Traumatic Brain Injury in Veterans and Near-Infrared Phototherapy
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|ClinicalTrials.gov Identifier: NCT02635516|
Recruitment Status : Completed
First Posted : December 21, 2015
Last Update Posted : December 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|TBI (Traumatic Brain Injury)||Device: Near-Infrared Phototherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Principal Investigator:||Fred Grover, Jr., M.D.||RevolutionaryMD|