| CTRI Number |
CTRI/2024/03/063434 [Registered on: 01/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess the effectiveness of a Near Infrared Spectroscopy based Device - CEREBO to detect intracranial hematoma in traumatic brain injury in children less than 18 years of age |
|
Scientific Title of Study
|
NIRS in traumatic intracranial hematoma detection in traumatic head injury |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dhaval Shukla |
| Designation |
Professor of Neurosurgery |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Department of Neurosurgery, 2nd Floor, Neurosciences Faculty Center
Bangalore
KARNATAKA
560029
India |
| Phone |
9898073843 |
| Fax |
|
| Email |
neurodhaval@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhaval Shukla |
| Designation |
Professor of Neurosurgery |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Department of Neurosurgery, 2nd Floor, Neurosciences Faculty Center
Bangalore
KARNATAKA
560029
India |
| Phone |
9898073843 |
| Fax |
|
| Email |
neurodhaval@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhaval Shukla |
| Designation |
Professor of Neurosurgery |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Department of Neurosurgery, 2nd Floor, Neurosciences Faculty Center
Bangalore
KARNATAKA
560029
India |
| Phone |
9898073843 |
| Fax |
|
| Email |
neurodhaval@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Dhaval Shukla |
| Address |
Department of Neurosurgery, 2nd Floor, Neurosciences Faculty Center |
| 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 Dhaval Shukla |
National Institute of Mental Health & Neurosciences |
Department of Neurosurgery, 2nd Floor, Neurosciences Faculty Center
Bangalore
KARNATAKA |
9898073843
neurodhaval@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANSIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S000||Superficial injury of scalp, (2) ICD-10 Condition: S06||Intracranial injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Acute head injury and are referred for a head CT scan. |
|
| ExclusionCriteria |
| Details |
Major scalp laceration or active bleeding.
Significant extracranial hematoma.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sensitivity, Specificity and Accuracy of NIRS for detecting traumatic intracranial hematoma.
|
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the NIRS based device for continuous monitoring of TBI patients under conservative treatment. |
3 years |
| Usability parameters including but not limited to ease of use, scan time, etc. |
3 years |
|
|
Target Sample Size
|
Total Sample Size="91"
Sample Size from India="91"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2024 |
| 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
|
Early detection and timely treatment of intracranial injuries in children are crucial for improving outcomes and reducing long-term impacts of TBI. By potentially shortening the time to diagnosis and treatment, CEREBO may offer significant benefits in the management of pediatric TBI, thus contributing to better healthcare outcomes in this vulnerable population. This clinical trial aims to evaluate the performance of CEREBO, an innovative intracranial injury detector, in identifying traumatic intracranial injuries within the pediatric population aged 0 to 18 years. The study’s primary objective is to assess CEREBO’s efficacy and accuracy in early detection of intracranial injuries resulting from trauma. The study will involve pediatric patients who present with signs or risks of traumatic brain injury (TBI). CEREBO will be used to assess these patients, and its findings will be compared with the results of head CT scans, the current standard in intracranial injury diagnosis. The primary outcome of the study is to facilitate early detection of intracranial injuries Thus the study will provide critical data on the effectiveness of CEREBO in a pediatric setting and its potential role in transforming the current approach to TBI management in children. The study will also assess the efficacy of the NIRS device in continuous monitoring of TBI patients under conservative treatment. It will evaluate whether there exists a significant correlation between the NIRS data and the depth and volume of hematoma within the same subject. |