- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05776745
Study of Speech Function in Epileptic Patients Based on Stereoelectroencephalography Signal
March 8, 2023 updated by: Hemmings Wu, Second Affiliated Hospital, School of Medicine, Zhejiang University
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
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Hangzhou, Zhejiang, China, 310009
- Zhejiang University School of Medicine Second Affiliated Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 50 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Epileptic
Epileptic with stereoelectroencephalography
|
Patients read specific words and sentences
Using stereoelectroencephalography to record the Intracranial EEG of the patient
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phonetic Feature Encoding in Human Superior Temporal Gyrus
Time Frame: through study completion, an average of 1 year
|
Phonetic Feature Encoding in Human Superior Temporal Gyrus
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 20, 2022
Primary Completion (Actual)
October 20, 2022
Study Completion (Anticipated)
December 25, 2023
Study Registration Dates
First Submitted
February 7, 2023
First Submitted That Met QC Criteria
March 8, 2023
First Posted (Actual)
March 20, 2023
Study Record Updates
Last Update Posted (Actual)
March 20, 2023
Last Update Submitted That Met QC Criteria
March 8, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-0113
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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