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StrokeNCT05620966

EEG to Diagnose TIA and Stroke

An observational study of Stroke and Transient Ischemic Attack, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

When an individual experiences a sudden onset of neurological symptoms, such as one-sided weakness, visual abnormalities, and/or slurred speech, there is concern that they are having a transient ischemic attack/stroke. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Transient Ischemic Attack
What is being tested?
CGX Systems Quick-20m
Type of treatment
Medical device
How many people
21 participants
Where
1 siteCanada
Study dates
24 Oct 2022to 18 Nov 2022
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: Participants for this study will be patients of Sunnybrook Health Sciences Centre. Patients can be enrolled into the study from the emergency department, inpatient stroke ward, and neurology clinics at Sunnybrook Health Sciences Centre.

Who may be able to join

  • Patient of Sunnybrook Health Sciences Centre
  • Patient fits one of the three study arms: 1) transient neurological symptoms at any time point; 2) have a known stroke; 3) no prior history of stroke.

Who cannot join

  • Known skull defect
  • Previous neurological procedure
  • Significant physical impairment that would restrict the ability to use the portable EEG devices

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Dr. Mark I. Boulos - Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N3M5

Other trials in Canada

About this study

Official title: Evaluating the Feasibility of a Portable Electroencephalogram Device in Diagnosing Transient Ischemic Attack and Stroke

When an individual experiences a sudden onset of neurological symptoms, such as one-sided weakness, visual abnormalities, and/or slurred speech, there is concern that they are having a transient ischemic attack/stroke. A stroke is a medical emergency that requires immediate treatment and further evaluation to prevent a future stroke. Unfortunately, when a patient presents to the emergency department or a clinic with transient or mildly observable neurological symptoms, it is difficult to diagnose a stroke and many times, imaging may not reveal a stroke. This poses the risk of discharging patients without appropriate stroke care. This study aims to evaluate the feasibility of administering portable electroencephalogram (EEG) devices to diagnose transient ischemic attack/stroke. An EEG is a device that measures electrical activity in the brain. This study involves comparing EEG data of individuals who present with transient neurological symptoms or have known stroke with EEG data of generally healthy individuals. From this study, the investigators anticipate that it will be feasible to administer portable EEG and that portable EEG can be used to accurately diagnose stroke.

Read the detailed description

Transient ischemic attack (TIA) has classically been defined as an ischemic episode, in which patients can present with transient neurological symptoms, in the absence of brain injury. However, recent literature showed evidence of cerebral tissue injury in TIA, which suggests that focal cerebral ischemic events are essentially cerebral infarctions. Based on this, TIA should be considered a minor ischemic stroke. TIA/minor stroke, as all strokes, should be considered a medical emergency. Identifying and treating patients with TIA in a timely manner is important for stroke prevention. Literature suggests that more than 10% of patients diagnosed with TIA have a stroke within the next 90 days, of which half of these cases occur in the first 48 hours.

When a patient presents to the emergency department or an outpatient clinic with transient or mildly observable neurologic symptoms, it is difficult to diagnose an ischemic event from other TIA/stroke mimics such as migraine, seizure, etc. This is mostly because diagnosis of TIA/minor stroke relies on subjective, retrospective report. One study found that about 45% of referrals to a rapid stroke prevention clinic for query TIA/stroke were TIA mimics. Diagnosis also becomes more uncertain for patients who present with symptoms other than motor and speech deficits, which are more classically seen with brain ischemia, such as dizziness or sensory symptoms.

Advances in brain imaging have facilitated the evaluation of brain injury in the context of transient neurological symptoms. Diffusion-weighted MRI can show infarcts in one-third of patients with TIA. However, this poses the risk of missing patients who are MRI-negative and discharging patients without appropriate stroke preventative care. Furthermore, there are also resource limitations, which make it difficult to do an MRI brain in all patients who present with transient or mildly observable neurological symptoms. For example, there is limited time during a code stroke, which makes a CT scan the more feasible option, and additionally there are resource constraints depending on the setting of care (ie rural setting, outpatient clinic). Therefore, this warrants the need for a portable diagnostic device to assist with timely and accurate evaluation of possible TIA/stroke.

Electroencephalogram (EEG), which is typically used in the context of epilepsy, provides a non-invasive measure of brain function. EEG also has potential to detect cerebral ischemia, given that there are metabolic and electrical changes of cortical neurons during times of reduced cerebral blood flow. However, the use of EEG and specifically portable EEG, in the context of acute stroke and TIA is limited.

In the literature, one study found that a 3-minute portable resting EEG accurately identified patients with large acute ischemic strokes in the emergency department and correlated with infarct volume. Another study, which used a 3-minute EEG obtained from a single electrode over the left frontal lobe, found unique EEG profiles for TIA versus ischemic stroke patients. However, these preliminary findings were limited due to small sample size and EEG data typically was obtained on the second day after symptom onset.

This study involves the use of portable EEG device, CGX Systems Quick-20m device, to diagnose TIA/stroke by aiming to find an electrical signature that is specific to TIA/stroke versus cerebral perfusion. The investigators anticipate doing this by comparing EEG data in patients who present with transient neurological symptoms or have known stroke and are candidates for hyperacute treatment, such as thrombolysis or thrombectomy, with EEG data in patients who obtained revascularization and resumption of cerebral perfusion following hyperacute treatment for stroke or in generally healthy individuals with no stroke history.

Primary Objective: To assess the feasibility of administering a portable EEG device in the context of acute TIA/stroke.

