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favela808 1883 posts  |  Last Activity: Apr 14, 2014 9:29 AM Member since: Jan 23, 2003
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  • Scrambler Therapy in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy
    This study is not yet open for participant recruitment.
    Verified April 2014 by Sidney Kimmel Comprehensive Cancer Center
    Sponsor:
    Sidney Kimmel Comprehensive Cancer Center
    Information provided by (Responsible Party):
    Sidney Kimmel Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT02111174
    First received: March 23, 2014
    Last updated: April 8, 2014
    Last verified: April 2014
    History of Changes
    Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
    Purpose
    The purpose of this study is to see if Scrambler Therapy with the Calmare MC5-A machine will relieve chemotherapy induced peripheral neuropathy (CIPN).

    Scrambler Therapy is a method of pain relief given with common electrocardiography (ECG) skin electrodes. The electrodes are placed on the body in pairs, and the Scrambler Therapy machine directs electrical signals across the field to simulate non-pain information.

    Based on other studies, we think that we relieve pain with the Scrambler therapy device, but it has not been tested in a setting such as this one. This means that some of the pain relief could be due to placebo effect, or the CIPN pain going away on its own. In this study we want to compare the Scrambler Therapy with the sham therapy (the therapy that does not use the electrical signals). We hope that this study will help us determine if the Scrambler device really helps patients with CIPN.

    Cancer patients with chronic, chemotherapy-related pain of 4 or more (on a 0-10 scale) for at least 3 months may be eligible to join this study.

    Sentiment: Strong Buy

  • Competitive Technologies (NASDAQ:CTTC)‘s stock had its “neutral” rating reiterated by Zacks in a research report issued to clients and investors on Wednesday, ARN reports. They currently have a $0.50 target price on the stock. Zacks‘s price target would indicate a potential upside of 61.29% from the company’s current price.
    Zacks’ analyst wrote, “Competitive Technologies’ current main focus lies with the marketing and distribution of the FDA-cleared and CE Marked Calmare pain therapy device. While several small studies provide some support of its efficacy, lack of broad reimbursement from private and public payers has been a significant headwind in accelerating commercialization of Calmare. A new CEO was brought onboard to orchestrate a turnaround which includes the plan to run two pivotal clinical studies to support an FDA PMA submission and improved reimbursement status. A near-term initiative to spark a resurgence in revenue growth includes streamlining the process to sell to U.S. government entities. While we think the new commercialization strategy makes sense, an investment in CTI is not without meaningful risk which is factored into our investment rating. We are initiating coverage of CTI with a Neutral rating and $0.50/share price target. “
    Competitive Technologies (NASDAQ:CTTC) traded up 10.67% during mid-day trading on Wednesday, hitting $0.31. 23,150 shares of the company’s stock traded hands. Competitive Technologies has a 52 week low of $0.05 and a 52 week high of $0.48. The stock’s 50-day moving average is $0.29 and its 200-day moving average is $0.25. The company’s market cap is $5.9 million.

    Sentiment: Strong Buy

  • Reply to

    Pain Article

    by favela808 Feb 25, 2014 10:37 AM
    favela808 favela808 Feb 25, 2014 10:43 AM Flag

    At first, these new nerve impulses going through my central nervous system felt a bit like a bee sting or a strange vibration. But after a minute or two, the only thing I noticed was the pain receding. Even though my pain came back after a few hours that first day, it reminded me what having a normal, pain-free life was like, something I wouldn’t have thought possible.

    For the first time in months, I was able to sit with my legs down in a chair — not balled up close to my body to keep them from swelling painfully. When I touched my typically oversensitive skin, it also felt different. I could feel the skin and the muscles in my legs again. It felt so weird. Good weird.

    When I left the clinic after that first day of treatment, everyone in the room got hugs. I had never hugged a doctor before.

    When I got home, I was able to take a nap for the first time in weeks. I actually fell asleep in a chair while reading because I felt so good.

    I was really skeptical when I first heard about Calmare because I know things like TENS and spinal cord stimulators don’t work for me. I was really apprehensive, but I am so glad that I tried it and that is working.

    The pain that I still experience daily is different from the pain I had a week ago. I am only halfway through my treatment and it is amazing! Compared to everything else I have tried, this is working wonders. I have pain-free times every day. Each day I walked into the clinic with less and less pain and walked out pain-free.

