TBI (Traumatic Brain Injury)NCT02635516
Traumatic Brain Injury in Veterans and Near-Infrared Phototherapy
A study testing Near-Infrared Phototherapy in people with TBI (Traumatic Brain Injury), run by Cerehealth Corp..
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 50 years, men only
- Conditions the study is for
- TBI (Traumatic Brain Injury)
- What is being tested?
- Near-Infrared Phototherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
About this study
Official title: Treatment of Mild and Moderate Traumatic Brain Injury in Veterans Using Near-Infrared Phototherapy
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).
Read the detailed description
The incidence of traumatic brain injury is widespread. The Centers for Disease Control estimate that 1.7 million TBIs occur each year and that TBI is a contributing factor in about 30% of all injury-related deaths. In addition, about 75% of these TBIs are concussions, or mild TBIs (mTBI). However, such concussions, especially multiple concussions that occur over time, are not harmless. The damage of even mild TBI can potentially lead to neuropsychiatric sequelae. Moreover, injury to the brain can worsen over time depending on the degree of inflammatory response and the areas of injury. TBI induces a number of neuropathological changes like aggregation of beta amyloid and tau proteins along with neuroinflammatory changes that resemble the pathology of degenerative diseases.
For many of our returning Veterans, improvised explosive devices (IEDs) have been the cause of these TBIs. For example, data from the Defense Manpower Data Center indicates that as of October 3, 2011, explosive devices have been responsible for an estimated two-thirds or more of the battlefield injuries in Iraq; of the 46,532 warriors wounded in Operations Enduring Freedom and Iraqi Freedom, 30,347 were wounded by explosive devices, many of which were IEDs. Most of these injuries involved concussive brain injury. While current estimates are that 15-19% of all returning Warfighters have a history of acute concussion or TBI during their tour(s) of duty. It has been noted that "22.8% of a Brigade Combat Team returned from Iraq with confirmed deployment-acquired traumatic brain injury."
Currently, there are no effective treatments for reversing or reducing the brain damage following TBI. Confounding the situation further, the symptoms of TBI can often overlap with those of post-traumatic stress disorder (PTSD) such as headache, dizziness, irritability, memory impairment, delayed problem solving, slowed reaction time, fatigue, visual disturbances, sleep disturbances, sensitivity to light and noise, impulsivity, judgment problems, emotional outbursts, depression, and anxiety. In addition, the rates of depression, anxiety, and other psychological symptoms are markedly elevated in TBI survivors, based on studies involving large samples of patients. As a result of this complexity and overlap of symptoms between TBI, PTSD, and depression, a clear diagnosis of TBI can be challenging, which can lead to misdirected treatment efforts and hamper the ability to accurately assess treatment response.
Multiple published research studies have validated the healing mechanisms of NIR, which can be delivered via light-emitting diodes (LED). NIR phototherapy has been used extensively for wound healing of soft tissue, for increasing circulation, for the treatment of pain and for specific conditions such as hair growth and carpal tunnel syndrome.
The mechanism of action that is central to the healing effect of NIR is increased blood circulation via the release of nitric oxide from red blood cells. Local increases in nitric oxide increase blood flow through arteries, veins and lymphatic ducts. Increased return of flow from treated sites helps to diminish intracellular acidosis that could alter mitochondrial membrane potential(s). This hypothesis holds that when blood flow is adequate, it provides a sufficient amount of oxygen and glucose to cells for adenosine triphosphate (ATP) generation by mitochondria. However, even a modest decrease in regional or global blood flow in the brain, such as that seen in TBI, will limit the amount of glucose and oxygen delivered to neurons. Restoring blood flow levels in damaged regions of the brain thus restores the necessary levels of glucose and oxygen required for ATP generation and proper neuronal functioning.
In addition, nitric oxide stimulates angiogenesis and increased numbers of capillaries will aid in increasing blood flow (and oxygen and glucose) in injured areas of the brain where blood flow was subnormal. This effect contributes to enhanced mitochondrial function. The 1998 Nobel Prize for physiology was awarded to Furchgott, Ignarroand, and Murad for their discovery that nitric oxide acts as a signaling molecule and activates an enzyme, guanylate cyclase (GC), which is necessary for subsequent vasodilation.
Finally, nitric oxide is an effective analgesic; it appears to reduce pain either by reversing local ischemia or directly in a manner akin to the analgesic effect of morphine. In the latter case, nitric oxide helps to regulate membrane potential via alterations in the activity of the ATP dependent potassium channel. This effect may be mediated by activated GC and subsequent phosphorylation of the potassium channel.
