Showing posts with label clinical study. Show all posts
Showing posts with label clinical study. Show all posts

Wednesday, February 27, 2013

Low Level Laser in the Treatment of Migraine and Traumatic Brain Injury in the Adult population


Pratibha Bansal M.D.,   Romanth Waghmarae M.D. DABA, FIPP. , Louis Banas B.S. , M.S. CLT ; Buffalo, New York,  June 2012

Note: Dr’s Bansal and Waghmarae are Board Certified Pain Management Physicians who have practicing Pain Management in Buffalo, New York for over 20 years.   Louis Banas is a laser specialist who has treated over 2500 hundred patients for chronic pain issues. He has treated over 60 adults for headaches of various types with significant success in most cases.   


Abstract:

Migraine headache due to trauma or otherwise is a major health concern worldwide with massive financial and social impact. Conventional treatments primarily focus on the prevention of further damage to the brain parenchyma, while failing to address the already existent symptoms. Previous clinical studies have shown that Low Level Laser Therapy (LLLT) can significantly reduce pain and induce temporary vasodilation in capillaries.  The authors demonstrate how LLLT can be used to improve the quality of life in patients by treating their current symptoms,. This case report illustrates the use of LLLT in the treatment of several patients with a severe headache and the clinical success achieved in the reduction of pain, as measured by VAS - achievable within 2-8 treatments.
Abstract:




Objective Information and Background.

The following case studies were followed at a Pain Management Clinic in Buffalo New York.  Pain Rehab is staffed with two board certified Pain Management Specialists who will see 300 to 400 patients weekly. Most patients were being seen do to traumatic injuries suffered at work, home or auto accident and in most cases had little or no relief with physical therapy, chiropractic, massage or surgery. Pain Rehab is very progressive in utilizing new and proven technology and reluctantly prescribes opiates and NSAIDS . All patients suffered from moderate to severe, debilitating pain on a daily basis. After a very positive evaluation of laser therapy on patients, a physical therapy clinic was added to the practice, therefore enabling this new modality to be readily available to their patients. Several patients suffering from chronic, debilitating headaches due to trauma or congenital defects were treated during a four month period. (It is important to note that headaches were just part of the overall pain complaints except for two patients noted in cases 4 and 7.) Over twenty patients were treated and only two patients out of twenty did not respond well. The treatments were performed by a laser specialist with four years of laser experience.  Listed below are a few of the significant, more interesting cases.

Case # 1.  A 28 y.o. female suffered severe whiplash in an auto injury and complained of daily, severe headaches with a vas value of 7-8 accompanied by blurred vision for a 12 month period. Laser was applied to bilateral temples and mastoid   for 2 minutes, delivering 15 joules to five sites, which included bilateral temple and mastoid sites and right cervical spine.  Patient was not able tolerate minimal cervical spine treatment. , including 6 joules per site for a 3 minute duration.  Note: Patient is African American and due to nerve damage or skin pigmentation could not tolerate prescribed dosage.   Treatment was given 3 times per week for two weeks at a reduced dosage for a total of six treatments.  Pain levels were substantially reduced and patient now only suffers 2-3 episodes per week with a vas value of 2-3.

Case #2 .  38 y.o. female, auto injury.  Previous physical therapy was unsuccessful. Patient complained of daily headaches 7-8 on the vas scale for two years.  Treatment included bilateral c-spine and right trapezium for 3 minutes time delivering 42.5 joules to each site, for a period of two weeks and levels increase to 72 joules for second week as patient healed and was more able to tolerate the procedure.  Patient received 12 treatments over a three week period and now experiences mild to moderate headaches once or twice per month.

Case 3#.  58 y.o. male was injured on the job and suffered a severe neck and left clavicle injury. Headaches were daily which were debilitating and patient reported a 7-8 level on the vas scale. Treatments of 8 sessions included 76.5 joules applied to left cervical spine and clavicle. 15 joules were applied to left cervical 1 area, after 10 treatments the headaches were entirely eliminated.

Case # 4. A 23 y.o. Female suffered from headaches 3-4 times per week since six years of age.  Patient has a high stress job as customer service representative. One treatment was applied at both temples delivering 15 joules in a two minute session. Patient was headache free for one week. 

Case#5.  A  57 y.o. female, auto injury 17 years ago and had damage to both frontal lobes. 28 Joules was applied to her forehead at two sites. Due to transportation difficulties her treatments are sporadic but after two treatments she now wakes up with minimal or no pain on most mornings.

