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CompletedNCT05189561Updated Mar 3, 2022

Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection

An interventional study of near-infrared scanner in Traumatic Brain Injury, sponsored by National Institute of Mental Health and Neuro Sciences, India. Completed at 1 site in India. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-03-03.

Sponsored by National Institute of Mental Health and Neuro Sciences, India · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
208
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Traumatic brain injury is a common neurosurgical emergency managed in all tertiary and secondary hospitals. Detecting the underlying pathology is a major challenge especially for surgical cases. The outcome differs if the early intervention is performed. Near-infrared spectroscopy (NIRS) based device will detect the hematoma at the bedside. It is not the replacement of a CT scan but can help in triage. This is a large-scale prospective study to establish the role of NIRS device in detecting intracerebral hematoma and correlate the finding with CT scan finding.

Read the detailed description

The light used in the near-infrared spectrum, especially between 700 and 1000 nm, is able to penetrate the human tissue 'optical window'. Once the light has penetrated into the tissue, it is either scattered or absorbed. Light is mostly scattered by bones, skin and cerebral white matter. However, red blood cells, which represent roughly have a low scattering effect and high absorption. Utilising this principle, the emitter and detector could be used to measure the light scattered by the tissues. The 'optical density' of the tissue is calculated and by comparing the left and right hemispheres in the eight contralateral locations of the brain lobes where lesions with extravascular accumulation of haemoglobin can be detected. A NIRS device named Cerebo® was developed by Bioscan Research, Ahmedabad, India. It is a low power non risky device that can screen the patient's head multiple times without causing any side effect. The built in safety features in Cerebo® make it fail safe system for intentional as well as accidental exposure to laser beam. The average power and total power dissipation is very low. The system poses no risk to the patients who will be included in the study.

So far the overall results of detection rate of hematoma using NIRS device are contradictory. It is not the replacement of a CT scan but can help in triage. In the present research the investigators plan to do a large scale prospective study to establish the role of NIRS device in detecting intracerebral hematoma and correlate the finding with CT scan findings.

02

Conditions studied

  • Traumatic Brain Injury

Keywords

  • traumatic brain injury
  • traumatic intracranial hematoma
  • extradural hematoma
  • subdural hematoma
  • cerebral contusion
  • near-infrared spectroscopy
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Acute traumatic brain injury patients reaching the hospital

Exclusion criteria

Exclusion Criteria:

  • Major scalp laceration or active bleeding.
  • Significant extracranial hematoma.
04

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
208 participants (actual)

Study arms

  • Experimental
    Cerebo®

    Participants undergoing scanning using NIRS device.

    Other: near-infrared scanner

Interventions

  • Othernear-infrared scanner

    Tests to be administered: Near Infra-Red Scanning of the head at the bedside. Time taken for testing: Two minutes Biological samples collected: None Frequency of testing/collection: Once Risks for the participants while being tested: None

    Also known as: Cerebo

05

What researchers measure

Primary outcomes

  1. Detection rate of intracranial hematoma

    To evaluate detection rate of intracranial hematoma using NIRS device Cerebo®, (Bioscan Research, Ahmedabad, India) in hospital.

    Time frame: Immediately after the test

Secondary outcomes

  1. Detection rate of clinically significant intracranial hematoma

    To evaluate detection rate of clinically significant intracranial hematoma using NIRS device Cerebo®, (Bioscan Research, Ahmedabad, India), which requires admission or surgical intervention.

    Time frame: Immediately after the test

06

Study locations

1 site
  • NIMHANS
    Bangalore, KA 560029, India
07

References and documents

Study documents

  • Study protocol · Sep 19, 2020

Documents are hosted by the registry — open the source record to download them.

08

Registry details

Key details

Study ID
NCT05189561
Lead sponsor
National Institute of Mental Health and Neuro Sciences, India
Responsible party
Dhaval Shukla (Prof. of Neurosurgery, National Institute of Mental Health and Neuro Sciences, India) — Principal investigator
First posted
Jan 12, 2022
Start date
Aug 24, 2021
Primary completion
Oct 31, 2021
Completion
Oct 31, 2021
Last update
Mar 3, 2022

Study contacts

Dhaval Shukla, MCh
principal investigator · National Institute of Mental Health and Neuro Sciences, India

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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