Effectiveness of Light for Enhancement of Cognition by Transcranial Repeated Application (ELECTRA)
NCT ID: NCT02817061
Last Updated: 2019-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2018-03-27
2019-09-01
Brief Summary
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Hypothesis: The investigators predict that tPBM will increase cognitive functioning, as measured by Cambridge Cognition cognitive testing in study subjects.
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Detailed Description
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Primary cellular effects include increases in mitochondrial activity and ATP levels, production of low levels of reactive oxygen species, induction of transcription factors (including the pro- survival NF-kB), and inhibition of apoptosis.
Over the past decade several studies have reported that a single, transcranial PBM treatment at 810 nm delivered to the head had significant, beneficial effect when used to treat acute ischemic stroke in several different animal models and also in human clinical trials. A similar approach was used to treat acute traumatic brain injury (TBI) in mice and in humans. Pathological examination of the mouse brains demonstrated up- regulation of brain-derived neurotrophic factor (BDNF) and stimulated neurogenesis in the hippocampus and increased synaptogenesis in the cortex.
A clinical trial is currently in progress at MGH to treat persons with acute moderate TBI. Several studies have shown improvement of cognitive function in persons with chronic TBI. Studies have also been conducted in animal models and in persons with Alzheimer's disease, Parkinson's disease, depression and anxiety.
Only a very limited number of studies have so far been carried out to test NIR photobiomodulation in normal experimental rodents and in normal human volunteers.
In this study, an LED array light source will be used that has been cleared by the FDA for other human uses.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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NIR brain stimulation
An Omnilux device will be used to put NIR light on the head and forehead of the subject age 18-25 or 65-85. The device is a low risk device as determined by the IRB. Thirty (30) subjects will receive this light at 6 visits over 16 weeks.
An automated interactive software self-test will be used at baseline and at three subsequent visits to quantify subject cognitive functions.
Omnilux
The Omnilux LED array sources can be changed to emit different wavelength.
Sham
An Omnilux Device will be used at a safe wavelength not associated with photobiomodulation, putting sham light on the head and forehead of the subject age 18-25 or 65-85. The device is a low risk device as determined by the IRB. Thirty (30) subjects will receive this light at 6 visits over 16 weeks.
An automated interactive software self-test will be used at baseline and at three subsequent visits to quantify subject cognitive functions.
Omnilux
The Omnilux LED array sources can be changed to emit different wavelength.
Interventions
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Omnilux
The Omnilux LED array sources can be changed to emit different wavelength.
Eligibility Criteria
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Inclusion Criteria
* Women of child-bearing potential, must use a double-barrier method for birth control (e.g. condoms with spermicide) if sexually active during the study and for 30 days post treatment of any kind.
* Subject Informed Consent obtained in writing in compliance with local regulations prior to enrollment into this study.
* The subject (and caregiver, if applicable) is willing to participate in this study for at least 12 weeks.
Exclusion Criteria
* Pregnancy or lactation
* History of stroke or traumatic brain injury
* Substance dependence or abuse in the past 6 months
* Diagnosis with major psychiatric disease (Psychotic disorder or psychotic episode, bipolar affective disorder)
* Diagnosed with a neurodevelopmental condition (autism or ADHD)
* A traumatic event that resulted in PTSD
* Any unstable medical illness (defined as any medical illness which has not been well-controlled with standard-of-care medications)
* A significant skin condition (i.e., hemangioma, scleroderma, rash, open wound) or medical implant (e.g. metal plate, implantable shunt or valve) on the head.
* Inability to understand or participate in the consent and performance of the study.
* Those with Parkinson's Disease, End Stage Renal Disease, and/or End Stage Liver Disease
18 Years
85 Years
ALL
Yes
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Richard Rox Anderson, MD
Director, Wellman Center for Photomedicine
Principal Investigators
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R. Rox Anderson, MD
Role: PRINCIPAL_INVESTIGATOR
MGH
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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Chung H, Dai T, Sharma SK, Huang YY, Carroll JD, Hamblin MR. The nuts and bolts of low-level laser (light) therapy. Ann Biomed Eng. 2012 Feb;40(2):516-33. doi: 10.1007/s10439-011-0454-7. Epub 2011 Nov 2.
Lapchak PA. Taking a light approach to treating acute ischemic stroke patients: transcranial near-infrared laser therapy translational science. Ann Med. 2010 Dec;42(8):576-86. doi: 10.3109/07853890.2010.532811. Epub 2010 Nov 1.
Huang YY, Gupta A, Vecchio D, de Arce VJ, Huang SF, Xuan W, Hamblin MR. Transcranial low level laser (light) therapy for traumatic brain injury. J Biophotonics. 2012 Nov;5(11-12):827-37. doi: 10.1002/jbio.201200077. Epub 2012 Jul 17.
Naeser MA, Hamblin MR. Traumatic Brain Injury: A Major Medical Problem That Could Be Treated Using Transcranial, Red/Near-Infrared LED Photobiomodulation. Photomed Laser Surg. 2015 Sep;33(9):443-6. doi: 10.1089/pho.2015.3986. Epub 2015 Aug 17. No abstract available.
Xuan W, Vatansever F, Huang L, Hamblin MR. Transcranial low-level laser therapy enhances learning, memory, and neuroprogenitor cells after traumatic brain injury in mice. J Biomed Opt. 2014;19(10):108003. doi: 10.1117/1.JBO.19.10.108003.
Xuan W, Agrawal T, Huang L, Gupta GK, Hamblin MR. Low-level laser therapy for traumatic brain injury in mice increases brain derived neurotrophic factor (BDNF) and synaptogenesis. J Biophotonics. 2015 Jun;8(6):502-11. doi: 10.1002/jbio.201400069. Epub 2014 Sep 8.
Farfara D, Tuby H, Trudler D, Doron-Mandel E, Maltz L, Vassar RJ, Frenkel D, Oron U. Low-level laser therapy ameliorates disease progression in a mouse model of Alzheimer's disease. J Mol Neurosci. 2015 Feb;55(2):430-6. doi: 10.1007/s12031-014-0354-z. Epub 2014 Jul 4.
Johnstone DM, Moro C, Stone J, Benabid AL, Mitrofanis J. Turning On Lights to Stop Neurodegeneration: The Potential of Near Infrared Light Therapy in Alzheimer's and Parkinson's Disease. Front Neurosci. 2016 Jan 11;9:500. doi: 10.3389/fnins.2015.00500. eCollection 2015.
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.
Michalikova S, Ennaceur A, van Rensburg R, Chazot PL. Emotional responses and memory performance of middle-aged CD1 mice in a 3D maze: effects of low infrared light. Neurobiol Learn Mem. 2008 May;89(4):480-8. doi: 10.1016/j.nlm.2007.07.014. Epub 2007 Sep 12.
Blanco NJ, Maddox WT, Gonzalez-Lima F. Improving executive function using transcranial infrared laser stimulation. J Neuropsychol. 2017 Mar;11(1):14-25. doi: 10.1111/jnp.12074. Epub 2015 May 28.
Other Identifiers
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2016P001134
Identifier Type: -
Identifier Source: org_study_id
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