Case #6.  A 52 y.o. male fell at work and hit back of head. Headaches occur on daily basis since accident 4 months ago.  Two treatments were performed two days apart delivering 25 joules to injured area. Patient states that headaches are significantly reduced and sleep patterns are substantially improved.

Case # 7. A 31 y.o. female former military P.A. presented herself with migraine headaches with a vas value of 7-8 on a daily basis. She has suffered with them since the age of 8.  The patient had seen several specialists including neurologists who were unable to help. The patient had military training as a physician’s assistant and realized she needed detoxing from drug overload which had been prescribed for the problem.   A single laser treatment was administered which included  48 joules at 2 sites on the forehead and 28 joules to four sites which included bilateral temple and mastoid areas.  The patient had significant relief for a 7 day period at which point she felt the change in medications was to blame. She returned for a single visit one day after the relapse and the  procedure was repeated.  The patient reported to be pain free within minutes after the procedure.  She feels she is completely healed.


Technical data:

The system utilized is the Theralase super pulsed Low Level Laser medical system. It  The system is equipped with a multiple probe hand piece (5 x 905 nm wavelength @0-100 mw average power per laser diode and 4 x 660 nm wavelength @25 mw . power per laser diode. (This allows for deep penetration of tissue when necessary with minimal heat transference to the tissue).

Healing pathways- Discussion

The majority of patients seen in this clinic have multiple injuries and headaches are a by-product of some type of trauma. Therefore, it may be safe to assume that vascular insufficiency is the main cause. A recently published a peer review paper concludes that the equipment used utilizes a 905 nm. Wavelength increasing Nitric acid up to 700 percent which expands capillary delivery of oxygenated blood. Currently Dr. Michael Whalen, working at Massachusetts General Hospital, is conducting controlled studies using a low level laser with the hopes of bringing this new technology into the forefront of neuroscience and medicine. These case studies give examples of how LLLT can be used to treat chronic migraines, specifically those that are a result of traumatic brain injuries. LLLT has been shown to reduce pain and inflammation, create a state of vasodilation by activating the nitric oxide pathway and further even promote angiogenesis.

ATP production.  Cold laser has the unique ability to generate the production of ATP Adenosine Tri-phosphate through a process called biostimualtion. Vacuoles (cytochromes and chromaphores) in the mitochondria of the cell absorb specific light wavelengths causing a cascade effect which rejuvenates damaged cells lacking this essential fuel molecule. Although this may be the main pathway for treating the traumatic injures, it is arguable that the nitric oxide production is the primary source of pain reduction.

Summary. LLLT is now becoming a valuable but slowly recognized modality for acute and chronic pain as well as wound care in the United States. It has been used extensively in Canada for over 12 years.



REFERENCES
1.            Faul M, X.L., Wald MM, Coronado VG, Traumatic brain injury in the United States: emergency department visits, hospitalizations, and deaths. 2010.
2.            Finkelstein E, C.P., Miller T and associates, The Incidence and Economic Burden of Injuries in the United States. Oxford University Press, 2006.
3.            Sahni, T., et al., Use of hyperbaric oxygen in traumatic brain injury: retrospective analysis of data of 20 patients treated at a tertiary care centre. Br J Neurosurg, 2012. 26(2): p. 202-7.
4.            Naeser, M.A. and M.R. Hamblin, Potential for transcranial laser or LED therapy to treat stroke, traumatic brain injury, and neurodegenerative disease. Photomed Laser Surg, 2011. 29(7): p. 443-6.
5.            Moriyama, Y., et al., In vivo effects of low level laser therapy on inducible nitric oxide synthase. Lasers Surg Med, 2009. 41(3): p. 227-31.
6.            Wu, Q., et al., Low-level laser therapy for closed-head traumatic brain injury in mice: effect of different wavelengths. Lasers Surg Med, 2012. 44(3): p. 218-26.

7.             Stephan, W. et al . Efficacy of super –pulsed 905 nm Low Level Laser Therapy in the Management of
Traumatic Brain Injury (TBI) World Journal of Neuroscience November 2012  www.scirp.org/journal/wjnsl



For further information, please visit www.theralase.com or call 1-855-494-7246

Tuesday, January 29, 2013

Renowned Oncologist Dr. Michael Jewett Joins Theralase’s Medical and Scientific Advisory Board


Toronto, Ontario –January 29, 2013 -- Theralase Technologies Inc. (TSX-V: TLT) is pleased to announce that effective January 15, 2013, Michael Jewett MD, FRCSC, FACS has elected to join its Medical and Scientific Advisory Board.

