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Trial registered on ANZCTR
Registration number
ACTRN12611000611921
Ethics application status
Approved
Date submitted
10/06/2011
Date registered
15/06/2011
Date last updated
13/12/2011
Type of registration
Prospectively registered
Titles & IDs
Public title
Quantitative Electroencephalography in Stroke
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Scientific title
Role of Quantitative Electroencephalography (EEG) in diagnosis, prognostication and management of Acute Stroke
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Secondary ID [1]
262359
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None
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Universal Trial Number (UTN)
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Trial acronym
QuESt
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ischaemic stroke
268062
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Hemorrhagic Stroke
268063
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Condition category
Condition code
Stroke
268206
268206
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0
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Ischaemic
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Stroke
268207
268207
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0
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Haemorrhagic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
QEEG Recording
Nineteen electrode (10–20 system) standard clinical EEG will be performed. This will be done using a cap for convenient and accurate placement of sensors (electrodes) as we have used in the past stroke EEG studies at the RBWH. The “NicoletOne ICU Brain Monitor” EEG System (CareFusion Healthcare) will be used. This system is currently a leading clinical EEG system in the global market. EEG data will be recorded into a hard drive installed in this system. With this EEG system, the electrodes can be connected to a portable wireless device which would facilitate patient movement and comfort. The acute recording duration will be from 30 minutes minimum to 6 hours maximum depending upon factors such as treatment, stroke severity and an individual patient's comfort. The expected median acute EEG recording time per patient will be 2 hours across all patients. A subacute EEG will be performed at 72 +/-4 hours. Its duration will be up to 30 minutes at maximum. It is endeavoured to ensure that recording of EEG is carried out in an absolutely conducive manner without causing any alterations or delay to the standard of care of the participants. This will enhance the research aim of supporting the complementary nature of this vital investigative tool.
QEEG Analysis
We will apply the same quantified EEG analysis methods that we have in past published studies (e.g., Finnigan et al., 2004; 2007). In addition the QEEG “brain symmetry index” will be calculated precisely as per the published methods of Sheorajpanday and colleagues (2010). These analyses will be performed “offline”, subsequent to end of the EEG recording. These will be performed in a blinded manner; that is, the investigator performing the QEEG analyses will be blinded to patient outcomes and stroke type.
Clinical Assessments
Patients’ clinical assessments will be performed at the initial presentation, at day 5-7, at discharge (if later than a week) and at a 3 month (approximately) follow up. This will be done using the universally used (both in clinical practice and stroke research) NIHSS. In addition the patients will be assessed on modified Rankin Scale {mRS; (Rankin 1957)} as well as Barthel Index {BI; (Mahoney 1965)} at the 3 month follow up appointment. These assessments (initial as well as at the 3 – moth follow up) are an integral part of the routine evaluation of stroke patients.
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Intervention code [1]
266752
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Early detection / Screening
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Intervention code [2]
266753
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Diagnosis / Prognosis
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Comparator / control treatment
Not applicable
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Stroke Severity (National Institute of Health Stroke Scale - NIHSS)
Morbidity and mortality (Barthel Index - BI, Modified Rankin Scale - mRS) - on a 3 month follow up appointment (or chart review).
mRS measures death as well.
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Assessment method [1]
268954
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Timepoint [1]
268954
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Three months
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Primary outcome [2]
268955
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Stroke Severity (NIHSS), Morbidity and Mortality (mRS) - again as documented in the medical records and as assessed by the investigators.
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Assessment method [2]
268955
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Timepoint [2]
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72 +/- 4 hours, Discharge
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Primary outcome [3]
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Stroke Severity (NIHSS)
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Assessment method [3]
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Timepoint [3]
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At presentation
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Secondary outcome [1]
276706
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Radiological characteristics of the stroke (as analysed in routine medical imaging investigations of the stroke during hospitalization)
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Assessment method [1]
276706
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Timepoint [1]
276706
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At Presentation
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Eligibility
Key inclusion criteria
Patient presenting with acute stroke within 24 hours of onset of symptoms
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients under 18 years of age (RBWH primarily treats adult patients and data of use of EEG in stroke patients < 18 years of age is limited)
Pregnant patients (use of various investigations e.g., CT and treatments e.g., thrombolysis is limited in pregnancy)
Patients with previous craniotomy affecting the EEG electrode placement and signal recording
Any participant who is unable to (or declines to) consent for any reason or for whom consent from a substitute decision maker is unavailable or declined.
