Study of Speech Function in Epileptic Patients Based on S... | NCT05776745

Studies
Study of Speech Function in Epileptic Patients Based on Stereoelectroencephalography Signal

NCT05776745

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Unknown status

Last Update Posted

Mar 20, 2023Actual

Enrollment

5Actual

Phase

Not Applicable

Conditions

Epilepsy

Interventions

Speech
Stereoelectroencephalography

Countries

China

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

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2022Actual

Primary Completion Date

Oct 20, 2022Actual

Completion Date

Dec 25, 2023Estimated

First Submitted Date

Feb 7, 2023

First Submission Date that Met QC Criteria

Mar 8, 2023

First Posted Date

Mar 20, 2023Actual

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

Mar 8, 2023

Last Update Posted Date

Mar 20, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hemmings Wu, Neurosurgeon, Assistant Professor, Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPrincipal Investigator

Lead Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang UniversityOTHER

Collaborators

Not provided

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

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Epileptic	Experimental	Epileptic with stereoelectroencephalography	Behavioral: Speech Device: Stereoelectroencephalography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Speech	Behavioral	Patients read specific words and sentences	Epileptic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Phonetic Feature Encoding in Human Superior Temporal Gyrus	Phonetic Feature Encoding in Human Superior Temporal Gyrus	through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhejiang University School of Medicine Second Affiliated Hospital		Hangzhou	Zhejiang	310009	China

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy
D013060	Speech

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014705	Verbal Behavior

Browse Leaves

Not provided

Browse Branches

Not provided