Transcranial LED Therapy for Severe Acute Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03281759
• Other study ID #: 15425
• Status: Recruiting
• Phase: N/A
• First received: September 4, 2017
• Last updated: September 11, 2017
• Start date: October 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: August 2017
• Source: University of Sao Paulo General Hospital
• Contact: Joao G Santos, MD
• Phone: +5511941989876
• Email: joao.gustavo.rps[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Diffuse Axonal Brain Injury
• Diffuse Axonal Injury
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Device:
• Transcranial LED Therapy (Active coil helmet)
The patients will undergo 18 sessions of repetitive transcranial LED stimulation.
• 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.

Locations

Country	Name	City	State
Brazil	University of Sao Paulo General Hospital	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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