Traumatic Brain Injury in Veterans and Near-Infrared Phototherapy

NCT02635516 | Completed

• 1 other identifier: 2014.01.01
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

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).

Conditions

TBI (Traumatic Brain Injury)

Outcome Measures

Primary Outcomes (3)

• Change in Cerebral Blood Flow

  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.

  Time1: Resting SPECT brain scan 2-14 days pre-treatment; Time2: Resting SPECT brain scan 1-4 weeks post-treatment.

• Change in TBI Symptoms

  Self-report TBI symptoms inventory composed of Likert-type items constructed to measure both frequency and intensity of 15 TBI symptoms.

  T1: 2-14 days prior to pre-treatment concentration brain scan; T2: 1-4 weeks post-treatment.

• Change in Cognitive Functioning

  Neuropsychological testing focused on the cognitive abilities frequently affected by TBI. Includes subscales of the Wechsler Adult Intelligence Scale IV.

  T1: 2-14 days prior to pre-treatment concentration brain scan; T2: 1-4 weeks post-treatment.

Secondary Outcomes (2)

• Change in Cognitive Functioning 2

  T1: 2-14 days prior to pre-treatment SPECT brain scan; T2: 1-4 weeks post-treatment.

• Change in Cognitive Functioning 3

  T1: 2-14 days prior to pre-treatment SPECT brain scan; T2: 1-4 weeks post-treatment.

Study Arms (1)

Treatment

EXPERIMENTAL

Only one arm was used and this arm received Near-Infrared Phototherapy.

Device: Near-Infrared Phototherapy

Interventions

Near-Infrared Phototherapy DEVICE

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.

Also known as: Polychromatic Light Therapy

Treatment

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Participant is not a military veteran.
• Unable to read or sign the Informed Consent.
• No prior clinical indications of TBI.
• Participant is unwilling or unable to follow protocols for SPECT imaging procedure.
• SPECT scan shows no evidence of TBI.

Sponsors & Collaborators

• Cerehealth Corp.: lead
• Tug McGraw Foundation: collaborator
• Colorado Neurological Institute: collaborator

Related Publications (12)

• Abdel-Dayem HM, Abu-Judeh H, Kumar M, Atay S, Naddaf S, El-Zeftawy H, Luo JQ. SPECT brain perfusion abnormalities in mild or moderate traumatic brain injury. Clin Nucl Med. 1998 May;23(5):309-17. doi: 10.1097/00003072-199805000-00009.

  PMID: 9596157 BACKGROUND

• Fann JR, Burington B, Leonetti A, Jaffe K, Katon WJ, Thompson RS. Psychiatric illness following traumatic brain injury in an adult health maintenance organization population. Arch Gen Psychiatry. 2004 Jan;61(1):53-61. doi: 10.1001/archpsyc.61.1.53.

  PMID: 14706944 BACKGROUND

• Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL. Combat duty in Iraq and Afghanistan, mental health problems and barriers to care. US Army Med Dep J. 2008 Jul-Sep:7-17.

  PMID: 20088060 BACKGROUND

• Jacobs A, Put E, Ingels M, Put T, Bossuyt A. One-year follow-up of technetium-99m-HMPAO SPECT in mild head injury. J Nucl Med. 1996 Oct;37(10):1605-9.

  PMID: 8862291 BACKGROUND

• Jorge RE, Robinson RG, Moser D, Tateno A, Crespo-Facorro B, Arndt S. Major depression following traumatic brain injury. Arch Gen Psychiatry. 2004 Jan;61(1):42-50. doi: 10.1001/archpsyc.61.1.42.

  PMID: 14706943 BACKGROUND

• Kashluba S, Hanks RA, Casey JE, Millis SR. Neuropsychologic and functional outcome after complicated mild traumatic brain injury. Arch Phys Med Rehabil. 2008 May;89(5):904-11. doi: 10.1016/j.apmr.2007.12.029.

  PMID: 18452740 BACKGROUND

• Kennedy JE, Jaffee MS, Leskin GA, Stokes JW, Leal FO, Fitzpatrick PJ. Posttraumatic stress disorder and posttraumatic stress disorder-like symptoms and mild traumatic brain injury. J Rehabil Res Dev. 2007;44(7):895-920. doi: 10.1682/jrrd.2006.12.0166.

  PMID: 18075948 BACKGROUND

• Langlois JA, Rutland-Brown W, Wald MM. The epidemiology and impact of traumatic brain injury: a brief overview. J Head Trauma Rehabil. 2006 Sep-Oct;21(5):375-8. doi: 10.1097/00001199-200609000-00001.

  PMID: 16983222 BACKGROUND

• Lew HL. Rehabilitation needs of an increasing population of patients: Traumatic brain injury, polytrauma, and blast-related injuries. J Rehabil Res Dev. 2005 Jul-Aug;42(4):xiii-xvi. No abstract available.

  PMID: 16320135 BACKGROUND

• Nawashiro H, Wada K, Nakai K, Sato S. Focal increase in cerebral blood flow after treatment with near-infrared light to the forehead in a patient in a persistent vegetative state. Photomed Laser Surg. 2012 Apr;30(4):231-3. doi: 10.1089/pho.2011.3044. Epub 2011 Nov 2.

  PMID: 22047598 BACKGROUND

• Schiffer F, Johnston AL, Ravichandran C, Polcari A, Teicher MH, Webb RH, Hamblin MR. Psychological benefits 2 and 4 weeks after a single treatment with near infrared light to the forehead: a pilot study of 10 patients with major depression and anxiety. Behav Brain Funct. 2009 Dec 8;5:46. doi: 10.1186/1744-9081-5-46.

  PMID: 19995444 BACKGROUND

• Vaishnavi S, Rao V, Fann JR. Neuropsychiatric problems after traumatic brain injury: unraveling the silent epidemic. Psychosomatics. 2009 May-Jun;50(3):198-205. doi: 10.1176/appi.psy.50.3.198.

  PMID: 19567758 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Fred Grover, Jr., M.D.

  RevolutionaryMD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 21, 2015
• Study Start: April 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2015
• Last Updated: December 21, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will share