Anterior Large Vessel Occlusion StrokeNCT06564129
Prediction of Anterior Circulation Large Vessel Occlusion Stroke With EEG
An observational study of Anterior Large Vessel Occlusion Stroke, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This study is designed to evaluate the accuracy of saline electrode EEG in the prehospital diagnosis of LVO-a stroke. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anterior Large Vessel Occlusion Stroke
- What is being tested?
- electroencephalography
- Type of treatment
- Medical device
- How many people
- 1,194 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 31 Dec 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients with suspected stroke or known stroke were included in the study
Who may be able to join
- Phase I.1.Acute ischemic stroke caused by occlusion of the anterior circulation (intracranial origin of the internal carotid artery or proximal middle cerebral artery (M1/M2)) confirmed by CTA, MRA or DSA (diagnosis in accordance with the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023")；2. Patient age ≥18 years；3: Last normal time to EEG acquisition time ≤ 72 hours；4: Signed informed consent.
- Phase II-III
- Diagnosed by a healthcare professional as a suspected acute stroke patient or a known acute stroke patient
- Patient age ≥18 years
- Last normal time to EEG acquisition time ≤ 24 hours
- Signed informed consent
Who cannot join
- Wounds in the area of electrode cap placement or active infection in the scalp;
- Patients who do not cooperate with the EEG examination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characteristics and Prehospital Triage of Anterior Large Vessel Occlusion Stroke Based on EEG
This study is designed to evaluate the accuracy of saline electrode EEG in the prehospital diagnosis of LVO-a stroke.
Read the detailed description
This is a multicenter, prospective, observational study,which will screen a total of 1194 patients in the participating centers during the period of June 1, 2024-December 31, 2025, and record single scalp EEG signals with eyes open at rest in the lying position of the patients using a non-invasive EEG acquisition device, and collect clinical data.
- Conditions
- Anterior Large Vessel Occlusion Stroke
- Being tested
- electroencephalography
- Keywords
- anterior large vessel occlusion stroke, electroencephalography, prehospital triage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroencephalographyDevice
Fifty-nine EEG electrodes conforming to international standard points were placed using a saline electrode EEG cap (Gelfree, Prysmian, China), and an accompanying portable multimodal EEG acquisition system (Neurohub, Prysmian, China) was used. EEG data were collected using collect software (Brycon, China).
What is being measured
The primary outcome is the main question the study is designed to answer.
Saline electrode EEG characteristics: area under the ROC curve for theta/alpha ratio;
Accuracy of theta/alpha ratio of electroencephalographic features for the diagnosis of large vessel occlusion
Accuracy of theta/alpha ratio of electroencephalographic features for the diagnosis of anterior large vessel occlusion stroke
Measured: 24 hours
Secondary outcomes (3)
Other EEG features including relative δ, θ, α power, δ/α ratio, δ+θ/α+β ratio, pdBSI, and WPLI diagnostic accuracy for LVO-a;
ROC curves were plotted for each EEG data feature predicting LVO-a, and sensitivity, specificity, PPV, and NPV were calculated at the optimal cutoff value.
Measured: 24 hours
Logic and technical feasibility of saline electrode EEG in ambulance for suspected stroke patients by paramedics;
Remove EEG data artifacts and report the percentage of EEG data available for analysis for each patient
Measured: 24 hours
Development of one or more new algorithms for optimal diagnosis of LVO-a based on EEG data
ROC curves for predicted LVO-a based on this algorithm were plotted and sensitivity, specificity, PPV and NPV were calculated at the optimal cutoff value.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Large Vessel Occlusion StrokeStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junwei Hao, MD, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564129
- Sponsor's protocol ID
- XMEC-2024-01
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 21 Aug 2024
- 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 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Prehospital Triage of Anterior Large Vessel Occlusion Stroke Based on EEG
- ClinicalTrials.gov ID
- NCT06564129
- Acronym / sponsor ID
- XMEC-2024-01
- Conditions
- Anterior Large Vessel Occlusion Stroke
- Keywords
- anterior large vessel occlusion stroke, electroencephalography, prehospital triage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,194 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Aug 2024 (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.
This study is designed to evaluate the accuracy of saline electrode EEG in the prehospital diagnosis of LVO-a stroke.
Detailed description
This is a multicenter, prospective, observational study,which will screen a total of 1194 patients in the participating centers during the period of June 1, 2024-December 31, 2025, and record single scalp EEG signals with eyes open at rest in the lying position of the patients using a non-invasive EEG acquisition device, and collect clinical data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with suspected stroke or known stroke were included in the study
Key inclusion criteria (6 listed)
- Phase I.1.Acute ischemic stroke caused by occlusion of the anterior circulation (intracranial origin of the internal carotid artery or proximal middle cerebral artery (M1/M2)) confirmed by CTA, MRA or DSA (diagnosis in accordance with the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023")；2. Patient age ≥18 years；3: Last normal time to EEG acquisition time ≤ 72 hours；4: Signed informed consent.
- Phase II-III
- Diagnosed by a healthcare professional as a suspected acute stroke patient or a known acute stroke patient
- Patient age ≥18 years
- Last normal time to EEG acquisition time ≤ 24 hours
Key exclusion criteria (2 listed)
- Wounds in the area of electrode cap placement or active infection in the scalp;
- Patients who do not cooperate with the EEG examination.
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 |
|---|---|---|
| electroencephalographyFifty-nine EEG electrodes conforming to international standard points were placed using a saline electrode EEG cap (Gelfree, Prysmian, China), and an accompanying portable multimodal EEG acquisition system (Neurohub, Prysmian, China) was used. EEG data were collected using collect software (Brycon, China). | Device | – |
Primary outcome
Saline electrode EEG characteristics: area under the ROC curve for theta/alpha ratio;
Time frame: 24 hours
Accuracy of theta/alpha ratio of electroencephalographic features for the diagnosis of large vessel occlusion Accuracy of theta/alpha ratio of electroencephalographic features for the diagnosis of anterior large vessel occlusion stroke
3 secondary outcomes
Other EEG features including relative δ, θ, α power, δ/α ratio, δ+θ/α+β ratio, pdBSI, and WPLI diagnostic accuracy for LVO-a;
Time frame: 24 hours
Logic and technical feasibility of saline electrode EEG in ambulance for suspected stroke patients by paramedics;
Time frame: 24 hours
Development of one or more new algorithms for optimal diagnosis of LVO-a based on EEG data
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Large Vessel Occlusion Stroke, run by Xuanwu Hospital, Beijing 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 6 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 21 Aug 2024. 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?
Contact junwei Hao, MD (01083198277, haojunwei@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saline electrode EEG characteristics: area under the ROC curve for theta/alpha ratio; (time frame: 24 hours). 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 21 Aug 2024.