    I have actually been able to get out of the house! I went to the mall and walked around, took my dog on a long walk, and took my family to a water park. It has been a life changer!

    I’m super excited to see where the rest of the treatment takes me. I am hopeful that this treatment may allow my husband and I to finally start planning on having another baby, which was something we never thought possible because of my CRPS.

  • Reply to

    Pain Article

    by favela808 Feb 25, 2014 10:37 AM
    favela808 favela808 Feb 25, 2014 10:40 AM Flag

    ’ve only been walking since I attended the Rehabilitation Institute of Washington’s CRPS program in Seattle in November of last year, which got me out of a wheelchair and back on my feet. That was certainly a change for the better, but my quality of life was still nowhere near what I wanted it to be. A 4-5 on the 10 pain scale had become my “tolerable normal” and what I was beginning to anticipate for the rest of my life.

    image (2)The thing about Calmare that boggles my mind is that after trying all manner of painful procedures and medicines, and waiting weeks or months to see a result — if you have the type of pain that Calmare therapy treats, you’ll know if it will be successful for you within a few minutes.

    My first day of therapy, I walked in at a 6/10, and left an hour later, eerily close to pain-free. I started feeling a change in 30 minutes.

    The pain in my legs started to creep back in after a few hours, but I’m told that is typical after one treatment.

    Patients typically go for 10 consecutive days of Calmare treatment, though each case is different. By the end of that first round of treatment, the objective is that patients be pain-free for 30-90 days. At that point a booster treatment of one or two sessions will keep you going for another 30-90 days free of pain. It’s repeatable, not something your body is going to develop a resistance to the same way it might with drugs.

    The treatment itself is nothing more than being hooked by a few electrodes up to a machine. Electrodes placed, I might add, well outside of any area affected by pain.

    I like to think that Calmare works for pain much the same way that noise-canceling headphones do for ambient noise. The Calmare machine interrupts the chronic pain signals your brain is used to receiving and replaces those distorted nerve signals with a normal, pain-free sensation.

  • Reply to

    Pain Article

    by favela808 Feb 25, 2014 10:37 AM
    favela808 favela808 Feb 25, 2014 10:38 AM Flag

    Calmare uses electricity to block pain signals without the use of drugs. Originally developed for people suffering from chemotherapy induced peripheral neuropathy, Calmare has also been found to be and effective at treating other types of neuropathic pain, including Complex Regional Pain Syndrome (CRPS), which I’ve suffered from over the last two years.

    Calmare won’t treat mechanical pain, however. Mechanical pain in my case being the collapsed arch in my foot and the sprained ankle that led to my CRPS in the first place.

    Having the pain from my CRPS gone is like listening to the sounds of the forest, after being in an office building next to jackhammers and construction all day. The volume is turned down and suddenly you’re receiving far less sensory input. You are able to notice much more subtle nuanced things that you never had the capacity, energy or space to notice before.

    I can feel sore muscles in my foot again. I can feel them because my feet hurt so much and were so hypersensitive to touch and pressure that I wasn’t able to walk normally on them for nearly two years. My leg and foot muscles atrophied so much I had to retrain myself to walk with proper form.

  • favela808 by favela808 Feb 25, 2014 10:37 AM Flag

    National Pain Report

    Life in Pain: How Calmare Therapy Helped Me

    February 24th, 2014 by Amanda Siebe, Columnist
    Living with pain every day is kind of like living next to an airport. After a while you don’t hear the jets flying overhead anymore. They’re still there, in the middle of the night and the middle of the day, unending and ceaseless, but you don’t notice every time one flies over.

    Chronic pain is much the same. After you’ve had it long enough, your body accepts that sensation as normal. You no longer expect pleasant sensations from touch. You don’t expect to be able to wear normal clothes or take a shower. You don’t expect to be able to exercise muscles in that part of your body without excruciating pain.

    Occasionally, however, something happens that makes you reconsider everything that you’ve come to expect. Something happens that gives you a new normal.

    I started Calmare therapy last week at Pain Relief of Oregon in West Linn, OR.

    Most of my pain has gone away.

  • Reply to

    Medicare News

    by favela808 Jan 15, 2014 10:52 AM
    favela808 favela808 Feb 2, 2014 12:56 AM Flag

    inShare
    January 31, 2014 by Chris Walker

    Competitive Technologies wins a favorable Medicare coverage decision for its Calmare device, with labeling as a "medical necessity."

