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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
Scientific title
Role of Quantitative Electroencephalography (EEG) in diagnosis, prognostication and management of Acute Stroke
Secondary ID [1] 262359 0
None
Universal Trial Number (UTN)
Trial acronym
QuESt
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischaemic stroke 268062 0
Hemorrhagic Stroke 268063 0
Condition category
Condition code
Stroke 268206 268206 0 0
Ischaemic
Stroke 268207 268207 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 266752 0
Early detection / Screening
Intervention code [2] 266753 0
Diagnosis / Prognosis
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 268954 0
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.
Timepoint [1] 268954 0
Three months
Primary outcome [2] 268955 0
Stroke Severity (NIHSS), Morbidity and Mortality (mRS) - again as documented in the medical records and as assessed by the investigators.
Timepoint [2] 268955 0
72 +/- 4 hours, Discharge
Primary outcome [3] 268965 0
Stroke Severity (NIHSS)
Timepoint [3] 268965 0
At presentation
Secondary outcome [1] 276706 0
Radiological characteristics of the stroke (as analysed in routine medical imaging investigations of the stroke during hospitalization)
Timepoint [1] 276706 0
At Presentation

Eligibility
Key inclusion criteria
Patient presenting with acute stroke within 24 hours of onset of symptoms
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267236 0
Hospital
Name [1] 267236 0
Stroke Unit Research Fund
Country [1] 267236 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane & Women's Hospital
Address
Department of Neurosciences
Level 7
Ned Hanlon Building
Royal Brisbane & Women's Hospital
Herston
QLD 4029
Country
Australia
Secondary sponsor category [1] 266301 0
None
Name [1] 266301 0
Address [1] 266301 0
Country [1] 266301 0
Other collaborator category [1] 252061 0
Individual
Name [1] 252061 0
Dr. Simon Finnigan
Address [1] 252061 0
UQ Centre of Clinica Research
Royal Brisbane & Women's Hospital
Herston
QLD 4029
Country [1] 252061 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269227 0
RBWH Human Research Ethics Committee
Ethics committee address [1] 269227 0
Ethics committee country [1] 269227 0
Australia
Date submitted for ethics approval [1] 269227 0
19/04/2011
Approval date [1] 269227 0
Ethics approval number [1] 269227 0
HREC/11/QRBW/162

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32731 0
Address 32731 0
Country 32731 0
Phone 32731 0
Fax 32731 0
Email 32731 0
Contact person for public queries
Name 15978 0
Dr. Nabeel Sheikh
Address 15978 0
Department of Neurosciences
Level 7
Ned Hanlon Building
Royal Brisbane & Women's Hospital
Herston
QLD 4122
Country 15978 0
Australia
Phone 15978 0
+61 7 3636 8111
Fax 15978 0
+61 7 3636 7675
Email 15978 0
Nabeel_Sheikh@health.qld.gov.au
Contact person for scientific queries
Name 6906 0
Dr. Nabeel Sheikh
Address 6906 0
Department of Neurosciences
Level 7
Ned Hanlon Building
Royal Brisbane & Women's Hospital
Herston
QLD 4122
Country 6906 0
Australia
Phone 6906 0
+61 7 3636 8111
Fax 6906 0
+61 7 3636 7675
Email 6906 0
Nabeel_Sheikh@health.qld.gov.au

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.