Transcranial LED Therapy for Severe Acute Traumatic Brain Injury

Not Applicable

• Conditions: Diffuse Axonal Brain Injury; Traumatic Brain Injury
• Interventions: Device: Transcranial LED Therapy (Inactive coil helmet); Device: Transcranial LED Therapy (Active coil helmet)

• Registration Number: NCT03281759
• Lead Sponsor: University of Sao Paulo General Hospital

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).

Study Timeline

• Status Verified: 2017-08
• Study First Submitted: 2017-09-04
• Study First Submitted QC: 2017-09-11
• Last Update Submitted: 2017-09-11
• Study First Posted: 2017-09-13
• Last Update Posted: 2017-09-13
• Study Start: 2017-10-01
• Primary Completion: 2018-10-01
• Study Completion: 2018-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inactive Coil Helmet	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.
Active Coil Helmet	Transcranial LED Therapy (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.

Primary Outcome Measures

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

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

Trial Locations

Locations (1)

University of Sao Paulo General Hospital; 🇧🇷 São Paulo, SP, Brazil