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients presenting with developing symptoms and/or signs of focal loss of cerebral function suggestive of stroke presenting within 24 hours of symptom onset will be potential participants of this study. Stroke onset will be defined as the last time patient was known without neurological deficit. In case of “wake-up strokes” (where patients present after waking up with symptoms of stroke), the time of onset will be defined as the mid-point between the patient went to bed and the time patient woke up.
Time of onset of symptoms, medical history (past as well as that of the current event), and current medications as well as physical and neurological assessment will be reviewed. Results of routine blood tests and crucially any available results of routine brain imaging will be analysed. If the patient is considered eligible on the basis of these, they will be invited to participate in the trial by the medical and research staff of the stroke unit.
Stroke team clinicians will approach the potential participants (or their substitute decision makers) and in addition to describing the standard clinical care, this research will be explained in detail including: EEG electrode application in particular and study assessments, risks, benefits, responsibilities and any time burdens of participation in general. They will be informed that (1) routine physiological data e.g., blood pressure, pulse etc. (2) results of any blood and radiological investigations and (3) any necessary information from their General Practitioner’s medical records would be recorded and analysed. They will be given a written information sheet to read. They will be given an ample time to discuss the study with family and make a decision whether to participate or not. They will be given the opportunity to ask and have questions answered. If agreeable to participate and after satisfactorily answering all queries they will be requested to sign a consent form.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/07/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
120
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
267236
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Hospital
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Name [1]
267236
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Stroke Unit Research Fund
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Address [1]
267236
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Department of Neurosciences
Level 7
Ned Hanlon Building
Royal Brisbane & Women's Hospital
Herston
QLD 4029
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Country [1]
267236
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Australia
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Primary sponsor type
Hospital
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Name
Royal Brisbane & Women's Hospital
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Address
Department of Neurosciences
Level 7
Ned Hanlon Building
Royal Brisbane & Women's Hospital
Herston
QLD 4029
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Country
Australia
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Secondary sponsor category [1]
266301
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None
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Name [1]
266301
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Address [1]
266301
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Country [1]
266301
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Other collaborator category [1]
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Individual
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Name [1]
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Dr. Simon Finnigan
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Address [1]
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UQ Centre of Clinica Research
Royal Brisbane & Women's Hospital
Herston
QLD 4029
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Country [1]
252061
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
269227
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RBWH Human Research Ethics Committee
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Ethics committee address [1]
269227
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Human Research Ethics Office
Level 7, Block 7
Royal Brisbane and Women's Hospital
Herston QLD 4029
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Ethics committee country [1]
269227
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Australia
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Date submitted for ethics approval [1]
269227
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19/04/2011
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Approval date [1]
269227
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Ethics approval number [1]
269227
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HREC/11/QRBW/162
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Summary
Brief summary
Stroke is a leading cause of death, disability and huge socio-economic burden. It is caused by reduced blood supply (acute ischaemic stroke = AIS) or bleeding in the brain (intracerebral haemorrhage = ICH). Clinical prognosis and management in the acute post-stroke period are vitally informed by neurological assessment and accurate characterisation of brain injury. It is known that stroke-affected brain regions generate abnormal electrical signals which can be detected with electroencephalography (EEG) using electrodes placed non-invasively on the head. Quantitative analyses of EEG (QEEG) have been utilised over the past decade in stroke and other patients. EEG has a significant advantage in that it is virtually without contraindication or side effects and can be continuously performed at the bedside. This enables QEEG to monitor response to treatments as well; especially in consonance with the current brain imaging techniques. However, despite mounting evidence, QEEG surprisingly remains relatively under-utilised in acute stroke patients. An apparent reason for this is that it is unclear which parameter(s) is able to predict the patient’s clinical outcome most precisely and; whether this varies with stroke sub-type or timing of EEG. Broadly, this research is intended to identify the optimal QEEG parameters (timing, frequency/amplitude vs. interhemispheric symmetry measures) for prognostication in AIS & ICH.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
32731
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Address
32731
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Country
32731
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Phone
32731
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Fax
32731
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Email
32731
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Contact person for public queries
Name
15978
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Dr. Nabeel Sheikh
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Address
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Department of Neurosciences
Level 7
Ned Hanlon Building
Royal Brisbane & Women's Hospital
Herston
QLD 4122
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Country
15978
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Australia
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Phone
15978
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+61 7 3636 8111
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Fax
15978
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+61 7 3636 7675
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr. Nabeel Sheikh
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Address
6906
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Department of Neurosciences
Level 7
Ned Hanlon Building
Royal Brisbane & Women's Hospital
Herston
QLD 4122
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Country
6906
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Australia
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Phone
6906
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+61 7 3636 8111
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Fax
6906
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+61 7 3636 7675
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Email
6906
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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