NCT05776745

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2023

Completed
Last Updated

March 20, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

February 7, 2023

Last Update Submit

March 8, 2023

Conditions

Epilepsy

Keywords

EpilepsyStereoelectroencephalographySpeech

Outcome Measures

Primary Outcomes (1)

  • Phonetic Feature Encoding in Human Superior Temporal Gyrus

    Phonetic Feature Encoding in Human Superior Temporal Gyrus

    through study completion, an average of 1 year

Study Arms (1)

Epileptic

EXPERIMENTAL

Epileptic with stereoelectroencephalography

Behavioral: SpeechDevice: Stereoelectroencephalography

Interventions

SpeechBEHAVIORAL

Patients read specific words and sentences

Epileptic
StereoelectroencephalographyDEVICE

Using stereoelectroencephalography to record the Intracranial EEG of the patient

Epileptic

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with focal refractory epilepsy also need preoperative evaluation with SEEG

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang University School of Medicine Second Affiliated Hospital

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

EpilepsySpeech

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVerbal BehaviorCommunicationBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neurosurgeon, Assistant Professor

Study Record Dates

First Submitted

February 7, 2023

First Posted

March 20, 2023

Study Start

March 20, 2022

Primary Completion

October 20, 2022

Study Completion

December 25, 2023

Last Updated

March 20, 2023

Record last verified: 2023-03

Locations

CN(1)