se of Advanced Magnetic Resonance Imaging (MRI)- a neuroimaging modality- for predicting functional outcome in severe traumatic brain injury
Not Applicable
Completed
- Conditions
- Health Condition 1: S060- ConcussionHealth Condition 2: S064- Epidural hemorrhageHealth Condition 3: S063- Focal traumatic brain injuryHealth Condition 4: S068- Other specified intracranial injuriesHealth Condition 5: S061- Traumatic cerebral edemaHealth Condition 6: S066- Traumatic subarachnoid hemorrhageHealth Condition 7: S065- Traumatic subdural hemorrhageHealth Condition 8: S069- Unspecified intracranial injury
- Registration Number
- CTRI/2019/04/018800
- Lead Sponsor
- IMHANS intramural funding
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
Inclusion Criteria
1) Severe TBI patients (GCS <8) either operated or non-operated and requiring neurointensive care unit admission (NICU) within 24 hours of injury
2) GCS < 8 or motor response < 5 during the first 4 days of NICU stay
4) Isolated TBI
Exclusion Criteria
1) Penetrating head injury
2) Associated extra-cranial injury
3) Patients who are hemodynamically unstable and requiring inotropic or vasoactive drugs
4) Patients on sedative infusions (thiopental sodium/propofol/midazolam)
5) Pregnant patients
6)Prior history of neurological or mental health disorders or patients on chronic medication
7)Patients with contraindications for MRI like pacemaker, metal implants or eye injury
8) Refusal of consent by patient’s care taker
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Whether EEG-fMRI, DTI and MRS done at 4-7 days after severe head injury are able to predict favorable (GOS 4-5) and unfavorable (GOS1-3) outcomes at 6 months and 1 year after injury <br/ ><br>2) Compare outcomes predicted by MR imaging tools with outcomes predicted by existing prognostication models (CRASH and IMPACT) <br/ ><br>Timepoint: 4-7 DAYS of ICU admission 1st MRI and Followup MRI at 3-6 months
- Secondary Outcome Measures
Name Time Method 1) Whether EEG-fMRI, DTI and MRS done at 4-7 days after severe head injury are able to predict favorable (GOS 4-5) and unfavorable (GOS1-3) outcomes at 6 months and 1 year after injury <br/ ><br>2) Compare outcomes predicted by MR imaging tools with outcomes predicted by existing prognostication models (CRASH and IMPACT) <br/ ><br>Timepoint: 4-7 DAYS of ICU admission 1st MRI and Followup MRI at 3-6 months