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Analysis of TCLT in TBI Patients: a Prospective, Randomized Controlled Trial

Brain Injury Clinical Trial

Official title:
The Effects of Transcranial LED Therapy (TCLT) in Patients With Traumatic Brain Injury (TBI): a Prospective, Randomized Controlled Trial

Clinical Trial Summary

The purpose of this study is to evaluate the early and late effects of Transcranial Led Therapy (TLTC) in memory and executive functions in patients with moderate and severe TBI history (TBI time longer than 3 months).

Clinical Trial Description

In the current study patients in the outpatient center - Neurotrauma Unit at University of São Paulo (HCFMUSP) diagnosed with moderate / severe blunt head trauma that meet the inclusion criteria will be divided randomly and blindly in two groups: Group A (n = 18) will receive stimulation through active helmet and Group B (n = 18) given placebo stimulation or sham through the inactive helmet. All patients will be subjected to 3 times of neuropsychological assessment: Study 1 (E1) - up to 4 weeks before the start of TLTC sessions; Study 2 (E2) - a week after the end of TLTC; and Study 3 (E3) - three months after the intervention. The evaluations will take in order to verify the early and late effects of TLTC in attention, memory and executive functions in patients with moderate and severe TBI. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02393079
Study type Interventional
Source University of Sao Paulo General Hospital
Contact
Status Completed
Phase N/A
Start date January 2015
Completion date November 2019
View Details
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