Glial Fibrillary Acidic Protein Testing and Handheld Near Infrared Spectroscopy Technology CEREBO in India.

CEREBO is an ICMR award winning point-of-care (POC) adjunct CT scanning device for detecting brain hematomas in patients with head injury. The study aims to validate the diagnostic accuracy of the PREDICT Assessment Model (CEREBO-NIRS plus GFAP/D-Dimer POC Assay) in patients with suspected stroke. The study will be conducted as part of the Indian Council of Medical Research's National Health Research Priority (ICMR-NHRP) under the INDIA-EMS project using a two phase design. PHASE I: Validation of a diagnostic accuracy and feasbility of PREDICT assessment model (a combined approach using GFAP/ D-dimer POC lateral flow assay plus CEREBO-NIRS technology). Study Design: Prospective, Multicenter, Validation and Feasibility Study. PHASE II: Pilot RCT to assess integration of the PREDICT assessment model into pre-hospital pathways. Study Design: Pilot Randomized Controlled Trial (RCT) (Year 3-5)

Phase 1 Inclusion criteria * Adult patients of any gender ≥18 years with clinically suspected stroke * Transported by ambulance or presenting directly to ED of participating hospitals * Time from symptom onset/ Lost known well time (within 24 hours) * Consent provided by patient/ next of kin Exclusion criteria: * Patients with known pre-existing neurological conditions that may confound diagnosis (Concurrent traumatic brain injury, recent TBI in last 3months, IS/ICH in last 3 months, Diagnosis of brain tumour/SOL) * Patients with known medical condition with estimated life expectancy ≤ 3 months * Those refusing consent Phase 2 Inclusion criteria: * Adult patients of any gender ≥18 years with clinically suspected stroke * Transported by ambulance to ED of participating hospitals * Time from symptom onset/ Last well known time (≤ 24 hours) * NIHSS ≥ 5 * Consent provided by patient/ next of kin Exclusion criteria: * Patients with known pre-existing neurological conditions that may confound diagnosis (Concurrent traumatic brain injury, recent TBI in last 3months, IS/ ICH in last 3 months, Diagnosis of brain tumour/ SOL) * Patients with known medical condition with estimated life expectancy ≤ 3 months * Those refusing consent