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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Brain Injury, Cognitive Deficits

Intervention / Treatment
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* Device: Transcranial LED Therapy (TCLT)
* Device: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical and radiological diagnosis of traumatic brain injury Must be able to sign the Informed Consent Form Patients with TBI beginning three months after injury Exclusion Criteria: Impairment of language and / or limiting engine Extensive Cranial vault defects Presence of uncontrolled post-TBI epilepsy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active helmet LED<br>Description of the intervention: 18 patients will undergo 18 sessions of transcranial LED therapy (ACTIVE HELMET) with 30 minutes duration each. The sessions take place over 6 weeks. The therapy will be performed with a helmet that covers the frontal and parietal region. | Device: Transcranial LED Therapy (TCLT)<br>* Whereas the geometry of the skull and to uniformly distribute the light radiation, the TLTC is applied using as light source a set of LEDs installed in a helmet, emitting radiation in the range between 600nm and 650nm with a peak at 630nm, so in the red region.<br>|
| Sham Comparator: Sham group<br>Description of the intervention: 18 patients will undergo 18 sessions of transcranial LED therapy (INACTIVE HELMET) with 30 minutes duration each. The sessions take place over 6 weeks. The therapy will be performed with a helmet that covers the frontal and parietal region. | Device: Sham<br>* A SHAM identical helmet will be used in the control group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of improvement in inhibitory control measured by cognitive assessment (Stroop Test - Victoria Version) in patients undergoing intervention with an active LED helmet. | Measurement of each patient's inhibitory control by means of a test that causes them to cognitively suppress a habitual response in favor of a less habitual one. The results of patients with shorter response times indicate better positions in the tables, according to age. Examples of the average time (in seconds) of best results are between 17-29 years (11.79) and 80+ (19.31), any time longer than these indicates decreasing results. | Three times: Up to one week before to start intervention, one week and three months after end the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the immediate and late effects of the intervention on victims of moderate or severe TBI in the following cognitive domains: executive functioning, attentional processes and memory. | Apply a neuropsychological assessment battery focused on executive functioning, attentional processes and memory to measure the effects of the active led helmet compared to the use of the sham device. | Three times: Up to one week before to start intervention, one week and three months after end the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic Brain Injury, Cognitive