NCT03281759

Transcranial LED Therapy for Severe Acute Traumatic Brain Injury

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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 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).

Conditions

• Diffuse Axonal Brain Injury
• Traumatic Brain Injury

Interventions

Type	Name	Description
DEVICE	Transcranial LED Therapy (Active coil helmet)	The patients will undergo 18 sessions of repetitive transcranial LED stimulation.
DEVICE	Transcranial LED Therapy (Inactive coil helmet)	The patients assigned to this group will undergo 18 sessions of transcranial LED but with an inactive coil, which will not generate LED emissions, only a similar red light color.

Timeline

• Start date: 2017-10-01
• Primary completion: 2018-10-01
• Completion: 2018-12-01
• First posted: 2017-09-13
• Last updated: 2017-09-13

Locations

1 site across 1 country: Brazil