    Competitive Technologies lands Medicare coverage for pain management device
    Competitive Technologies said it secured a favorable decision concerning Medicare coverage for its Calmare pain management device.

    The Fairfield, Conn.-based medical device company develops products for wound and pain management. The Calmare is the company's flagship product, and is used to treat neurological pain.

    The Medicare decision allows for the device to be covered as a "medical necessity" in cancer-related chemotherapy treatment. The reimbursements will go to the Calmare Pain Relief Solutions, which developed the technology.

  • favela808 by favela808 Jan 15, 2014 10:52 AM Flag

    Competitive Tech's Calmare® Pain Device Therapy Garners Favorable Medicare Coverage Judgment
    Ruling Appeal Establishes Calmare Treatments a "Medical Necessity" In Cancer-Related Chemotherapy Pain Case
    PR Newswire Competitive Technologies, Inc.
    11 minutes ago
    FAIRFIELD, Conn., Jan. 15, 2014 /PRNewswire/ -- Competitive Technologies, Inc., (CTTC) (CTI), a biotechnology company, received a favorable Medicare treatment coverage judgment for its flagship medical technology device, the Calmare® pain therapy medical device, stemming from an appeal filed by an authorized Calmare practitioner in Staten Island, the Physical Medicine and Rehabilitation Associates of Staten Island, LLP (collectively, the Calmare Pain Relief Solutions or CPRS), by and through, Christopher M. Perez, M.D. U.S. Administrative Law Judge LeAnn R. Canter allowed the appeal, which resolved claims for Medicare coverage for a named Medicare enrollee (Beneficiary). The appeal allows CPRS to receive reimbursements for treatments using the Calmare Therapy for claims made in behalf of beneficiary.

    In the early part of 2011, CPRS was denied Medicare payments for treatments rendered to a Beneficiary who was 69 years old, at the time of the treatment. The Beneficiary had a medical history of breast cancer, for which she had undergone mastectomy and chemotherapy treatments. She had pain from the cancer-related chemotherapy treatments that had an intensity level of 7 on a scale of 10, and a pain recurrence of 75% of the time.

    The Calmare treatment was denied reimbursement coverage mostly due to the lack of inclusion of a Current Procedural Terminology (CPT) treatment code descriptor that would apply to the treatment type inherent to Calmare pain treatment therapy. CPRS filed an appeal (ALJ Appeal No 1-1009277156) to the Department of Human Services Office of Medicare Hearings and Appeals Midwestern Field Office in Cleveland, OH.

    Judge Canter's ruling established that there was reliable evidence and sufficient d

    Sentiment: Strong Buy

  • Doctors from The Best Health Institutions in the Country are referring their pain patients to Calmare

    Dr. D'Amato has personally trained physicians from the MAYO Clinic in Minnesota, Walter Reed Army Hospital, University of Miami and MDs affiliated with Harvard Medical School. Patients have been referred to Dr. D'Amato by doctors from prestigious Medical Institutions, including: Johns Hopkins, the MAYO Clinic and the Cleveland Clinic.

    They must be getting good results!

    Sentiment: Strong Buy

  • favela808 by favela808 Nov 29, 2013 9:48 AM Flag

    LD Micro Conference

    After eleven years of researching companies, writing reports, and putting our own capital on the line, LD MICRO is pleased to announce its sixth annual conference on December 3rd, 4th and 5th, 2013.

    The "Main Event" has become the Iron-Man of micro-cap.

    We've invited 233 companies in the small and micro cap space. Last year, over 1,000 people registered for the event.

    The conference will be held at the beautiful Luxe Sunset Bel Air, rated one of the premier hotels of Southern California.

    Thursday, December 5, 2013, at 11:30 AM PST / 2:30 PM EST.

    The three-day event will host 235 companies in the micro-cap space at the Luxe Sunset Bel Air in Los Angeles, California.

    CTI President & CEO Conrad Mir will present to investors the CTI's 2013 - 2014 corporate business plan. He

    will be available for one-on-one meetings during the conference.

