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

Arm | Intervention/treatment |
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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.
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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.
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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. |
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1) Patient victims of Traumatic Brain Injury with Glasgow Coma Scale ≤8 on admission:
- Head CT scan showing diffuse axonal lesion.
- CT scan without focal surgical lesions (Marshall I and II) and no signs of intracranial hypertension.
- Transcranial Doppler and optic nerve sheath US with no signs of intracranial hypertension.
- Admission less than 8 hours of trauma.
Exclusion Criteria:
- History of drug or narcotic abuse.
- Emergence of surgical lesions or signs of intracranial hypertension in followup CTs.
- Transcranial Doppler or optic nerve sheath US presenting signs of intracranial hypertension.
- Psychiatric disorders.
- Injury severity score ≥3, according to the Abbreviated Injury Scale

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
Contact: Joao G Santos, MD | +5511941989876 | joao.gustavo.rps@gmail.com | |
Contact: Wellingson S Paiva, PHD | +5511975992245 |
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 |
Study Chair: | Wellingson S Paiva, PhD | University of Sao Paulo General Hospital | |
Principal Investigator: | Joao G Santos, MD | University of Sao Paulo General Hospital |
Responsible Party: | University of Sao Paulo General Hospital |
ClinicalTrials.gov Identifier: | NCT03281759 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Brain Injuries, Traumatic; Diffuse Axonal Injury Low-Level Light Therapy |
Neurologic Manifestations Quality of Life Rehabilitation |
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 |