Near-Infrared Laser Stimulation for Various Neurological Conditions
NCT ID: NCT04489082
Last Updated: 2022-09-28
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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UNKNOWN
NA
400 participants
INTERVENTIONAL
2021-01-02
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Near Infrared Laser Therapy
On the days of each near-infrared therapy session, patients will undergo 10 minutes of transcranial infrared laser stimulation.
The laser dose for all conditions will be a 3.4 W continuous laser wave, at a 1064 wavelength, with irradiance (power density) at 250 milli-Watts/cm2. All groups will have treatment once a week (10 minutes per session) for 5-6 weeks. For Alzheimer's, the site targeted will be the right prefrontal cortex. Parkinson's patients will have laser delivered to the brain stem, bilateral temporal lobes. TBI/CTE patients will have the laser stimulation site dependent on location of injury. Patients with depression/anxiety will have laser stimulation applied to the prefrontal area of the head.
Near Infrared Laser Stimulation
10 minutes of transcranial near infrared laser stimulation
Interventions
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Near Infrared Laser Stimulation
10 minutes of transcranial near infrared laser stimulation
Eligibility Criteria
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Inclusion Criteria
* Score greater than 13 on the Beck Depression Inventory
* Failure to remit with 3 antidepressants
* At least 18 years of age
* Diagnosis of Generalized or Acute Anxiety Disorder
* Score greater than 22 on the Beck Anxiety Inventory
* Failure to remit with 3 anxiolytics
* At least 18 years of age
* Cognitive decline with mild cognitive impairment (Clinical Dementia Rating stage 0.5) through moderate dementia (CDR stage 2)
* Lumbar puncture for Abeta 42 and Tau proteins evincing clinical correlation of neurodegenerative disease pathology
* Advanced MRI of the brain including volume measurement of the hippocampus, blood-oxygen level dependent imaging, and arterial spin labeling perfusion scans. On entry, patients will have CDR stage of at least 0.5 and at least one abnormal imaging biomarker.
* Diagnosis of Traumatic Brain Injury or Chronic Traumatic Encephalopathy
* At least 18 years of age
Exclusion Criteria
* Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)
* Advanced kidney, pulmonary, cardiac or liver failure
* Advanced terminal illness
* Any active cancer or chemotherapy
* Bone marrow disorder
* Myeloproliferative disorder
* Sickle cell disease
* Primary pulmonary hypertension
* Immunocompromising conditions and/or immunosuppressive therapies
* Any other neoplastic illness or illness characterized by neovascularity
* Subjects unable to give informed consent
* Subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep
* Recent surgery or dental work within 3 months of the scheduled procedure.
* Pregnancy, women who may become pregnant or are breastfeeding
18 Years
FEMALE
No
Sponsors
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Neurological Associates of West Los Angeles
OTHER
Responsible Party
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Principal Investigators
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Sheldon Jordan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Neurological Associates of West Los Angeles
Locations
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Neurological Associates of West Los Angele
Santa Monica, California, United States
Countries
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References
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Alosco ML, Stein TD, Tripodis Y, Chua AS, Kowall NW, Huber BR, Goldstein LE, Cantu RC, Katz DI, Palmisano JN, Martin B, Cherry JD, Mahar I, Killiany RJ, McClean MD, Au R, Alvarez V, Stern RA, Mez J, McKee AC. Association of White Matter Rarefaction, Arteriolosclerosis, and Tau With Dementia in Chronic Traumatic Encephalopathy. JAMA Neurol. 2019 Nov 1;76(11):1298-1308. doi: 10.1001/jamaneurol.2019.2244.
Asken BM, Sullan MJ, DeKosky ST, Jaffee MS, Bauer RM. Research Gaps and Controversies in Chronic Traumatic Encephalopathy: A Review. JAMA Neurol. 2017 Oct 1;74(10):1255-1262. doi: 10.1001/jamaneurol.2017.2396.
Bandelow B, Michaelis S. Epidemiology of anxiety disorders in the 21st century. Dialogues Clin Neurosci. 2015 Sep;17(3):327-35. doi: 10.31887/DCNS.2015.17.3/bbandelow.
