Evaluation of novel technique to detect intracranial bleed after head injury

Not yet recruiting

Conditions: Other specified intracranial injuries,

Registration Number: CTRI/2023/03/050964

Lead Sponsor: INMAS - Defence Research and Development Organisation

Brief Summary: Traumatic Brain Injury (TBI) is a potentially fatal and debilitating condition that can cause long-term physical and cognitive impairments even if the patient survives. The prognosis deteriorates significantly with time, thus early detection and timely intervention is essential. Current clinical diagnostic tools are insufficient and there is an increasing need for a quick, accurate, and affordable computer-aided method that can collect the features of hematoma and provide early diagnosis.

The novel mNIRS is a triaging tool that detects traumatic intracranial hemorrhage objectively. The present study evaluates its performance by clinically estimating its efficacy in detecting the intractranial hemorrhage in comparison to the head CT scans

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 142

Inclusion Criteria

Participants with a suspected head injury and referred for a head CT scan.

Exclusion Criteria

Major scalp laceration, active bleeding, significant extracranial hematoma or skull abnormality, or any other condition that would not allow device placement, participants with a history of brain surgery or neurologic disease and pregnant women.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Parameters Sensitivity, Specificity and Accuracy of the novel mNIRS (CEREBO) to detect traumatic intracranial hemorrhages in suspected head injury cases	3 years

Secondary Outcome Measures

Name	Time	Method
To identify the design refinements for better usability for defence deployment	3 years

Trial Locations

Locations (1): Dr Ram Manohar Lohia Hospital
🇮🇳
Delhi, DELHI, India
Dr Ram Manohar Lohia Hospital
🇮🇳Delhi, DELHI, India
Dr Ajay Choudhary
Principal investigator
9312458450
mmathew.inmas@gov.in