Transcranial LED Therapy for Severe Acute Traumatic Brain Injury

NCT03281759 | Unknown DMC

• 1 other identifier: 15425
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diffuse Axonal Brain Injury; Traumatic Brain Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Active Coil Helmet

ACTIVE COMPARATOR

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.

Device: Transcranial LED Therapy (Active coil helmet)

Inactive Coil Helmet

PLACEBO COMPARATOR

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

Device: Transcranial LED Therapy (Inactive coil helmet)

Interventions

Transcranial LED Therapy (Active coil helmet) DEVICE

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

Active Coil Helmet

Transcranial LED Therapy (Inactive coil helmet) DEVICE

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.

Inactive Coil Helmet

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \) 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of Sao Paulo General Hospital

São Paulo, São Paulo, 05401-000, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 29690927 DERIVED

MeSH Terms

Conditions

Brain Injuries, Diffuse; Brain Injuries, Traumatic; Diffuse Axonal Injury; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wellingson S Paiva, PhD

  University of Sao Paulo General Hospital

  STUDY CHAIR

• Joao G Santos, MD

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joao G Santos, MD

CONTACT

+5511941989876; joao.gustavo.rps@gmail.com

Wellingson S Paiva, PHD

CONTACT

+5511975992245

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 13, 2017
• Study Start: October 1, 2017
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 13, 2017

Record last verified: 2017-08

Locations

BR (1)