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 Details — Status: Completed

Administrative data

• NCT number: NCT02393079
• Other study ID #: TCLT/DIP
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: November 2019

Study information

• Verified date: April 2022
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Cognition Disorders
• Cognitive Deficits
• Cognitive Dysfunction

Intervention

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
A SHAM identical helmet will be used in the control group.

Locations

Country	Name	City	State
Brazil	Clinics Hospital - University of Sao Paulo Medical School	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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