Ischemic StrokeNCT06492681
Correlation Between Optic Nerve Sheath Diameter and Neurological Deficit in Adult Patients With Suspected Ischemic Stroke
An observational study of Ischemic Stroke, run by Clinica Mexico at 1 site in Mexico.
Trial summary
The ultrasound of the optic nerve sheath diameter (ONSD) is a non-invasive tool used in the detection of intracranial hypertension and other neurological conditions. The aim of this research is to evaluate the correlation between the ultrasound measurement of the optic nerve sheath diameter and the side of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- How many people
- 19 participants
- Where
- 1 siteMexico
- Study dates
- 1 Sep 2024to 1 Sep 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
- No healthy volunteers
- Adult, Older adult
Study population: The study aims to include a diverse adult population, encompassing various ages, genders, and ethnic backgrounds, reflective of the general demographic seen in emergency departments with suspected ischemic stroke. By doing so, the study seeks to enhance the generalizability of its findings across different subgroups within the adult population.
Who may be able to join
- Patients with suspected acute ischemic stroke
- CT scan negative to hemorrhagic stroke
- Informed consent
Who cannot join
- Contraindications to perform ocular ultrasound
- Patients with ocular surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Optic Nerve Sheath Diameter Measured by POCUS and Neurological Deficit in Physical Examination in Adult Patients With Suspected Ischemic Stroke Evaluated in Emergency Departments
The ultrasound of the optic nerve sheath diameter (ONSD) is a non-invasive tool used in the detection of intracranial hypertension and other neurological conditions. The aim of this research is to evaluate the correlation between the ultrasound measurement of the optic nerve sheath diameter and the side of neurological focus in the physical examination of adult patients evaluated in emergency departments.
Read the detailed description
II. Hypothesis The ultrasound measurement of the optic nerve sheath diameter correlates with the side of neurological focus in the physical examination of adult patients evaluated in emergency departments.
III. Objectives Estimate the correlation between the ultrasound measurement of the optic nerve sheath diameter and the side of neurological focus in the physical examination of adult patients evaluated in emergency departments.
Determine the sensitivity and specificity of the ultrasound measurement of the optic nerve sheath diameter for predicting the side of neurological focus.
IV. Methodology
Study design:
A observational study will be conducted in a secondary care hospital.
Population and sample:
Adult patients (≥18 years) presenting to the emergency department with neurological symptoms, such as headache, altered level of consciousness, motor or sensory deficit, among others, will be included. Patients with contraindications for ocular ultrasound or with a history of previous ocular surgery will be excluded.
Procedures:
- Informed consent will be obtained from patients who meet the inclusion criteria.
- A neurological physical examination will be performed to identify the side of neurological focus.
- The optic nerve sheath diameter will be measured using ultrasound with a high-frequency linear transducer (7.5-12 MHz).
- Demographic, clinical, and ultrasound data will be recorded for the patients.
Data analysis:
The correlation between the ultrasound measurement of the optic nerve sheath diameter and the side of neurological focus will be calculated using Pearson's or Spearman's correlation coefficient, depending on the distribution of the data. Additionally, sensitivity, specificity, positive and negative predictive values, and 95% confidence intervals will be calculated to determine the diagnostic utility of the ultrasound measurement of the optic nerve sheath diameter in identifying the side of neurological focus.
- Ethical considerations The ethical guidelines established by the Declaration of Helsinki will be followed, and the privacy and confidentiality of patients will be protected. The protocol will be approved by the hospital's Research Ethics Committee before its implementation.
- Conditions
- Ischemic Stroke
- Keywords
- optic nerve sheath diameter, stroke, emergency department
- Medical subject headings
- Ischemic Stroke, Stroke, Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between optic nerve sheath and side of clinical neurological focalization
Estimate the correlation between the ultrasound measurement of the optic nerve sheath diameter and the side of neurological focus in the physical examination of adult patients evaluated in emergency departments.
