Transcranial LED Therapy for Severe Acute Traumatic Brain Injury (LED-TBI)

Effects of Transcranial LED Therapy on the Cognitive Rehabilitation for Diffuse Axonal Injury Due to Severe Acute Traumatic Brain Injury: Randomized Clinical Trial.

The purpose of this study is to evaluate early and delayed effects of Transcranial LED Therapy (TCLT) and determinate whether this therapy is effective for cognitive rehabilitation of Diffuse Axonal Injury patients after Traumatic Brain Injury.

Study Overview

• Status: Unknown
• Conditions: Traumatic Brain Injury; Diffuse Axonal Brain Injury
• Intervention / Treatment: Device: Transcranial LED Therapy (Active coil helmet); Device: Transcranial LED Therapy (Inactive coil helmet)

Detailed Description

This is a randomized clinical trial of patient with diffuse axonal injury (DAI) secondary to severe Traumatic Brain Injury in its acute stage (less than 8h). It will be recruited thirty adult patients who will receive thirty minutes at three times per week for 6 weeks (18 sessions) of transcranial stimulation. Fifteen of them will be stimulated with LED helmet and the rest with a sham helmet identical to the LED one, but only with a similar red light emission. Patient who meet inclusion criteria will be assessed with Glasgow Outcome Scale Extended (GOS-E) evaluation in at least five different periods (Admission, before and after each stimulation, and at 3 and 6 months later in outpatient followup).

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05401-000
      • Recruiting
      • University of Sao Paulo General Hospital
      • Contact: Joao G Santos, MD; Phone Number: +5511941989876; Email: joao.gustavo.rps@gmail.com

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:

1) Patient victims of Traumatic Brain Injury with Glasgow Coma Scale ≤8 on admission:

1. Head CT scan showing diffuse axonal lesion.
2. CT scan without focal surgical lesions (Marshall I and II) and no signs of intracranial hypertension.
3. Transcranial Doppler and optic nerve sheath US with no signs of intracranial hypertension.
4. Admission less than 8 hours of trauma.

Exclusion Criteria:

1. History of drug or narcotic abuse.
2. Emergence of surgical lesions or signs of intracranial hypertension in followup CTs.
3. Transcranial Doppler or optic nerve sheath US presenting signs of intracranial hypertension.
4. Psychiatric disorders.
5. Injury severity score ≥3, according to the Abbreviated Injury Scale

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Coil Helmet; The patients will undergo 18 sessions (627 nm, 70 mW/cm2, 10 J/cm2) at four points of the frontal and parietal region for 30 s each, totaling 120 s three times per week for 6 weeks, lasting 30 minutes of transcranial LED stimulation.	Device: Transcranial LED Therapy (Active coil helmet); The patients will undergo 18 sessions of repetitive transcranial LED stimulation.
Placebo Comparator: Inactive Coil Helmet; The patients assigned to this group will undergo 18 sessions of transcranial LED but with an inactive coil, which will not generate LED emissions.	Device: Transcranial LED Therapy (Inactive coil helmet); The patients assigned to this group will undergo 18 sessions of transcranial LED but with an inactive coil, which will not generate LED emissions, only a similar red light color.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of early and delayed functional outcome measured by Glasgow Outcome Scale Extended (GOSE).	Evaluation of improvement of early and delayed functional outcome measured by Glasgow Outcome Scale Extended (GOSE) after stimulation in comparison to the placebo group.	Before stimulation and 1, 3 and 6 months after first stimulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement effects of transcranial LED in followup images measured by Marshall computed tomography scale and Adams grading scale for diffuse axonal injury.	Evaluation of early and delayed effects of Transcranial LED Therapy (TCLT) to improve followup computed tomography or magnetic resonance of DAI patients after Traumatic Brain Injury, measured by Marshal computed tomography scale, Adams grading scale for diffuse axonal injury and a protocol published by Hamdeh et al. (doi: 10.1089/neu.2016.4426) which graduates the magnitude of diffuse axonal lesion.	Before stimulation and 1, 3 and 6 months after first stimulation
Hemodynamic improvement effect of transcranial LED measured by transcranial doppler (systolic and diastolic velocity of the left middle cerebral and basilar arteries, and the pulsatility index and resistance index values).	Improvement evaluation of effects of LED therapy in hemodynamic change through transcranial doppler, measuring systolic and diastolic velocity of the left middle cerebral and basilar arteries, and the pulsatility index and resistance index values.	Before stimulation and 1, 3 and 6 months after first stimulation

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Study Chair: Wellingson S Paiva, PhD, University of Sao Paulo General Hospital; Principal Investigator: Joao G Santos, MD, University of Sao Paulo General Hospital

Publications and helpful links

General Publications

• Santos JGRPD, Zaninotto ALC, Zangaro RA, Carneiro AMC, Neville IS, de Andrade AF, Teixeira MJ, Paiva WS. 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. Trials. 2018 Apr 24;19(1):249. doi: 10.1186/s13063-018-2632-5.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2017
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: September 4, 2017
• First Submitted That Met QC Criteria: September 11, 2017
• First Posted (Actual): September 13, 2017

Study Record Updates

• Last Update Posted (Actual): September 13, 2017
• Last Update Submitted That Met QC Criteria: September 11, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Rehabilitation; Quality of Life; Neurologic Manifestations; Low-Level Light Therapy; Brain Injuries, Traumatic;; Diffuse Axonal Injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Diffuse Axonal Injury; Brain Injuries, Diffuse
• Other Study ID Numbers: 15425

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No