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

Primary Purpose

Diffuse Axonal Brain Injury, Traumatic Brain Injury

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Transcranial LED Therapy (Active coil helmet)

Transcranial LED Therapy (Inactive coil helmet)

About this trial

This is an interventional treatment trial for Diffuse Axonal Brain Injury focused on measuring Brain Injuries, Traumatic;, Diffuse Axonal Injury, Low-Level Light Therapy, Neurologic Manifestations, Quality of Life, Rehabilitation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Sao Paulo General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active Coil Helmet

Inactive Coil Helmet

Arm Description

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.

The patients assigned to this group will undergo 18 sessions of transcranial LED but with an inactive coil, which will not generate LED emissions.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT03281759

First Posted

September 4, 2017

Last Updated

September 11, 2017

Sponsor

University of Sao Paulo General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03281759

Brief Title

Transcranial LED Therapy for Severe Acute Traumatic Brain Injury

Acronym

LED-TBI

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.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2017 (Anticipated)

Primary Completion Date

October 1, 2018 (Anticipated)

Study Completion Date

December 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diffuse Axonal Brain Injury, Traumatic Brain Injury

Keywords

Brain Injuries, Traumatic;, Diffuse Axonal Injury, Low-Level Light Therapy, Neurologic Manifestations, Quality of Life, Rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active Coil Helmet

Arm Type

Active Comparator

Arm Description

Arm Title

Inactive Coil Helmet

Arm Type

Placebo Comparator

Arm Description

The patients assigned to this group will undergo 18 sessions of transcranial LED but with an inactive coil, which will not generate LED emissions.

Intervention Type

Device

Intervention Name(s)

Transcranial LED Therapy (Active coil helmet)

Intervention Description

The patients will undergo 18 sessions of repetitive transcranial LED stimulation.

Intervention Type

Device

Intervention Name(s)

Transcranial LED Therapy (Inactive coil helmet)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Improvement of early and delayed functional outcome measured by Glasgow Outcome Scale Extended (GOSE).

Description

Evaluation of improvement of early and delayed functional outcome measured by Glasgow Outcome Scale Extended (GOSE) after stimulation in comparison to the placebo group.

Time Frame

Before stimulation and 1, 3 and 6 months after first stimulation

Secondary Outcome Measure Information:

Title

Improvement effects of transcranial LED in followup images measured by Marshall computed tomography scale and Adams grading scale for diffuse axonal injury.

Description

Time Frame

Before stimulation and 1, 3 and 6 months after first stimulation

Title

Description

Time Frame

Before stimulation and 1, 3 and 6 months after first stimulation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joao G Santos, MD

Phone

+5511941989876

joao.gustavo.rps@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Wellingson S Paiva, PHD

Phone

+5511975992245

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wellingson S Paiva, PhD

Organizational Affiliation

University of Sao Paulo General Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Joao G Santos, MD

Organizational Affiliation

University of Sao Paulo General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Sao Paulo General Hospital

City

São Paulo

State/Province

ZIP/Postal Code

05401-000

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joao G Santos, MD

Phone

+5511941989876

joao.gustavo.rps@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

29690927

Citation

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.

Results Reference

derived

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Transcranial LED Therapy for Severe Acute Traumatic Brain Injury

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