    Sentiment: Strong Buy

  • STATEN ISLAND, NY--(Marketwired - Nov 5, 2013) - Calmare Pain Relief Solutions (the "Company"), a chronic pain treatment medical practice, will increase its Calmare Pain Therapy clinic network by 70% in the Tri-state area in 2014. This expansion is in response to the U.S. Food and Drug Administration's (FDA) position regarding the benefits of using a non-narcotic solution for the relief of chronic pain. This position was highlighted in a recent New York Times article entitled "FDA Shift on Painkillers was Years in the Making."
    With the increased acceptance of Calmare Pain Therapy by nationwide insurance companies, there has been an increase in new, chronic pain patient visitors to the Calmare Pain Relief Solutions' network of clinics. Their search for a non-invasive and non-narcotic pain relief regimen has resulted in the Company's redesigned corporate website. The site now offers chronic pain sufferers a web portal that houses a repository of information on the Calmare technology (commonly known as "Scrambler" technology). Visitors can view media reports and videos on the potential benefits gained from this alternative therapy versus a traditional biochemical solution. They can also read articles and research documents that may assist patients and healthcare providers in assessing the benefits of this technology.
    "We wanted to offer patients and insurance companies a very informative website on the Calmare pain relief therapy," said David J. Palmieri, healthcare consultant to Calmare Pain Relief Solutions. "We often get requests for well-referenced information from patients and insurance providers and our new website is a direct response to those requests."

    Sentiment: Strong Buy

  • It has been very hard to prevent and treat CIPN because a
    variety of drugs and supplements including glutamine, vitamin
    E, and glutathione have been disappointing. A recent study
    of a topical combination of the drugs baclofen, amitriptyline,
    and ketamine (which some doctors actually recommend) for
    treating CIPN showed some benefi t for sensory and motor
    neuropathy. Another study showed some promise for a
    patient-specifi c electro stimulation device (MC5-A Calmare;
    Competitive Technologies, Wakefi eld, RI). Th is Calmare®
    medical device is being further tested
    currently. Th is device sends a no-pain message to the nerve
    from surface electrodes applied to the skin in the area of the
    patient’s pain. Next, the perception of pain is apparently
    cancelled when the no-pain message replaces that of pain, by
    utilizing the same pathway through the surface electrodes. If it
    sounds a little confusing well it is but think of it like a message
    distorting device. Th e average treatment time is from 20-
    60 minutes. It sounds interesting and I really hope it works
    because CIPN needs help now!

    Sentiment: Strong Buy

  • Reply to

    Mayo Clinic Upates Calmare Study

    by favela808 Sep 13, 2013 9:28 AM
    favela808 favela808 Sep 24, 2013 3:02 AM Flag

    Why not tell the truth. It says in the update final data expected to be gathered by March 2014. Everyone cares what The Mayo clinic has to say.

    Sentiment: Strong Buy

  • Reply to

    Mayo Clinic Upates Calmare Study

    by favela808 Sep 13, 2013 9:28 AM
    favela808 favela808 Sep 13, 2013 9:30 AM Flag

    MedlinePlus related topics: Peripheral Nerve Disorders
    U.S. FDA Resources

    Further study details as provided by Mayo Clinic:

    Primary Outcome Measures:
    Change in pain on a 0-10 numerical rating scale. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

    Secondary Outcome Measures:
    Changes in neurologic function will be done by Neurometer Current Perception Threshold (CPT) testing and with a Rydel-Seiffer graduated tuning fork. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Patients will also undergo neurologic function testing. This will be done in an exploratory measure to try to correlate changes in the patient reported outcome instrument data with changes in the different measures of neurologic function. The two measures will be Neurometer Current Perception Threshold (CPT) Testing and testing with a Rydel-Seiffer graduated tuning fork.

    Estimated Enrollment: 150
    Study Start Date: March 2011
    Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

  • Reply to

    Mayo Clinic Upates Calmare Study

    by favela808 Sep 13, 2013 9:28 AM
    favela808 favela808 Sep 13, 2013 9:29 AM Flag

    Purpose
    This pilot clinical trial studies scrambler therapy in treating pain and peripheral neuropathy in patients previously treated with chemotherapy. Scrambler therapy may help relieve pain from peripheral neuropathy caused by chemotherapy

    Condition Intervention
    Pain
    Peripheral Neuropathy
    Other: scrambler therapy
    Other: questionnaire administration
    Procedure: management of therapy complications

    Study Type: Interventional
    Study Design: Endpoint Classification: Safety/Efficacy Study
    Intervention Model: Single Group Assignment
    Masking: Open Label
    Primary Purpose: Supportive Care
    Official Title: Scrambler Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy: An Open Access Trial

