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CTRI Number  CTRI/2018/10/016184 [Registered on: 29/10/2018] Trial Registered Prospectively
Last Modified On: 26/10/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Wireless EEG to predict Neurological outcome in ICU 
Scientific Title of Study   Predicting clinical outcome in Neurosurgical ICU using quantitative uninterrupted real-time wireless EEG analysis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ajay Hegde 
Designation  Assistant Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Neurosurgery, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845876551  
Fax    
Email  dr.ajayhegde@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ajay Hegde 
Designation  Assistant Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Neurosurgery, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845876551  
Fax    
Email  dr.ajayhegde@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ajay Hegde 
Designation  Assistant Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Neurosurgery, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845876551  
Fax    
Email  dr.ajayhegde@gmail.com  
 
Source of Monetary or Material Support  
Self purchased 
 
Primary Sponsor  
Name  Ajay Hegde 
Address  Department of Neurosurgery, Kasturba Medical College, Manipal 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ajay Hegde  Kasturba Hospital  Room No 12, Department of Neurosurgery, Kasturba Medical College, Manipal
Udupi
KARNATAKA 
9845876551

dr.ajayhegde@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S00-S09||Injuries to the head,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients >18 years and <65 years.
2. Patients admitted to the neuro ICU within 12 hours of Moderate Head Injury. Glasgow Coma Scale (GCS) 8-12, Severe Head Injury GCS <8, Spontaneous ICH, Spontaneous SAH
 
 
ExclusionCriteria 
Details  1. Patients who have been subjected to a surgical procedure
2. Patients who have a planned surgical procedure within the following 6 hours
at admission.
3. Patients who are extremely restless and unable to maintain the headset. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
We will be performing a pilot study with 25 patients. Clinical data pertaining to heart rate, blood pressure, Glasgow coma scale (GCS) and pupillary measurements will be performed and recorded at hourly intervals as per existing protocols. Specific time-based events pertaining to clinical deterioration and other significant events (clinical improvement, death) would be identified and recorded.  Hourly monitoring of Heart Rate, Blood Pressure, GCS, Pupillary measurement will be done for the first 48 hours of the admission of the patient.  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   02/11/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Monitoring in the Neuro Intensive Care Unit (NICU) is mainly performed through the neurological examination. However, this may not be feasible in patients who are sedated and/or

mechanically ventilated(1). The ability to assess patient prognosis early in the course of hospital treatment facilitates clinical decision-making and permits accurate family counseling to impart realistic expectations for recovery. Several clinical and radiographic measures, Glasgow Coma Scale [GCS] score, pupil reactivity, age, lesions on early computed tomography [CT] scans) have significant predictive value when studied alone or in combination. All these are indirect parameters and occur at delayed intervals following the insult. Electroencephalogram is one modality similar to the Electrocardiogram (ECG) which can provide direct information about the electrical activity of the brain. EEG has been used to detect delayed neurological deterioration in subarachnoid hemorrhage but hasn’t been evaluated in traumatic brain injury and ICH.

Continuous electroencephalography (cEEG) is a non- invasive tool that can provide real-time measurement of electrical brain activity (5). EEG abnormalities arise when the normal cerebral blood flow (CBF) of 50 to 70 ml/100 g/min decreases to 25 to 30 ml/100 g/min. cEEG, therefore, provides a potential window of opportunity to therapeutically intervene

by detecting changes in cerebral perfusion prior to the point of irreversible damage (5-7).

transformation (compressed spectral array). In three studies that used this technique, various features were shown to correlate with DCI such as the trending of the total EEG power, relative alpha variability, and alpha–delta ratios (1) (8) (9). Changes on qCEEG were observed prior to Transcranial Doppler (TCD) abnormalities and preceded clinical deterioration up to 2 days (8) (9). Other selected characteristics of raw EEG, such as the back-ground rhythm and Synek scale, spontaneous variability and responsiveness stimulation, have been used to assist in estimating prognosis (2). The lack of P-Alpha variability over time during the initial three days after severe TBI was associated with clinical outcome at 1 month and 6 months (10,11). EEG power spectrum analysis has also been used to determine Intracranial pressure (12).

Muse- the brain sensing headband, is an electroencephalography (EEG) technology. Muse is used in hospitals, clinics, and universities worldwide as a research tool. The research domains extend from cognitive neuroscience, to brain health, psychotherapy, music cognition, and more. It provides an open platform where anyone can record raw data with Muse and anyone can build their own Muse application. EEG data can be recorded with MuseLab, MusePlayer, or via the third-party mobile application MuseMonitor (for Android and iOS). It is wireless (Bluetooth), lightweight, flexible, adjustable, and easily worn with less than one minute of set-up. Muse uses two channels on the left and two on the right, so it is ideal for exploring hemispheric asymmetries.

 
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