive impairment (MMSE score ≤15), unable to complete the language function test

Sites / Locations

  • Zhejiang University School of Medicine Second Affiliated Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Epileptic

Arm Description

Epileptic with stereoelectroencephalography

Outcomes

Primary Outcome Measures

Phonetic Feature Encoding in Human Superior Temporal Gyrus
Phonetic Feature Encoding in Human Superior Temporal Gyrus

Secondary Outcome Measures

Full Information

First Posted
February 7, 2023
Last Updated
March 8, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05776745
Brief Title
Study of Speech Function in Epileptic Patients Based on Stereoelectroencephalography Signal
Official Title
Study of Speech Function in Epileptic Patients Based on Stereoelectroencephalography Signal
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 20, 2022 (Actual)
Primary Completion Date
October 20, 2022 (Actual)
Study Completion Date
December 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Based on stereoelectroencephalography model in the treatment of epilepsy patients, this study conducted language-related experimental studies without interfering with normal monitoring treatment. Meanwhile, voice data and intracranial electrophysiological data were collected for analysis. To study the mechanism related to the language function of patients, try to establish a model to decode the intracranial electrophysiological data related to language.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, Stereoelectroencephalography, Speech

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epileptic
Arm Type
Experimental
Arm Description
Epileptic with stereoelectroencephalography
Intervention Type
Behavioral
Intervention Name(s)
Speech
Intervention Description
Patients read specific words and sentences
Intervention Type
Device
Intervention Name(s)
Stereoelectroencephalography
Intervention Description
Using stereoelectroencephalography to record the Intracranial EEG of the patient
Primary Outcome Measure Information:
Title
Phonetic Feature Encoding in Human Superior Temporal Gyrus
Description
Phonetic Feature Encoding in Human Superior Temporal Gyrus
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with focal refractory epilepsy also need preoperative evaluation with SEEG Exclusion Criteria: History of major depression or psychiatric disorders and medication that causes symptoms of psychiatric disorders Patients with severe cognitive impairment (MMSE score ≤15), unable to complete the language function test
Facility Information:
Facility Name
Zhejiang University School of Medicine Second Affiliated Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China

12. IPD Sharing Statement

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Study of Speech Function in Epileptic Patients Based on Stereoelectroencephalography Signal

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