Effects of Transcranial LED Therapy on the Cognitive Rehabilitation for Diffuse Axonal Injury Due to Severe Acute Traumatic Brain Injury: Randomized Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Improvement of early and delayed functional outcome measured by Glasgow Outcome Scale Extended (GOSE).
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Transcranial LED Therapy (Active coil helmet) (Device)
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.
Intervention: Transcranial LED Therapy (Inactive coil helmet) (Device)
Outcomes
Primary Outcomes
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 Outcomes
- 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)
- 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)