Due to its capacity to non-invasively penetrate the skull, NIR has been safely used since the late 1970s for the determination of cerebral blood flow and oxygen levels in brain injured adults, post-stroke patients, and in pediatric patients. Furthermore, transcranial NIR has been shown to increase cortical perfusion and is associated with clinical improvement in human subjects with traumatic brain injury, neurodegenerative disease, and depression. The NIR device for this study is FDA cleared (510K; K101894) for increasing circulation and reducing pain.
- Conditions
- TBI (Traumatic Brain Injury)
- Being tested
- Near-Infrared Phototherapy
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-Infrared PhototherapyDevice
Also called Polychromatic Light Therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Only one arm was used and this arm received Near-Infrared Phototherapy. Receives: Device: Near-Infrared Phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Neuropsychological testing focused on the cognitive abilities frequently affected by TBI. Includes subscales of the California Verbal Learning Test II.
Measured: T1: 2-14 days prior to pre-treatment SPECT brain scan; T2: 1-4 weeks post-treatment.
Change in Cognitive Functioning 3
Neuropsychological testing focused on the cognitive abilities frequently affected by TBI. Includes the Trail Making Test B.
Measured: T1: 2-14 days prior to pre-treatment SPECT brain scan; T2: 1-4 weeks post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startApr 2014
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for TBI (Traumatic Brain Injury)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerehealth Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tug McGraw Foundation, Colorado Neurological Institute
- Responsible party
- Sponsor
- Investigators
- Fred Grover, Jr., M.D., Principal investigator, RevolutionaryMD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635516
- Sponsor's protocol ID
- 2014.01.01
- Status last verified
- Dec 2015
- First submitted
- 15 Dec 2015
- Last updated
- 21 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified participant relevant demographic data will be reported. De-identified individual data analyses will be reported.
Publications
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.
PubMed 9596157Fann 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.
PubMed 14706944Hoge 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.
PubMed 20088060Jacobs 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.
PubMed 8862291Jorge 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.
PubMed 14706943Kashluba 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.
PubMed 18452740Kennedy 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.
PubMed 18075948Langlois 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.
PubMed 16983222Lew 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.
PubMed 16320135Nawashiro 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.
PubMed 22047598Schiffer 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.
PubMed 19995444Vaishnavi 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.
PubMed 19567758
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Mild and Moderate Traumatic Brain Injury in Veterans Using Near-Infrared Phototherapy
- ClinicalTrials.gov ID
- NCT02635516
- Acronym / sponsor ID
- 2014.01.01
- Conditions
- TBI (Traumatic Brain Injury)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Cerehealth Corp.Industry (pharma, biotech, devices)
- Collaborators
- Tug McGraw Foundation, Colorado Neurological Institute
- Study start
- Apr 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 21 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The incidence of traumatic brain injury is widespread. The Centers for Disease Control estimate that 1.7 million TBIs occur each year and that TBI is a contributing factor in about 30% of all injury-related deaths. In addition, about 75% of these TBIs are concussions, or mild TBIs (mTBI). However, such concussions, especially multiple concussions that occur over time, are not harmless. The damage of even mild TBI can potentially lead to neuropsychiatric sequelae. Moreover, injury to the brain can worsen over time depending on the degree of inflammatory response and the areas of injury. TBI induces a number of neuropathological changes like aggregation of beta amyloid and tau proteins along with neuroinflammatory changes that resemble the pathology of degenerative diseases.
For many of our returning Veterans, improvised explosive devices (IEDs) have been the cause of these TBIs. For example, data from the Defense Manpower Data Center indicates that as of October 3, 2011, explosive devices have been responsible for an estimated two-thirds or more of the battlefield injuries in Iraq; of the 46,532 warriors wounded in Operations Enduring Freedom and Iraqi Freedom, 30,347 were wounded by explosive devices, many of which were IEDs. Most of these injuries involved concussive brain injury. While current estimates are that 15-19% of all returning Warfighters have a history of acute concussion or TBI during their tour(s) of duty. It has been noted that "22.8% of a Brigade Combat Team returned from Iraq with confirmed deployment-acquired traumatic brain injury."
