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
|
|
Primary Sponsor
|
Name |
Ajay Hegde |
Address |
Department of Neurosurgery,
Kasturba Medical College,
Manipal |
Type of Sponsor |
Other [Self] |
|
Details of Secondary Sponsor
|
|
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
|
|
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. |