StrokeNCT01738412
Validation of an Electroencephalograph Based Algorithm for Detection of Onset and Deterioration of Acute Ischemic Stroke by Comparison to NIHSS
An observational study of Stroke, run by Neurokeeper Technologies at 1 site in Israel.
Trial summary
The purpose of this study is the validation of an Electroencephalograph based algorithm for detection of onset and deterioration of Acute Ischemic Stroke by Comparison to NIHSS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Neurokeeper stroke detector
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Stroke patients
Who may be able to join
- Age > 18 years old.
- Acute stroke symptoms onset within 2 weeks of inclusion, and as proximate to event as possible and as long as there was no neurological deterioration (ΔNIHSS>4) from symptoms onset to inclusion.
- Patients with TIA lasting at least 5 minutes or minor acute ischemic stroke (NIHSS < 4 at the time of enrolment)
- More than 3 of the following:
- Blood pressure >140/90 or unknown, Irregular heartbeat, Atrial Fibrillation, Smoker, Cholesterol >240 or unknown, Has Diabetes, Lack of physical exercise, Overweight, Has Stroke in the family
- OR between 4 and 6 of the following:
- Blood pressure 120-139/80-89, Unknown Irregular heartbeat, Atrial Fibrillation, Trying to quit smoking, Cholesterol 200-239, Borderline Diabetes, Some exercise, Slightly overweight, Not sure if Stroke occurred in family
Who cannot join
- Intracranial hemorrhage on admission by CT.
- Previous major hemispheric stroke.
- Patients with pure sensory symptoms,
- Significant movement disorder.
- Local skull or skin affliction which prevents sensor application.
- Any known condition which in the opinion of the investigator may interfere with the protocol implementation.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera
Yaron River, MD, 97249532747, YaronR@hy.health.gov.il
Yaron River, MD
About this study
Official title: Validation of an Electroencephalograph Based Algorithm for Detection of Onset and Deterioration of Acute Ischemic Stroke by Comparison to NIHSS.
The purpose of this study is the validation of an Electroencephalograph based algorithm for detection of onset and deterioration of Acute Ischemic Stroke by Comparison to NIHSS.
Read the detailed description
Inclusion criteria study population
- Age > 18 years old.
- Acute stroke symptoms onset within 2 weeks of inclusion, and as proximate to event as possible and as long as there was no neurological deterioration (ΔNIHSS>4) from symptoms onset to inclusion.
- Patients with TIA lasting at least 5 minutes or minor acute ischemic stroke (NIHSS < 4 at the time of enrolment)
- More than 3 of the following:
Blood pressure >140/90 or unknown, Irregular heartbeat, Atrial Fibrillation, Smoker, Cholesterol >240 or unknown, Has Diabetes, Lack of physical exercise, Overweight, Has Stroke in the family
OR between 4 and 6 of the following:
Blood pressure 120-139/80-89, Unknown Irregular heartbeat, Atrial Fibrillation, Trying to quit smoking, Cholesterol 200-239, Borderline Diabetes, Some exercise, Slightly overweight, Not sure if Stroke occurred in family
Exclusion criteria study population
- Intracranial hemorrhage on admission by CT.
- Previous major hemispheric stroke.
- Patients with pure sensory symptoms,
- Significant movement disorder.
- Local skull or skin affliction which prevents sensor application.
- Any known condition which in the opinion of the investigator may interfere with the protocol implementation.
- Conditions
- Stroke
- Being tested
- Neurokeeper stroke detector
- Keywords
- Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurokeeper stroke detectorDevice
Monitoring stroke patients
| Study group | Role | What they receive |
|---|---|---|
| Study population | Stroke patients Receives: Device: Neurokeeper stroke detector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of stroke
EEG base algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation as assessed by NIHSS score.
Secondary outcomes (1)
Correlation to severity of stroke
Correlations between EEG + ERP changes and clinical status as assessed by NIHSS score.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurokeeper Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738412
- Sponsor's protocol ID
- NK-002
- Status last verified
- Nov 2012
- First submitted
- 28 Nov 2012
- Last updated
- 30 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Electroencephalograph Based Algorithm for Detection of Onset and Deterioration of Acute Ischemic Stroke by Comparison to NIHSS.
- ClinicalTrials.gov ID
- NCT01738412
- Acronym / sponsor ID
- NK-002
- Conditions
- Stroke
- Keywords
- Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Neurokeeper TechnologiesIndustry (pharma, biotech, devices)
- First posted
- 30 Nov 2012 (estimated)
- 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.
The purpose of this study is the validation of an Electroencephalograph based algorithm for detection of onset and deterioration of Acute Ischemic Stroke by Comparison to NIHSS.
Detailed description
Inclusion criteria study population
- Age > 18 years old.
- Acute stroke symptoms onset within 2 weeks of inclusion, and as proximate to event as possible and as long as there was no neurological deterioration (ΔNIHSS>4) from symptoms onset to inclusion.
- Patients with TIA lasting at least 5 minutes or minor acute ischemic stroke (NIHSS < 4 at the time of enrolment)
- More than 3 of the following:
Blood pressure >140/90 or unknown, Irregular heartbeat, Atrial Fibrillation, Smoker, Cholesterol >240 or unknown, Has Diabetes, Lack of physical exercise, Overweight, Has Stroke in the family
OR between 4 and 6 of the following:
Blood pressure 120-139/80-89, Unknown Irregular heartbeat, Atrial Fibrillation, Trying to quit smoking, Cholesterol 200-239, Borderline Diabetes, Some exercise, Slightly overweight, Not sure if Stroke occurred in family
Exclusion criteria study population
- Intracranial hemorrhage on admission by CT.
- Previous major hemispheric stroke.
- Patients with pure sensory symptoms,
- Significant movement disorder.
- Local skull or skin affliction which prevents sensor application.
- Any known condition which in the opinion of the investigator may interfere with the protocol implementation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | Device: Neurokeeper stroke detectorStroke patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients
Key inclusion criteria (7 listed)
- Age > 18 years old.
- Acute stroke symptoms onset within 2 weeks of inclusion, and as proximate to event as possible and as long as there was no neurological deterioration (ΔNIHSS>4) from symptoms onset to inclusion.
- Patients with TIA lasting at least 5 minutes or minor acute ischemic stroke (NIHSS < 4 at the time of enrolment)
- More than 3 of the following:
- Blood pressure >140/90 or unknown, Irregular heartbeat, Atrial Fibrillation, Smoker, Cholesterol >240 or unknown, Has Diabetes, Lack of physical exercise, Overweight, Has Stroke in the family
Key exclusion criteria (6 listed)
- Intracranial hemorrhage on admission by CT.
- Previous major hemispheric stroke.
- Patients with pure sensory symptoms,
- Significant movement disorder.
- Local skull or skin affliction which prevents sensor application.
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 |
|---|---|---|
| Neurokeeper stroke detectorMonitoring stroke patients | Device | Study population |
Primary outcome
Detection of stroke
EEG base algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation as assessed by NIHSS score.
1 secondary outcome
Correlation to severity of stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2012.
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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 Stroke, run by Neurokeeper Technologies at 1 site in Israel.
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 7 inclusion and 6 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 30 Nov 2012. 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 Israel. 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 Shay Bar Haim, Msc (972506822824, shaybarhaim@neurokeeper.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of stroke. 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 30 Nov 2012.