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

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

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).

Study Overview

• Status: Completed
• Conditions: Brain Injury; Cognitive Deficits
• Intervention / Treatment: Device: Transcranial LED Therapy (TCLT); Device: Sham

Detailed 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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 054010-000
      • Clinics Hospital - University of Sao Paulo Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active helmet LED; 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); 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.
Sham Comparator: Sham group; 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; A SHAM identical helmet will be used in the control group.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Wellingson S Paiva, MD PhD, Clinics Hospital - University of Sao Paulo Medical School

Publications and helpful links

General Publications

• Poiani GDCR, Zaninotto AL, Carneiro AMC, Zangaro RA, Salgado ASI, Parreira RB, de Andrade AF, Teixeira MJ, Paiva WS. Photobiomodulation using low-level laser therapy (LLLT) for patients with chronic traumatic brain injury: a randomized controlled trial study protocol. Trials. 2018 Jan 8;19(1):17. doi: 10.1186/s13063-017-2414-5.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: February 20, 2015
• First Submitted That Met QC Criteria: March 13, 2015
• First Posted (Estimate): March 19, 2015

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 22, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Cognitive; Traumatic Brain Injury
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Neurocognitive Disorders; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Cognitive Dysfunction; Cognition Disorders
• Other Study ID Numbers: TCLT/DIP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No