Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection in Traumatic Head Injury
Phase: NA
Conditions: Traumatic Brain Injury
Sponsor: National Institute of Mental Health and Neuro Sciences, India

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Title of the project 
Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma 
Detection in traumatic head injury 
 
 
 
NCT Number – Not Yet Available 
 
 
 
 
 
 
 
 
Date: September 19, 2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Format of research proposals to be submitted for ethical clearance 
1 Title of the project  
• Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection in traumatic head 
injury 
2 Investigating team with contact details (Mobile number of one or more investigators is a 
must)  
• Principal Investigator: Dr. DHAVAL SHUKLA, Prof. of Neurosurgery, NIMHANS. 
Mobile Phone no. +91 9898073843 
• Co-Investigator 1: Dr. SUBHAS KONAR, Asst. Prof. of Neurosurgery, NIMHANS. 
Mobile Phone no. +91 9986438181 
• Co-Investigator 2: Dr. B INDIRA DEVI, Prof. of Neurosurgery, NIMHANS. Mobile 
Phone no. +91 9480829601 
3 Funding details  
• Non-funded 
4 Introduction with brief review (not more than 250 words)  
• Traumatic brain injury is a common neurosurgical emergency managed in all tertiary and 
secondary hospital. Detecting the underlying pathology is major challenge specially for 
surgical cases. The outcome differs if early intervention was performed. Near Infra Red 
Spectroscopy [NIRS] based device will detect the hematoma at bedside or in ICU setting. 
Even the NIRS device can be use on trauma spot or in ambulance a with expert 
interpretation. Trehan, et al (1) performed the similar study in 100 patients in Indian 
subcontinent and found sensitivity of 58.46%, specificity of 42.86%. The negative 
predictive value was 35.71%. Salonia, et al (2) used the technology for detecting hematoma 
in 28 children and the sensitivity and specificity were 1.0 and 0.8. Brogan, et al (3) 
performed a metanalysis and reported sensitivity of 78% and specificity of 90 with a 
negative predictive value of 90%. Kahraman, et al (4) used the NIRS technology for 
detection of epidural and subdural hematoma and they found sensitivity of 0.87. So, the 
overall results of detection rate of hematoma using NIRS device is contradictory. It is not 
the replacement of CT scan but can help in triage. So, researchers are planning to do large 
scale prospective study to establish the role of NIRS device in detecting intracerebral 
hematoma and correlate the finding with CT scan finding. 
5 Statement of the problem (not more than 50 words)  
• There is a need for point of care diagnostic modalities for patients with head injury. A 
number of devices are being tested for the same like Brainscope, Blood Biomarkers, and 
NIRS based devices. Currently the NIRS based devices seem to be most promising but 
needs validation at multiple centers. 
6 Objectives of the study (not more than 100 words)  
• To evaluate detection rate of intracranial hematoma using NIRS device (Bioscan Research 
System®, Bioscan Research, Ahmedabad, India) in hospital. 
• To correlate the NIRS device finding with the Computer Tomography (CT) finding. 
• To detect clinically significant intracranial hematoma using NIRS device  
7 Methods - Give specific information on  
a) Participants:  
• Age range: 18-65 years 
• Number: 1000 
• Gender: All  

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• Inclusion criteria: 
o Acute head injury patients reaching our hospital.  
• Exclusion criteria: 
o Major scalp laceration or active bleeding. 
o Significant extracranial hematoma. 
o No consent from patient’s caretaker. 
• Method of selection: Consecutive patients 
• Source from which participants would come: Emergency Block of NIMHANS.  
b) Experimental procedure: 
• Tests to be administered: Near Infra-Red Scanning of head at bedside. 
• Time taken for testing: Two minutes 
• Biological samples collected: None 
• Frequency of testing/collection: Once 
• Risks for the participants while being tested: None 
• Methods of addressing the risk: Not Applicable 
c) Sequence of experiments, experimental procedure in brief and details of follow up.  
Patients with head injury 
 
Screening for inclusion criteria 
 
Routine CT scan and blood tests as indicated 
 
Near Infra-Red Scanning [NIRS] of head at bedside during the waiting time for routine tests and 
their results to detect intracranial hematoma [blood clot] at eight sites on head. 
Two frontal 
Two temporal 
Two parietal 
Two occipital 
 
Primary outcome 
Sensitivity of NIRS for detecting intracranial hematomas, where CT scan of head is considered 
as gold standard 
 
Secondary outcome 
Specificity, positive and negative predictive values of the NIRS device for detecting 
intracranial hematomas, where CT scan of head is considered as gold standard 
d) List out tests that would be carried out as part of the diagnostic procedures, and tests 
that would be carried out as part of the research program  
• Diagnostic Tests [all of these tests are routinely done for all patients with head 
trauma. None of these tests are additional for research project] 
o CT scan of head 
o Routine blood checkup for trauma patients 
o X-Ray and CT scans of other parts of body as indicated  
• Research Tests 
o Near Infra-Red Scanning of head at bedside 

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e) List out the payment details - tests for which the participants pay or do not pay.  
• Participants do not have to pay for research test 
• Participant have to pay for tests, which are required for clinical care 
 
8 Ethics: Please include here any ethical issues that are relevant / unique to this project. 
Please state whether ethics clearance has to come from any other institution. If this is a multi-
center study, please state the roles / responsibilities of different institutions in the project.  
• There are no ethical issues relevant/ unique to this project. The device is tested and declared 
safe. 
• No clearance is required from other institutes. 
• It is a single center study. 
 
Important references relating to the proposal.  
1. Trehan V, Maheshwari V, Kulkarni SV, Kapoor S, Gupta A. Evaluation of near infrared 
spectroscopy as screening tool for detecting intracranial hematomas in patients with traumatic 
brain 
injury. 
Med 
J 
Armed 
Forces 
India. 
2018 
Apr;74(2):139-142. 
doi: 
10.1016/j.mjafi.2017.08.009. Epub 2017 Nov 27. PubMed PMID: 29692479; PubMed Central 
PMCID: PMC5912115. 
 2. Salonia R, Bell MJ, Kochanek PM, Berger RP. The utility of near infrared spectroscopy in 
detecting intracranial hemorrhage in children. J Neurotrauma. 2012 Apr 10;29(6):1047-53. doi: 
10.1089/neu.2011.1890. Epub 2012 Jan 26. PubMed PMID: 22098538; PubMed Central PMCID: 
PMC3325547. 
3. Brogan RJ, Kontojannis V, Garara B, Marcus HJ, Wilson MH; Near-infrared spectroscopy 
(NIRS) to detect traumatic intracranial haematoma: A systematic review and meta-analysis. Brain 
Inj. 2017;31(5):581-588. doi: 10.1080/02699052.2017. 
4. Kahraman S, Kayali H, Atabey C, Acar F, Gocmen S. The accuracy of near-infrared 
spectroscopy in detection of subdural and epidural hematomas. J Trauma. 2006 Dec;61(6):1480-
3. PubMed PMID: 17159695.