Effects of transcranial LED therapy on the cognitive rehabilitation for diffuse axonal injury due to severe acute traumatic brain injury: study protocol for a randomized controlled trial

João Gustavo Rocha Peixoto Dos Santos, Ana Luiza Costa Zaninotto, Renato Amaro Zângaro, Ana Maria Costa Carneiro, Iuri Santana Neville, Almir Ferreira de Andrade, Manoel Jacobsen Teixeira, Wellingson Silva Paiva, João Gustavo Rocha Peixoto Dos Santos, Ana Luiza Costa Zaninotto, Renato Amaro Zângaro, Ana Maria Costa Carneiro, Iuri Santana Neville, Almir Ferreira de Andrade, Manoel Jacobsen Teixeira, Wellingson Silva Paiva

Abstract

Background: Photobiomodulation describes the use of red or near-infrared light to stimulate or regenerate tissue. It was discovered that near-infrared wavelengths (800-900 nm) and red (600 nm) light-emitting diodes (LED) are able to penetrate through the scalp and skull and have the potential to improve the subnormal cellular activity of compromised brain tissue. Different experimental and clinical studies were performed to test LED therapy for traumatic brain injury (TBI) with promising results. One of the proposals of this present study is to develop different approaches to maximize the positive effects of this therapy and improve the quality of life of TBI patients.

Methods/design: This is a double-blinded, randomized, controlled trial of patients with diffuse axonal injury (DAI) due to a severe TBI in an acute stage (less than 8 h). Thirty two patients will be randomized to active coil helmet and inactive coil (sham) groups in a 1:1 ratio. The protocol includes 18 sessions of transcranial LED stimulation (627 nm, 70 mW/cm2, 10 J/cm2) at four points of the frontal and parietal regions for 30 s each, totaling 120 s, three times per week for 6 weeks, lasting 30 min. Patients will be evaluated with the Glasgow Outcome Scale Extended (GOSE) before stimulation and 1, 3, and 6 months after the first stimulation. The study hypotheses are as follows: (1) transcranial LED therapy (TCLT) will improve the cognitive function of DAI patients and (2) TCLT will promote beneficial hemodynamic changes in cerebral circulation.

Discussion: This study evaluates early and delayed effects of TCLT on the cognitive rehabilitation for DAI following severe acute TBI. There is a paucity of studies regarding the use of this therapy for cognitive improvement in TBI. There are some experimental studies and case series presenting interesting results for TBI cognitive improvement but no clinical trials.

Trial registration: ClinicalTrials.gov, NCT03281759 . Registered on 13 September 2017.

Keywords: Brain diseases; Brain injuries; Central nervous system diseases; Craniocerebral trauma; Diffuse axonal injury; Low-level light therapy; Nervous system diseases; Neurologic manifestations; Quality of life; Trauma.

Conflict of interest statement

Authors’ information

The present protocol is JGRPS’s Ph.D. project. The study chair and tutor of the project is WSP.

Ethics approval and consent to participate

The present study was approved by the University of São Paulo General Hospital Ethical Institutional Review Board under protocol number 59930416.2.0000.0068. It will obtain informed consent from all the patients.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Template of content for the schedule of enrollment, interventions, and assessments from the LED TBI protocol. Baseline variables are evaluated before the intervention. The primary variable is evaluated 3 months after the intervention, and the secondary variables are evaluated during the whole period of this study. GOSE Glasgow Outcome Scale Extended
Fig. 2
Fig. 2
Study protocol flow diagram. Thirty patients who meet the inclusion and exclusion criteria will be recruited from the Emergency Department of University of São Paulo General Hospital. After baseline data collection, GOSE evaluation, transcranial Doppler hemodynamic measures, and CT scan, these patients will be randomized at a 1:1 ratio: active coil group vs sham coil group. They will be submitted to 18 sessions of TCLT three times per week and reevaluated with the aforementioned instruments after 1, 3, and 6 months after trauma

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