CompletedPhase 1

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

India20 participantsStarted 2016-07

Plain-language 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).

Who can participate

Age range15 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Reversal of brain death as noted in clinical examination or EEG

Timeframe: 15 days

Trial details

NCT IDNCT02742857

SponsorBioquark Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-08

View on ClinicalTrials.gov More Brain Death trials