Currently, there are no effective treatments for reversing or reducing the brain damage following TBI. Confounding the situation further, the symptoms of TBI can often overlap with those of post-traumatic stress disorder (PTSD) such as headache, dizziness, irritability, memory impairment, delayed problem solving, slowed reaction time, fatigue, visual disturbances, sleep disturbances, sensitivity to light and noise, impulsivity, judgment problems, emotional outbursts, depression, and anxiety. In addition, the rates of depression, anxiety, and other psychological symptoms are markedly elevated in TBI survivors, based on studies involving large samples of patients. As a result of this complexity and overlap of symptoms between TBI, PTSD, and depression, a clear diagnosis of TBI can be challenging, which can lead to misdirected treatment efforts and hamper the ability to accurately assess treatment response.
Multiple published research studies have validated the healing mechanisms of NIR, which can be delivered via light-emitting diodes (LED). NIR phototherapy has been used extensively for wound healing of soft tissue, for increasing circulation, for the treatment of pain and for specific conditions such as hair growth and carpal tunnel syndrome.
The mechanism of action that is central to the healing effect of NIR is increased blood circulation via the release of nitric oxide from red blood cells. Local increases in nitric oxide increase blood flow through arteries, veins and lymphatic ducts. Increased return of flow from treated sites helps to diminish intracellular acidosis that could alter mitochondrial membrane potential(s). This hypothesis holds that when blood flow is adequate, it provides a sufficient amount of oxygen and glucose to cells for adenosine triphosphate (ATP) generation by mitochondria. However, even a modest decrease in regional or global blood flow in the brain, such as that seen in TBI, will limit the amount of glucose and oxygen delivered to neurons. Restoring blood flow levels in damaged regions of the brain thus restores the necessary levels of glucose and oxygen required for ATP generation and proper neuronal functioning.
In addition, nitric oxide stimulates angiogenesis and increased numbers of capillaries will aid in increasing blood flow (and oxygen and glucose) in injured areas of the brain where blood flow was subnormal. This effect contributes to enhanced mitochondrial function. The 1998 Nobel Prize for physiology was awarded to Furchgott, Ignarroand, and Murad for their discovery that nitric oxide acts as a signaling molecule and activates an enzyme, guanylate cyclase (GC), which is necessary for subsequent vasodilation.
Finally, nitric oxide is an effective analgesic; it appears to reduce pain either by reversing local ischemia or directly in a manner akin to the analgesic effect of morphine. In the latter case, nitric oxide helps to regulate membrane potential via alterations in the activity of the ATP dependent potassium channel. This effect may be mediated by activated GC and subsequent phosphorylation of the potassium channel.
Due to its capacity to non-invasively penetrate the skull, NIR has been safely used since the late 1970s for the determination of cerebral blood flow and oxygen levels in brain injured adults, post-stroke patients, and in pediatric patients. Furthermore, transcranial NIR has been shown to increase cortical perfusion and is associated with clinical improvement in human subjects with traumatic brain injury, neurodegenerative disease, and depression. The NIR device for this study is FDA cleared (510K; K101894) for increasing circulation and reducing pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Near-Infrared PhototherapyOnly one arm was used and this arm received Near-Infrared Phototherapy. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near-Infrared PhototherapyAlso: Polychromatic Light TherapyThe 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. | Device | Treatment |
Primary outcome
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.
2 secondary outcomes
Change in Cognitive Functioning 2
Time frame: T1: 2-14 days prior to pre-treatment SPECT brain scan; T2: 1-4 weeks post-treatment.
Change in Cognitive Functioning 3
Time frame: T1: 2-14 days prior to pre-treatment SPECT brain scan; T2: 1-4 weeks post-treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2015.
- Background: PubMed 9596157Abdel-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.
- Background: PubMed 14706944Fann 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.
- Background: PubMed 20088060Hoge 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.
- Background: PubMed 8862291Jacobs 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.
- Background: PubMed 14706943Jorge 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.
- Background: PubMed 18452740Kashluba 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.
- Background: PubMed 18075948Kennedy 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.
- Background: PubMed 16983222Langlois 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.
- Background: PubMed 16320135Lew 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.
- Background: PubMed 22047598Nawashiro 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.
- Background: PubMed 19995444Schiffer 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.
- Background: PubMed 19567758Vaishnavi 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.
- Individual participant dataSharing planned: Yes. De-identified participant relevant demographic data will be reported. De-identified individual data analyses will be reported.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fred Grover, Jr., M.D. principal investigator
RevolutionaryMD
Questions about this trial
What is this clinical trial studying?
A study testing Near-Infrared Phototherapy in people with TBI (Traumatic Brain Injury), run by Cerehealth Corp..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02635516, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2015.