Secondary Objectives:

  1. To evaluate the effectiveness of portable EEG in accurately diagnosing TIA/stroke. ii. To explore potential EEG changes from stroke-related reperfusion
Being tested
CGX Systems Quick-20m
Keywords
EEG, Stroke, Transient ischemic attack
Medical subject headings
Stroke, Ischemic Attack, Transient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CGX Systems Quick-20mDevice

    Also called Portable EEG device

    The Quick-20m is an FDA-approved wireless, battery-operated 10-20 montage EEG headset, which utilizes dry sensor technology. This device provides an integrated approach to the wireless acquisition of electrical potentials arising from activity in the cortex. The Quick-20m includes advanced amplification and shielding to reject ambient electrical noise. The Quick-20m is placed on the participant's scalp and requires minimal scalp preparation. No conductive gel is used. Patients may or may not have hair. The sensor pads must have direct contact with the scalp and hair will be maneuvered to obtain direct contact. All three arms of participants will receive this intervention.

Study groups in NCT05620966
Study groupRoleWhat they receive
Patients with transient neurological symptoms and CT-negative for strokePatients may have transient neurological symptoms at any time point
Receives: Device: CGX Systems Quick-20m
Patients with known stroke confirmed either on imaging or by stroke physicianNot described
Receives: Device: CGX Systems Quick-20m
Patients with no prior history of strokeNot described
Receives: Device: CGX Systems Quick-20m

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of administering a portable EEG device in the context of acute TIA/stroke

    1. Percentage of recruited patients who obtain an EEG recording within 5 minutes; 2) Percentage of adequate EEG recordings (>/= 3 minutes of good quality signal, which is defined as >80% of EEG channels with good impedance)

    Measured: Through study completion, an average of 1 year

Secondary outcomes (2)
  1. Effectiveness of portable EEG in accurately diagnosing TIA/stroke

    Compare electric waveforms from portable EEG device between patients with known stroke (as confirmed by imaging or stroke physician), with patients with confirmed TIA (patients who present with transient neurological symptoms and confirmed diagnosis by stroke physician), and controls (no prior stroke history).

    Measured: Through study completion, an average of 1 year

  2. EEG changes from stroke-related reperfusion

    Compare electric waveforms from portable EEG device in patients with stroke before and after hyperacute stroke treatment (ie thrombolysis or thrombectomy).

    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.

  1. First posted17 Nov 2022
  2. Study start24 Oct 2022
  3. Primary completion18 Nov 2022
  4. Study completion18 Nov 2022

Resources

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
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05620966
Sponsor's protocol ID
5445
Status last verified
May 2024
First submitted
7 Sep 2022
Last updated
16 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Easton JD, Johnston SC. Time to Retire the Concept of Transient Ischemic Attack. JAMA. 2022 Mar 1;327(9):813-814. doi: 10.1001/jama.2022.0300. No abstract available.

    PubMed 35147656
  • Fitzpatrick T, Gocan S, Wang CQ, Hamel C, Bourgoin A, Dowlatshahi D, Stotts G, Shamy M. How do neurologists diagnose transient ischemic attack: A systematic review. Int J Stroke. 2019 Feb;14(2):115-124. doi: 10.1177/1747493018816430. Epub 2018 Dec 3.

    PubMed 30507363
  • Johnston SC, Gress DR, Browner WS, Sidney S. Short-term prognosis after emergency department diagnosis of TIA. JAMA. 2000 Dec 13;284(22):2901-6. doi: 10.1001/jama.284.22.2901.

    PubMed 11147987
  • Bradley D, Cronin S, Kinsella JA, Tobin WO, Mahon C, O'Brien M, Lonergan R, Cooney MT, Kennelly S, Collins DR, O'Neill D, Coughlan T, Smyth S, McCabe DJ. Frequent inaccuracies in ABCD2 scoring in non-stroke specialists' referrals to a daily Rapid Access Stroke Prevention service. J Neurol Sci. 2013 Sep 15;332(1-2):30-4. doi: 10.1016/j.jns.2013.05.030. Epub 2013 Jul 17.

    PubMed 23871489
  • Foreman B, Claassen J. Quantitative EEG for the detection of brain ischemia. Crit Care. 2012 Dec 12;16(2):216. doi: 10.1186/cc11230. No abstract available.

    PubMed 22429809
  • Shreve L, Kaur A, Vo C, Wu J, Cassidy JM, Nguyen A, Zhou RJ, Tran TB, Yang DZ, Medizade AI, Chakravarthy B, Hoonpongsimanont W, Barton E, Yu W, Srinivasan R, Cramer SC. Electroencephalography Measures are Useful for Identifying Large Acute Ischemic Stroke in the Emergency Department. J Stroke Cerebrovasc Dis. 2019 Aug;28(8):2280-2286. doi: 10.1016/j.jstrokecerebrovasdis.2019.05.019. Epub 2019 Jun 4.

    PubMed 31174955
  • Rogers JM, Bechara J, Middleton S, Johnstone SJ. Acute EEG Patterns Associated With Transient Ischemic Attack. Clin EEG Neurosci. 2019 May;50(3):196-204. doi: 10.1177/1550059418790708. Epub 2018 Jul 25.

    PubMed 30045636

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke and Transient Ischemic Attack, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

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 2 inclusion and 3 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 May 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 Canada. 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?

Feasibility of administering a portable EEG device in the context of acute TIA/stroke (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?

On the ClinicalTrials.gov record for NCT05620966, which also lists 7 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 May 2024; AzTrials last refreshed its copy on 2 Nov 2026.

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