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Transcranial LED Therapy for Severe Acute Traumatic Brain Injury — LED-TBI  

Traumatic Brain Injury Clinical Trial

Official title:
Effects of Transcranial LED Therapy on the Cognitive Rehabilitation for Diffuse Axonal Injury Due to Severe Acute Traumatic Brain Injury: Randomized Clinical Trial.

Clinical Trial Summary

The purpose of this study is to evaluate early and delayed effects of Transcranial LED Therapy (TCLT) and determinate whether this therapy is effective for cognitive rehabilitation of Diffuse Axonal Injury patients after Traumatic Brain Injury.

Clinical Trial Description

This is a randomized clinical trial of patient with diffuse axonal injury (DAI) secondary to severe Traumatic Brain Injury in its acute stage (less than 8h). It will be recruited thirty adult patients who will receive thirty minutes at three times per week for 6 weeks (18 sessions) of transcranial stimulation. Fifteen of them will be stimulated with LED helmet and the rest with a sham helmet identical to the LED one, but only with a similar red light emission. Patient who meet inclusion criteria will be assessed with Glasgow Outcome Scale Extended (GOS-E) evaluation in at least five different periods (Admission, before and after each stimulation, and at 3 and 6 months later in outpatient followup). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03281759
Study type Interventional
Source University of Sao Paulo General Hospital
Contact Joao G Santos, MD
Phone +5511941989876
Email joao.gustavo.rps@gmail.com
Status Recruiting
Phase N/A
Start date October 1, 2017
Completion date December 1, 2018
View Details
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