Clinical trial NCT02393079: Analysis of TCLT in TBI Patients: a Prospective, Randomized Controlled Trial
Official title: The Effects of Transcranial LED Therapy (TCLT) in Patients With Traumatic Brain Injury (TBI): a Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injury
Cognitive Deficits
Keywords: Traumatic Brain Injury
Cognitive
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evidence of improvement in inhibitory control measured by cognitive assessment (Stroop Test - Victoria Version) in patients undergoing intervention with an active LED helmet.
timeFrame: Three times: Up to one week before to start intervention, one week and three months after end the intervention
Secondary outcomes:
measure: 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.
timeFrame: Three times: Up to one week before to start intervention, one week and three months after end the intervention
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Clinics Hospital - University of Sao Paulo Medical School
state: SP
Study officials:
affiliation: Clinics Hospital - University of Sao Paulo Medical School
name: Wellingson S Paiva, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.