| CTRI Number |
CTRI/2024/03/063435 [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
|
Clinical validation of CEREBO - a near-infrared spectroscopy (NIRS) device for traumatic intracranial hematoma detection in population older than 64 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 |
Head of Department, 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 |
Head of Department, 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 |
Head of Department, 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 |
Dept. of Neurosurgery NIMHANS, NIMHANS. Dr. MH Marigowda Road, Karnataka - 560029 |
| 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 |
| National Institute of Mental Health and Neuro Sciences IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S068||Other specified intracranial injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Head injury patients visiting the hospital 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 device 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="150"
Sample Size from India="150"
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
|
Timely identification and treatment of intracranial injuries in the elderly are vital to prevent rapid deterioration and improve outcomes. By potentially reducing diagnostic delays, CEREBO may offer substantial improvements in the standard care for elderly TBI patients, leading to better health outcomes and reduced healthcare burdens. This clinical study is designed to assess the performance of CEREBO, an intracranial injury detector, in the detection of traumatic intracranial injuries among individuals aged 65 years and older. The study will investigate the efficacy of CEREBO in a demographic with a higher risk of TBI complications. The results from CEREBO will be compared against head CT scans to determine accuracy and reliability in this specific age group. The primary aim is to improve the early detection of intracranial injuries. 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. |