Dr. Michael Jewett is currently a Professor of Surgery in the Division of Urology at the University of Toronto, a member of the Department of Surgical Oncology at Princess Margaret Cancer Centre and of the Division of Urology at the University Health Network. He is well known for his contributions in the fields of technology assessment and image guided therapy, especially for minimally invasive treatment of kidney and bladder cancer. He is internationally known for his contributions in the fields of bladder, testis and kidney cancer fundamental and clinical research. For his valued contributions to the uro-oncology field, in 2008, Dr. Jewett was awarded the Wyeth/CIHR Rx&D Clinical Research Chair in Oncology. He also holds the Farquaharson Chair for Kidney Cancer Research.

Dr. Jewett has been the Principal Investigator/Co-Principal Investigator on over 60 Phase I-Phase III clinical trials and the Lead Principal Investigator of several Cooperative Group Trials. These clinical trials have primarily been focused on proving the safety, efficacy and clinical benefits of technology in the destruction of cancer, with the ultimate gain of achieving Health Canada or FDA clinical approval. 

He has recently served as Chairman of the Division of Urology at the University of Toronto and of Urology at the University Health Network, which incorporates the Princess Margaret Cancer Centre, one of the world's leading cancer centres. He is a recent Past-President of the Canadian Urology Association and a member of many urological and surgical oncology societies; including the Scientific Advisory Board of the Bladder Cancer Advocacy Network, the Medical Advisory and Research Board of Bladder Cancer Canada, and Chair of the CIHR funded Kidney Cancer Research Network of Canada. Dr. Jewett has been recognized for his lifetime achievements and contributions to Urology by the Canadian Urological Association, the American Urological Association, the Societe Internationale d’Urologie and the Society of Urologic Oncology.

Dr. Jewett stated, “I have been very impressed with the expertise of the Theralase team and with the significant opportunity their Photo Dynamic Compounds (PDCs) present in the field of bladder cancer treatment. I look forward to working with them closely in their quest to commercialize their PDC technology to the ultimate benefit of bladder cancer patients, when the unmet need remains so great”.

Roger Dumoulin-White, President and CEO, Theralase Technologies Inc. stated that, “We are elated to have someone of Dr. Jewett’s calibre join Theralase’s Medical and Scientific Advisory Board to lead our bladder cancer clinical research program. He has been actively engaged in clinical cancer research and will prove to be an invaluable resource for helping to design our clinical protocols, in conjunction with our research team, as we focus on our lead target, bladder cancer. With Dr. Jewett’s expert guidance, we are confident that we will be able to complete the steps necessary to commence FDA Phase 1 human clinical trials in 2013 with our lead Photo Dynamic Compound (PDC), where we will demonstrate that Theralase possesses a highly effective and safe alternative treatment option to patients, suffering from non-muscle invasive bladder cancer. Based on the clinical success of the PDC technology in FDA Phase 1 human clinical trials, Theralase is expected to be granted FDA “Fast Track” designation allowing an expedited priority review and approval process.”

According to the FDA, “Fast Track” is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.

About Theralase Technologies Inc.:
Theralase Technologies Inc., founded in 1995, designs, develops, manufactures and markets patented, superpulsed laser technology utilized in biostimulation and biodestruction applications. Theralase technology is safe and effective in treating pain, inflammation and for tissue regeneration of neural muscular skeletal conditions and wound healing. Theralase is currently developing patented Photo Dynamic Compounds (PDCs) that are able to target and destroy cancers, bacteria and viruses when light activated by Theralase’s proprietary and patented laser technology.

 For further information please visit www.theralase.com , regulatory filings may be viewed by visiting www.sedar.com.
 
This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual results could differ materially from those projected herein. The Company disclaims any obligation to update these forward-looking statements.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchanges) accepts responsibility for the adequacy or accuracy of this release.