Chauhan NB. Chronic neurodegenerative consequences of traumatic brain injury. Restor Neurol Neurosci. 2014;32(2):337-65. doi: 10.3233/RNN-130354.
Cipriani A, Furukawa TA, Salanti G, Geddes JR, Higgins JP, Churchill R, Watanabe N, Nakagawa A, Omori IM, McGuire H, Tansella M, Barbui C. Comparative efficacy and acceptability of 12 new-generation antidepressants: a multiple-treatments meta-analysis. Lancet. 2009 Feb 28;373(9665):746-58. doi: 10.1016/S0140-6736(09)60046-5.
Coupe P, Manjon JV, Lanuza E, Catheline G. Lifespan Changes of the Human Brain In Alzheimer's Disease. Sci Rep. 2019 Mar 8;9(1):3998. doi: 10.1038/s41598-019-39809-8.
Edwards G 3rd, Zhao J, Dash PK, Soto C, Moreno-Gonzalez I. Traumatic Brain Injury Induces Tau Aggregation and Spreading. J Neurotrauma. 2020 Jan 1;37(1):80-92. doi: 10.1089/neu.2018.6348. Epub 2019 Aug 28.
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Galgano M, Toshkezi G, Qiu X, Russell T, Chin L, Zhao LR. Traumatic Brain Injury: Current Treatment Strategies and Future Endeavors. Cell Transplant. 2017 Jul;26(7):1118-1130. doi: 10.1177/0963689717714102.
Hamblin MR. Shining light on the head: Photobiomodulation for brain disorders. BBA Clin. 2016 Oct 1;6:113-124. doi: 10.1016/j.bbacli.2016.09.002. eCollection 2016 Dec.
Montenigro PH, Corp DT, Stein TD, Cantu RC, Stern RA. Chronic traumatic encephalopathy: historical origins and current perspective. Annu Rev Clin Psychol. 2015;11:309-30. doi: 10.1146/annurev-clinpsy-032814-112814. Epub 2015 Jan 12.
Montgomery SA, Baldwin DS, Riley A. Antidepressant medications: a review of the evidence for drug-induced sexual dysfunction. J Affect Disord. 2002 May;69(1-3):119-40. doi: 10.1016/s0165-0327(01)00313-5.
Ni H, Yang S, Siaw-Debrah F, Hu J, Wu K, He Z, Yang J, Pan S, Lin X, Ye H, Xu Z, Wang F, Jin K, Zhuge Q, Huang L. Exosomes Derived From Bone Mesenchymal Stem Cells Ameliorate Early Inflammatory Responses Following Traumatic Brain Injury. Front Neurosci. 2019 Jan 24;13:14. doi: 10.3389/fnins.2019.00014. eCollection 2019.
Rojas JC, Gonzalez-Lima F. Neurological and psychological applications of transcranial lasers and LEDs. Biochem Pharmacol. 2013 Aug 15;86(4):447-57. doi: 10.1016/j.bcp.2013.06.012. Epub 2013 Jun 24.
Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, Niederehe G, Thase ME, Lavori PW, Lebowitz BD, McGrath PJ, Rosenbaum JF, Sackeim HA, Kupfer DJ, Luther J, Fava M. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov;163(11):1905-17. doi: 10.1176/ajp.2006.163.11.1905.
Schneider JA. Multiple Pathologic Pathways to Dementia in Football Players With Chronic Traumatic Encephalopathy. JAMA Neurol. 2019 Nov 1;76(11):1283-1284. doi: 10.1001/jamaneurol.2019.1089. No abstract available.
Takahata K, Kimura Y, Sahara N, Koga S, Shimada H, Ichise M, Saito F, Moriguchi S, Kitamura S, Kubota M, Umeda S, Niwa F, Mizushima J, Morimoto Y, Funayama M, Tabuchi H, Bieniek KF, Kawamura K, Zhang MR, Dickson DW, Mimura M, Kato M, Suhara T, Higuchi M. PET-detectable tau pathology correlates with long-term neuropsychiatric outcomes in patients with traumatic brain injury. Brain. 2019 Oct 1;142(10):3265-3279. doi: 10.1093/brain/awz238.
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Other Identifiers
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20192916
Identifier Type: -
Identifier Source: org_study_id
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