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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
The patients will undergo 18 sessions of repetitive transcranial LED stimulation.
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.
University of Sao Paulo General Hospital
São Paulo, São Paulo, Brazil
RECRUITINGImprovement of early and delayed functional outcome measured by Glasgow Outcome Scale Extended (GOSE).
Evaluation of improvement of early and delayed functional outcome measured by Glasgow Outcome Scale Extended (GOSE) after stimulation in comparison to the placebo group.
Time frame: Before stimulation and 1, 3 and 6 months after first stimulation
Improvement effects of transcranial LED in followup images measured by Marshall computed tomography scale and Adams grading scale for diffuse axonal injury.
Evaluation of early and delayed effects of Transcranial LED Therapy (TCLT) to improve followup computed tomography or magnetic resonance of DAI patients after Traumatic Brain Injury, measured by Marshal computed tomography scale, Adams grading scale for diffuse axonal injury and a protocol published by Hamdeh et al. (doi: 10.1089/neu.2016.4426) which graduates the magnitude of diffuse axonal lesion.
Time frame: Before stimulation and 1, 3 and 6 months after first stimulation
Hemodynamic improvement effect of transcranial LED measured by transcranial doppler (systolic and diastolic velocity of the left middle cerebral and basilar arteries, and the pulsatility index and resistance index values).
Improvement evaluation of effects of LED therapy in hemodynamic change through transcranial doppler, measuring systolic and diastolic velocity of the left middle cerebral and basilar arteries, and the pulsatility index and resistance index values.
Time frame: Before stimulation and 1, 3 and 6 months after first stimulation
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