For More Information:
Roger Dumoulin-White                                                                     
President & CEO                    
416-694-7246 ext. 225                                  
rwhite@theralase.com

Kristina Hachey
Chief Financial Officer
416-694-7246 ext. 224
khachey@theralase.com 

Arkady Mandel
Chief Scientific Officer
416-694-7246 ext. 242
amandel@theralase.com

Greg Bewsh
Director of Investor Relations
416-694-7246 ext. 262
gbewsh@theralase.com   

Friday, October 12, 2012

Theralase Effective in the Treatment of Tobacco Addiction


Toronto, Ontario – October 12, 2012 -- Theralase Technologies Inc. (TSX-V: TLT) announced today that the Theralase therapeutic laser system, has been proven clinically effective in the treatment of tobacco addiction. 
 
The Theralase technology was clinically evaluated on over 500 subjects, who were heavy smokers, to validate if they were able to reduce their smoking by at least 25%, 30 days after receiving the Theralase laser treatment. The results of the clinical study demonstrated that 405 (73.8%) subjects had reduced their consumption of tobacco products by 25% or more, with 373 (92.0%) completely eliminating use and 32 of those subjects (8.0%) showing a reduction of at least 25%. 
 
Smoking is one of the most preventable illnesses that plague the American population. In 2009, the Centers for Disease Control and Prevention estimated that smoking accounted for $96 billion a year in direct health care costs and an additional $97 billion a year in lost productivity. Smoking addiction is a complex condition, which can disrupt a person’s life, leading to severe health concerns, deterioration of major organs, incurable diseases and eventually pre-mature death. In fact, more deaths are caused each year by tobacco use than by all deaths from human immunodeficiency virus (HIV), illegal drug use, alcohol use, motor vehicle injuries, suicides and murders combined, with cigarette smoking causing 1 out of every 5 deaths in the United States each year.
 
Roger Dumoulin-White, President and CEO of Theralase stated that Due to the complexity of smoking addiction and the poor success rate that alternative cessation methods have had, this independent clinical study was commissioned to enroll 549 subjects, from a homogeneous, cosmopolitan population of heavy smokers. The treatment group consisted of a relatively equal representation of male and female subjects with an average age in the mid to late forties. A Theralase therapeutic laser system was applied to specific ear and body acupuncture points to determine if the subject could reduce their smoking consumption by 25% or more 30 days after treatment. The results of the clinical study demonstrated that at the 30 day follow-up end point, 405 (73.8%) subjects had met the outcome criteria and had reduced their consumption of tobacco products by 25% or more, with 373 of those subjects (92.0%) completely eliminating use of tobacco products and 32 of those subjects (8.0%) showing a reduction of at least 25%. This non-pharmacologic and non-invasive therapeutic modality exceeds the effectiveness of other therapeutic options currently available for smoking cessation treatment, including nicotine patch, nicotine gum and other pharmaceutical alternatives.”

Dr. Arkady Mandel, Chief Scientific Officer of Theralase said, “Due to the significant reduction in the consumption of tobacco products by 405 (73.8%) subjects by 25% or more at the 30 day follow-up end point, the Theralase laser technology may find itself as a first line approach to combatting long term tobacco addiction in the not too distant future. Theralase laser acupuncture treatments may represent a safe and effective alternative for reducing the amount of tobacco products consumed by smokers”.

About Theralase Technologies Inc.:
Theralase Technologies Inc., founded in 1995, designs, develops, manufactures and markets patented, superpulsed laser technology utilized in biostimulation and biodestruction applications. Theralase technology is safe and effective in treating pain, inflammation and for tissue regeneration of neural muscular skeletal conditions and wound healing in both humans and animals. Theralase complies with all FDA, Health Canada, CE and international regulatory approvals to produce clinically effective, safe and high quality products. Theralase also develops patented Photo Dynamic Compound (PDC) technology focused at targeting and destroying cancers, bacteria and viruses when light activated by Theralase’s proprietary and patented laser technologies.

For further information please visit www.theralase.com, regulatory filings may be viewed by visiting www.sedar.com.

This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual results could differ materially from those projected herein. The Company disclaims any obligation to update these forward-looking statements.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchanges) accepts responsibility for the adequacy or accuracy of this release.

For More Information, please contact:

Roger Dumoulin - White,                                                                                
President and CEO                                                                                            
416-447-8455 ext. 225                                                                                     

Kristina Hachey
Chief Financial Officer
416-447-8455 ext. 224
khachey@theralase.com                                                                                

Greg Bewsh
Director of Investor Relations
416-447-8455 ext. 262

Arkady Mandel
Chief Scientific Officer
416-447-8455 ext. 242
amandel@theralase.comlase.com