Measured: In the first 4 hours of arrival to Emergency Department
Secondary outcomes (1)
sensitivity and specificity of the ultrasound measurement of the optic nerve sheath diameter for predicting the side of neurological focus.
Determine the sensitivity and specificity of the ultrasound measurement of the optic nerve sheath diameter for predicting the side of neurological focus.
Measured: In the first 4 hours of arrival to Emergency Department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Sep 2024
- Primary completion30 Aug 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ischemic 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Ivan Rodriguez de Molina Serrano, Clinica Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492681
- Sponsor's protocol ID
- 00001
- Status last verified
- Sep 2025
- First submitted
- 1 Jul 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lau T, Ahn JS, Manji R, Kim DJ. A Narrative Review of Point of Care Ultrasound Assessment of the Optic Nerve in Emergency Medicine. Life (Basel). 2023 Feb 15;13(2):531. doi: 10.3390/life13020531.
PubMed 36836888Nathani A, Ghamande SA, Kambhampati S, Anderson B, Lohse M, White HD. The Use of POCUS-Obtained Optic Nerve Sheath Diameter in Intracerebral Hemorrhage. POCUS J. 2023 Nov 27;8(2):170-174. doi: 10.24908/pocus.v8i2.16563. eCollection 2023.
PubMed 38099170Rajajee V, Vanaman M, Fletcher JJ, Jacobs TL. Optic nerve ultrasound for the detection of raised intracranial pressure. Neurocrit Care. 2011 Dec;15(3):506-15. doi: 10.1007/s12028-011-9606-8.
PubMed 21769456Bauerle J, Lochner P, Kaps M, Nedelmann M. Intra- and interobsever reliability of sonographic assessment of the optic nerve sheath diameter in healthy adults. J Neuroimaging. 2012 Jan;22(1):42-5. doi: 10.1111/j.1552-6569.2010.00546.x. Epub 2010 Dec 1.
PubMed 21121998Kimberly HH, Shah S, Marill K, Noble V. Correlation of optic nerve sheath diameter with direct measurement of intracranial pressure. Acad Emerg Med. 2008 Feb;15(2):201-4. doi: 10.1111/j.1553-2712.2007.00031.x.
PubMed 18275454
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Optic Nerve Sheath Diameter Measured by POCUS and Neurological Deficit in Physical Examination in Adult Patients With Suspected Ischemic Stroke Evaluated in Emergency Departments
- ClinicalTrials.gov ID
- NCT06492681
- Acronym / sponsor ID
- 00001
- Conditions
- Ischemic Stroke
- Keywords
- optic nerve sheath diameter, stroke, emergency department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Clinica MexicoUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 9 Jul 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.
The ultrasound of the optic nerve sheath diameter (ONSD) is a non-invasive tool used in the detection of intracranial hypertension and other neurological conditions. The aim of this research is to evaluate the correlation between the ultrasound measurement of the optic nerve sheath diameter and the side of neurological focus in the physical examination of adult patients evaluated in emergency departments.
Detailed description
II. Hypothesis The ultrasound measurement of the optic nerve sheath diameter correlates with the side of neurological focus in the physical examination of adult patients evaluated in emergency departments.
III. Objectives Estimate the correlation between the ultrasound measurement of the optic nerve sheath diameter and the side of neurological focus in the physical examination of adult patients evaluated in emergency departments.
Determine the sensitivity and specificity of the ultrasound measurement of the optic nerve sheath diameter for predicting the side of neurological focus.
IV. Methodology
Study design:
A observational study will be conducted in a secondary care hospital.
Population and sample:
Adult patients (≥18 years) presenting to the emergency department with neurological symptoms, such as headache, altered level of consciousness, motor or sensory deficit, among others, will be included. Patients with contraindications for ocular ultrasound or with a history of previous ocular surgery will be excluded.
Procedures:
- Informed consent will be obtained from patients who meet the inclusion criteria.
- A neurological physical examination will be performed to identify the side of neurological focus.
- The optic nerve sheath diameter will be measured using ultrasound with a high-frequency linear transducer (7.5-12 MHz).
