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CTRI Number  CTRI/2024/01/062065 [Registered on: 30/01/2024] Trial Registered Prospectively
Last Modified On: 05/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   To evaluate the performance of near infrared-based device in the management of traumatic brain injury patients.  
Scientific Title of Study   Feasibility Assessment of CEREBOⓇ in conjunction with CEREBOⓇ Research Unit (CCRU)to detect structural and functional injury among brain injury patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
IEC/RMC/2023/1061; Version/1;30/11/23  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vijaya Sekhar M V 
Designation  Head of Department 
Affiliation  Government General Hospital 
Address  Department of Neurosurgery Division - Neurosurgery First Floor Kakinada

East Godavari
ANDHRA PRADESH
533003
India 
Phone  9849115723  
Fax    
Email  nsvijayasekhar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vijaya Sekhar M V 
Designation  Head of Department 
Affiliation  Government General Hospital 
Address  Department of Neurosurgery Division - Neurosurgery First Floor Kakinada

East Godavari
ANDHRA PRADESH
533003
India 
Phone  9849115723  
Fax    
Email  nsvijayasekhar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vijaya Sekhar M V 
Designation  Head of Department 
Affiliation  Government General Hospital 
Address  Department of Neurosurgery Division - Neurosurgery First Floor Kakinada

East Godavari
ANDHRA PRADESH
533003
India 
Phone  9849115723  
Fax    
Email  nsvijayasekhar@gmail.com  
 
Source of Monetary or Material Support  
NA 
 
Primary Sponsor  
Name  Dr Vijaya Sekhar M V 
Address  Government General Hospital Kakinada Andhra Pradesh 533003 India 
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 Vijaya Sekhar  Rangaraya Medical College, Government General Hospital  Department of Neurosurgery, Division - Neurosurgery, First Floor Kakinada
East Godavari
ANDHRA PRADESH 		 9849115723

nsvijayasekhar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rangaraya Medical College Institutional Ethics Committee Cell  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S068||Other specified intracranial injuries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Near infrared based Device  Participants will be randomly allocated to the experimental and the control group. The experimental group would receive an additional scan using the CCRU device before proceeding to their standard care pathway. The results from the CCRU device would then be compared with the results of the standard CT or MRI scans to evaluate the effectiveness and accuracy of CCRU in detecting traumatic intracranial injuries. Outcomes such as sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio, as well as other relevant clinical outcomes (like time to diagnosis, impact on treatment decisions, etc.), would be collected and analyzed.  
Comparator Agent  Participants under going the usual standard of care  The control group would undergo the usual care pathway for suspected traumatic brain injury, which typically includes a clinical evaluation and a head CT or MRI scan as determined by the treating physicians judgment and existing clinical guidelines. Patients in the control group would not receive the CCRU scan. Their treatment and diagnosis would not be influenced by the data or results provided by the experimental device. The outcomes of the control group provide the baseline against which the experimental groups results are compared. 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Traumatic and non-traumatic patients who are referred for a head CT or an MRI scan.
2. Suspected CVA or infarct
 
 
ExclusionCriteria 
Details  1. History of neurosurgical procedure (e.g. decompressive craniectomy) with residual bone flap.
2. Post-Operative patients.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the structural and functional injury in traumatic brain injury patients   3 years 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in the mean transfer time from injury to first head CT Scan  3 years 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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 3 
Date of First Enrollment (India)   01/02/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This clinical study employs a quasi-experimental design with a randomized controlled trial to assess the efficacy of CEREBO® in conjunction with the CEREBO® Research Unit for traumatic brain injury management. The study will evaluate the clinical performance of the device in assessing structural and functional injuries in traumatic brain injury patients. Additionally, it will compare the reduction in transfer time to the first head CT scan between the experimental and control groups. The study also focuses on assessing the impact of early detection of brain injuries, thereby aiding in the development of tailored rehabilitation strategies. 
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