EEG to Diagnose TIA and Stroke

NCT05620966 | Completed FDA Device

• 1 other identifier: 5445
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke; Transient Ischemic Attack

Keywords

EEG; Stroke; Transient ischemic attack

Outcome Measures

Primary Outcomes (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)

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Effectiveness of portable EEG in accurately diagnosing TIA/stroke

  Through study completion, an average of 1 year

• EEG changes from stroke-related reperfusion

  Through study completion, an average of 1 year

Study Arms (3)

Patients with transient neurological symptoms and CT-negative for stroke

Patients may have transient neurological symptoms at any time point

Device: CGX Systems Quick-20m

Patients with known stroke confirmed either on imaging or by stroke physician

Device: CGX Systems Quick-20m

Patients with no prior history of stroke

Device: CGX Systems Quick-20m

Interventions

CGX Systems Quick-20m 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.

Also known as: Portable EEG device

Patients with known stroke confirmed either on imaging or by stroke physician; Patients with no prior history of stroke; Patients with transient neurological symptoms and CT-negative for stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Dr. Mark I. Boulos - Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

Related Publications (7)

• 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.

  PMID: 35147656 BACKGROUND

• 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.

  PMID: 30507363 BACKGROUND

• 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.

  PMID: 11147987 BACKGROUND

• 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.

  PMID: 23871489 BACKGROUND

• 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.

  PMID: 22429809 RESULT

• 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.

  PMID: 31174955 RESULT

• 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.

  PMID: 30045636 RESULT

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Study Officials

• Mark Boulos, MD, MSc

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stroke Neurologist, Associate Professor, Associate Scientist, Principal Investigator

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: November 17, 2022
• Study Start: October 24, 2022
• Primary Completion: November 18, 2022
• Study Completion: November 18, 2022
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)