Non-randomized, Open-labeled, Interventional, Single Group, Proof of Concept Study With Multi-modality Approach in Cases of Brain Death Due to Traumatic Brain Injury Having Diffuse Axonal Injury
Phase 1
Completed
- Conditions
- Brain Death
- Registration Number
- NCT02742857
- Lead Sponsor
- Bioquark Inc.
- Brief Summary
This is the proof of concept study with multi-modality approach (using intra-thecal bioactive peptides, stem cells, laser and transcranial IV laser and Median Nerve stimulation as adjuvants) in cases of brain death due to traumatic brain injury having diffuse axonal injury to document possibility of reversal of brain death (BD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Individuals declared Brain dead from a traumatic brain injury having diffuse axonal injury on MRI
- Not willing for organ donation
- Written informed consent from the legally acceptable representative of the patient
Exclusion Criteria
- Metallic clips/ metal implants or intracranial implants in the brain.
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Reversal of brain death as noted in clinical examination or EEG 15 days
- Secondary Outcome Measures
Name Time Method Cerebrospinal fluid (CSF) analysis of color consistency, cell counts, and microbial evaluation 15 days To signify any signs of aseptic or bacterial meningitis
MRI analysis to analyze any changes in meninges 15 days To signify any signs of aseptic or bacterial meningitis
O2 saturation 15 days Pulse 15 days Blood Pressure 15 days Respiration changes 15 days
Trial Locations
- Locations (1)
Anupam Hospital
🇮🇳Rudrapur, Uttaranchal, India
Anupam Hospital🇮🇳Rudrapur, Uttaranchal, India