TBI (Traumatic Brain Injury) Clinical Trial
Official title:
Treatment of Mild and Moderate Traumatic Brain Injury in Veterans Using Near-Infrared Phototherapy
Verified date | December 2015 |
Source | Cerehealth Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 13 |
Est. completion date | April 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 21 Years to 50 Years |
Eligibility |
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. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Cerehealth Corp. | Colorado Neurological Institute, Tug McGraw Foundation |
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. Review. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No |
Primary | 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. | No |
Primary | 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. | No |
Secondary | Change in Cognitive Functioning 2 | Neuropsychological testing focused on the cognitive abilities frequently affected by TBI. Includes subscales of the California Verbal Learning Test II. | T1: 2-14 days prior to pre-treatment SPECT brain scan; T2: 1-4 weeks post-treatment. | No |
Secondary | Change in Cognitive Functioning 3 | Neuropsychological testing focused on the cognitive abilities frequently affected by TBI. Includes the Trail Making Test B. | T1: 2-14 days prior to pre-treatment SPECT brain scan; T2: 1-4 weeks post-treatment. | No |
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