Status:
UNKNOWN
Transcranial LED Therapy for Severe Acute Traumatic Brain Injury
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
Diffuse Axonal Brain Injury
Traumatic Brain Injury
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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 I...
Detailed 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...
Eligibility Criteria
Inclusion
- 1\) Patient victims of Traumatic Brain Injury with Glasgow Coma Scale ≤8 on admission:
- Head CT scan showing diffuse axonal lesion.
- CT scan without focal surgical lesions (Marshall I and II) and no signs of intracranial hypertension.
- Transcranial Doppler and optic nerve sheath US with no signs of intracranial hypertension.
- Admission less than 8 hours of trauma.
Exclusion
- History of drug or narcotic abuse.
- Emergence of surgical lesions or signs of intracranial hypertension in followup CTs.
- Transcranial Doppler or optic nerve sheath US presenting signs of intracranial hypertension.
- Psychiatric disorders.
- Injury severity score ≥3, according to the Abbreviated Injury Scale
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03281759
Start Date
October 1 2017
End Date
December 1 2018
Last Update
September 13 2017
Active Locations (1)
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1
University of Sao Paulo General Hospital
São Paulo, São Paulo, Brazil, 05401-000