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

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ClinicalTrials.gov Identifier: NCT03281759
Recruitment Status : Unknown
Verified August 2017 by University of Sao Paulo General Hospital.
Recruitment status was:  Recruiting
First Posted : September 13, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diffuse Axonal Brain Injury Traumatic Brain Injury Device: Transcranial LED Therapy (Active coil helmet) Device: Transcranial LED Therapy (Inactive coil helmet) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Transcranial LED Therapy on the Cognitive Rehabilitation for Diffuse Axonal Injury Due to Severe Acute Traumatic Brain Injury: Randomized Clinical Trial.
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : December 1, 2018

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Arms and Interventions
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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.


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


Secondary Outcome Measures :
  1. Improvement effects of transcranial LED in followup images measured by Marshall computed tomography scale and Adams grading scale for diffuse axonal injury. [ Time Frame: Before stimulation and 1, 3 and 6 months after first stimulation ]
    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.

  2. 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). [ Time Frame: Before stimulation and 1, 3 and 6 months after first stimulation ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281759


Contacts
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Contact: Joao G Santos, MD +5511941989876 joao.gustavo.rps@gmail.com
Contact: Wellingson S Paiva, PHD +5511975992245

Locations
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Brazil
University of Sao Paulo General Hospital Recruiting
São Paulo, SP, Brazil, 05401-000
Contact: Joao G Santos, MD    +5511941989876    joao.gustavo.rps@gmail.com   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Study Chair: Wellingson S Paiva, PhD University of Sao Paulo General Hospital
Principal Investigator: Joao G Santos, MD University of Sao Paulo General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03281759     History of Changes
Other Study ID Numbers: 15425
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Sao Paulo General Hospital:
Brain Injuries, Traumatic;
Diffuse Axonal Injury
Low-Level Light Therapy
 Neurologic Manifestations
Quality of Life
Rehabilitation
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Diffuse Axonal Injury
Brain Injuries, Diffuse
Wounds and Injuries
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System