  • Scrambler Therapy in Treating Pain and Peripheral Neuropathy in Patients Previously Treated With Chemotherapy
    This study is currently recruiting participants.
    Verified September 2013 by Mayo Clinic
    Sponsor:
    Mayo Clinic
    Information provided by:
    Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT01347723
    First received: March 30, 2011
    Last updated: September 5, 2013
    Last verified: September 2013
    History of Changes

  • favela808 favela808 Sep 12, 2013 8:29 PM Flag

    Once the safety labeling changes are finalized, modifications will also be made to the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS), to reflect the updated information. Originally approved in 2012, the ER/LA Opioid Analgesics REMS requires companies to make available to health care professionals educational programs on how to safely prescribe ER/LA opioid analgesics and to provide Medication Guides and patient counseling documents containing information on the safe use, storage, and disposal of ER/ LA opioids.

    In addition to the safety labeling changes and postmarket study requirements, the FDA has issued responses to two related citizen petitions.

    “The FDA remains committed to improving the safety of opioids and to continuing to engage in efforts to evaluate and mitigate the risks associated with opioid use,” said Dr. Throckmorton. “Today’s safety labeling changes reflect the FDA’s current understanding of the risks and benefits of these products. The FDA will evaluate the results of the postmarket studies, continue to monitor relevant safety data, and take further safety action, as warranted.”

  • favela808 favela808 Sep 12, 2013 8:29 PM Flag

    “The FDA’s primary tool for informing prescribers about the approved uses of medications is the product labeling,” said Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “These labeling changes describe more clearly the risks and safety concerns associated with ER/LA opioids and will encourage better, more appropriate, prescribing, monitoring and patient counseling practices involving these drugs.”

    Recognizing that more information is needed to assess the serious risks associated with long-term use of ER/LA opioids, the FDA is requiring the drug companies that make these products to conduct further studies and clinical trials. The goals of these postmarket requirements are to further assess the known serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose, and death.

    The FDA is also requiring a new boxed warning on ER/LA opioid analgesics to caution that chronic maternal use of these products during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening and require management according to protocols developed by neonatology experts. NOWS can occur in a newborn exposed to opioid drugs while in the mother’s womb. Symptoms may include poor feeding, rapid breathing, trembling, and excessive or high-pitched crying.

    In addition, the FDA is notifying ER/LA opioid analgesic application holders of the need for changes to the following sections of drug labeling: Dosage and Administration; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information, and the Medication Guide.

  • FDA announces safety labeling changes and postmarket study requirements for extended-release and long-acting opioid analgesics
    New boxed warning to include neonatal opioid withdrawal syndrome

    The U.S. Food and Drug Administration today announced class-wide safety labeling changes and new postmarket study requirements for all extended-release and long-acting (ER/LA) opioid analgesics intended to treat pain.

    “The FDA is invoking its authority to require safety labeling changes and postmarket studies to combat the crisis of misuse, abuse, addiction, overdose, and death from these potent drugs that have harmed too many patients and devastated too many families and communities,” said FDA Commissioner Margaret A. Hamburg, M.D. “Today’s action demonstrates the FDA’s resolve to reduce the serious risks of long-acting and extended release opioids while still seeking to preserve appropriate access for those patients who rely on these medications to manage their pain.”

    Given the serious risks of using ER/LA opioids, the class-wide labeling changes, when final, will include important new language to help health care professionals tailor their prescribing decisions based on a patient’s individual needs.

    The updated indication states that ER/LA opioids are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

    The updated indication further clarifies that, because of the risks of addiction, abuse, and misuse, even at recommended doses, and because of the greater risks of overdose and death, these drugs should be reserved for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain; ER/LA opioid analgesics are not indicated for as-needed pain relief.

    Sentiment: Strong Buy

  • favela808 favela808 Sep 5, 2013 12:14 PM Flag

    Dr. Smith said that his success ratio is 80%. Consequently not all patients will have success. Some doctors go out of business once in a while. The point is a a very experienced Johns Hopkins doctor and researcher has used the device for four years now and says it works 80% of the time. and when you look at the alternative, Addicting drugs or a spinal chord stimulator there is NO comparison. Calmare is the clear choice of treatment.

    Sentiment: Strong Buy

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