EpilepsyNCT05776745
Study of Speech Function in Epileptic Patients Based on Stereoelectroencephalography Signal
A study testing Speech and Stereoelectroencephalography in people with Epilepsy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Speech and Stereoelectroencephalography
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2022to 25 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with focal refractory epilepsy also need preoperative evaluation with SEEG
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Zhejiang University School of Medicine Second Affiliated Hospital
Hangzhou, Zhejiang, 310009
About this study
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.
- Conditions
- Epilepsy
- Being tested
- Speech, Stereoelectroencephalography
- Keywords
- Epilepsy, Stereoelectroencephalography, Speech
- Medical subject headings
- Epilepsy, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpeechBehavioural
Patients read specific words and sentences
StereoelectroencephalographyDevice
Using stereoelectroencephalography to record the Intracranial EEG of the patient
| Study group | Role | What they receive |
|---|---|---|
| Epileptic | Experimental | Epileptic with stereoelectroencephalography Receives: Behavioral: Speech; Device: Stereoelectroencephalography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phonetic Feature Encoding in Human Superior Temporal Gyrus
Phonetic Feature Encoding in Human Superior Temporal Gyrus
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start20 Mar 2022
- Primary completion20 Oct 2022
- Study completion25 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hemmings Wu, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776745
- Sponsor's protocol ID
- 2022-0113
- Status last verified
- Mar 2023
- First submitted
- 7 Feb 2023
- Last updated
- 20 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Speech Function in Epileptic Patients Based on Stereoelectroencephalography Signal
- ClinicalTrials.gov ID
- NCT05776745
- Acronym / sponsor ID
- 2022-0113
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Stereoelectroencephalography, Speech
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 25 Dec 2023 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epileptic | Experimental | Behavioral: Speech, Device: StereoelectroencephalographyEpileptic with stereoelectroencephalography |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with focal refractory epilepsy also need preoperative evaluation with SEEG
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpeechPatients read specific words and sentences | Behavioural | Epileptic |
| StereoelectroencephalographyUsing stereoelectroencephalography to record the Intracranial EEG of the patient | Device | Epileptic |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
Related trials for Epilepsy
RecruitingPhase 3
Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))
Mesial Temporal Lobe Epilepsy
RecruitingObservational study
Electrocardiographic Changes Associated With Epilepsy
ECG Changes
Recruiting
Combined CM and STN Stimulation for Motor Epilepsy
Motor Epilepsy
Not yet recruiting
Lily's Grace Temporal Interference
Epilepsy
Not yet recruiting
Characterisation of Laryngeal Evoked Potentials Induced by Vagus Nerve Stimulation in Refractory Epilepsy Patients
Refractory Epilepsy, Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech and Stereoelectroencephalography in people with Epilepsy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phonetic Feature Encoding in Human Superior Temporal Gyrus (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.