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Traumatic Brain Injury in Veterans and Near-Infrared Phototherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02635516
Recruitment Status : Completed
First Posted : December 21, 2015
Last Update Posted : December 21, 2015
Sponsor:
Collaborators:
Tug McGraw Foundation
Colorado Neurological Institute
Information provided by (Responsible Party):
Cerehealth Corp.

Brief Summary:
This is a proof-of-concept study designed to demonstrate whether increases in cerebral blood flow, improvements in brain functioning, and reductions in symptomology associated with traumatic brain injury (TBI) can result from treatments consisting of near-infrared phototherapy (NIR).

Condition or disease Intervention/treatment Phase
TBI (Traumatic Brain Injury) Device: Near-Infrared Phototherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Mild and Moderate Traumatic Brain Injury in Veterans Using Near-Infrared Phototherapy
Study Start Date : April 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
Only one arm was used and this arm received Near-Infrared Phototherapy.
Device: Near-Infrared Phototherapy
The In Light Wellness Systems Near-Infrared Phototherapy Device (manufactured by In Light Wellness Systems, Inc.) contains alternating rows of 402 red (640 nm) and infrared (880 nm) light-emitting diodes embedded in 2 neoprene pads. One pad circles the skull, providing 720 Joules/min, and the other pad covers the top of the head, providing 360 joules/min. For each treatment session, the "A" setting on the 3-port controller is utilized, which runs approximately 6.7 min of 73 Hz, 587 Hz, and 1175 Hz in an automated sequential manner. No other interventions were utilized.
Other Name: Polychromatic Light Therapy




Primary Outcome Measures :
  1. Change in Cerebral Blood Flow [ Time Frame: Time1: Resting SPECT brain scan 2-14 days pre-treatment; Time2: Resting SPECT brain scan 1-4 weeks post-treatment. ]
    Single photon emission computed tomography (SPECT). To obtain this outcome measure, at pre- and post-treatment, a resting SPECT brain scan is performed as follows. Patient is placed in a comfortable reclining chair in a quiet room and an IV is started. Patient is allowed to acclimate in a quiet, semi-darkened room with eyes open and sound-dampening headphones on for 15 min, in accordance with the 2014 American College of Radiology Practice Guidelines. After 15 min., a dose of approximately 30 millicuries of Technetium-99m radiotracer is injected. SPECT scan is performed 60 min following injection by using a Siemens Symbia E SPECT gamma camera with low-energy high-resolution parallel hole collimators.

  2. Change in TBI Symptoms [ Time Frame: T1: 2-14 days prior to pre-treatment concentration brain scan; T2: 1-4 weeks post-treatment. ]
    Self-report TBI symptoms inventory composed of Likert-type items constructed to measure both frequency and intensity of 15 TBI symptoms.

  3. Change in Cognitive Functioning [ Time Frame: T1: 2-14 days prior to pre-treatment concentration brain scan; T2: 1-4 weeks post-treatment. ]
    Neuropsychological testing focused on the cognitive abilities frequently affected by TBI. Includes subscales of the Wechsler Adult Intelligence Scale IV.


Secondary Outcome Measures :
  1. Change in Cognitive Functioning 2 [ Time Frame: T1: 2-14 days prior to pre-treatment SPECT brain scan; T2: 1-4 weeks post-treatment. ]
    Neuropsychological testing focused on the cognitive abilities frequently affected by TBI. Includes subscales of the California Verbal Learning Test II.

  2. Change in Cognitive Functioning 3 [ Time Frame: T1: 2-14 days prior to pre-treatment SPECT brain scan; T2: 1-4 weeks post-treatment. ]
    Neuropsychological testing focused on the cognitive abilities frequently affected by TBI. Includes the Trail Making Test B.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participant is a military veteran.
  2. Able to read and sign the Informed Consent.
  3. Clinical history and diagnosis of TBI.
  4. Incident of TBI occurred at least 18 months or more prior to enrollment.
  5. Participant is willing and able to follow protocols for SPECT imaging procedure.
  6. SPECT scan shows evidence of TBI.

Exclusion Criteria:

  1. Participant is not a military veteran.
  2. Unable to read or sign the Informed Consent.
  3. No prior clinical indications of TBI.
  4. Participant is unwilling or unable to follow protocols for SPECT imaging procedure.
  5. SPECT scan shows no evidence of TBI.
  6. SPECT scan shows evidence of TBI but with significant comorbid neurological condition(s), which include active suicidal or homicidal ideation, psychosis, or repetitive expression of delusional ideation. In addition, any other psychiatric, neurological, orthopedic or cardiopulmonary condition that would preclude the ability of the subject to lie still for scan acquisition for 25-30 minutes and/or participate fully in the treatment regimen will result in exclusion from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635516


Sponsors and Collaborators
Cerehealth Corp.
Tug McGraw Foundation
Colorado Neurological Institute
Investigators
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Principal Investigator: Fred Grover, Jr., M.D. RevolutionaryMD
Publications:

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Responsible Party: Cerehealth Corp.
ClinicalTrials.gov Identifier: NCT02635516    
Other Study ID Numbers: 2014.01.01
First Posted: December 21, 2015    Key Record Dates
Last Update Posted: December 21, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified participant relevant demographic data will be reported. De-identified individual data analyses will be reported.
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System