- Demographic, clinical, and ultrasound data will be recorded for the patients.
Data analysis:
The correlation between the ultrasound measurement of the optic nerve sheath diameter and the side of neurological focus will be calculated using Pearson's or Spearman's correlation coefficient, depending on the distribution of the data. Additionally, sensitivity, specificity, positive and negative predictive values, and 95% confidence intervals will be calculated to determine the diagnostic utility of the ultrasound measurement of the optic nerve sheath diameter in identifying the side of neurological focus.
- Ethical considerations The ethical guidelines established by the Declaration of Helsinki will be followed, and the privacy and confidentiality of patients will be protected. The protocol will be approved by the hospital's Research Ethics Committee before its implementation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study aims to include a diverse adult population, encompassing various ages, genders, and ethnic backgrounds, reflective of the general demographic seen in emergency departments with suspected ischemic stroke. By doing so, the study seeks to enhance the generalizability of its findings across different subgroups within the adult population.
Key inclusion criteria (3 listed)
- Patients with suspected acute ischemic stroke
- CT scan negative to hemorrhagic stroke
- Informed consent
Key exclusion criteria (2 listed)
- Contraindications to perform ocular ultrasound
- Patients with ocular surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between optic nerve sheath and side of clinical neurological focalization
Time frame: In the first 4 hours of arrival to Emergency Department
Estimate the correlation between the ultrasound measurement of the optic nerve sheath diameter and the side of neurological focus in the physical examination of adult patients evaluated in emergency departments.
1 secondary outcome
sensitivity and specificity of the ultrasound measurement of the optic nerve sheath diameter for predicting the side of neurological focus.
Time frame: In the first 4 hours of arrival to Emergency Department
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Background: PubMed 36836888Lau T, Ahn JS, Manji R, Kim DJ. A Narrative Review of Point of Care Ultrasound Assessment of the Optic Nerve in Emergency Medicine. Life (Basel). 2023 Feb 15;13(2):531. doi: 10.3390/life13020531.
- Background: PubMed 38099170Nathani A, Ghamande SA, Kambhampati S, Anderson B, Lohse M, White HD. The Use of POCUS-Obtained Optic Nerve Sheath Diameter in Intracerebral Hemorrhage. POCUS J. 2023 Nov 27;8(2):170-174. doi: 10.24908/pocus.v8i2.16563. eCollection 2023.
- Background: PubMed 21769456Rajajee V, Vanaman M, Fletcher JJ, Jacobs TL. Optic nerve ultrasound for the detection of raised intracranial pressure. Neurocrit Care. 2011 Dec;15(3):506-15. doi: 10.1007/s12028-011-9606-8.
- Background: PubMed 21121998Bauerle J, Lochner P, Kaps M, Nedelmann M. Intra- and interobsever reliability of sonographic assessment of the optic nerve sheath diameter in healthy adults. J Neuroimaging. 2012 Jan;22(1):42-5. doi: 10.1111/j.1552-6569.2010.00546.x. Epub 2010 Dec 1.
- Background: PubMed 18275454Kimberly HH, Shah S, Marill K, Noble V. Correlation of optic nerve sheath diameter with direct measurement of intracranial pressure. Acad Emerg Med. 2008 Feb;15(2):201-4. doi: 10.1111/j.1553-2712.2007.00031.x.
- Individual participant dataSharing planned: No
Related trials for Ischemic Stroke
Not yet recruiting
Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Ischemic Stroke
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
Not yet recruiting
Accelerated Theta-Burst Stimulation for Refractory Central Post-Stroke Pain
Central Post-Stroke Pain, Stroke
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?
An observational study of Ischemic Stroke, run by Clinica Mexico at 1 site in Mexico.
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 3 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: finished, as of the sponsor's last update on 16 Sep 2025. 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 Mexico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation between optic nerve sheath and side of clinical neurological focalization (time frame: In the first 4 hours of arrival to Emergency Department). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06492681, which also lists 5 linked publications.
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 16 Sep 2025.