Friday, April 19, 2024

What Is The Depression Treatment Device

What Is Vagus Nerve Stimulation

Depression Treatment Device

Vagus nerve stimulation uses a repetitive, mild electrical current to activate/depolarize the vagus nerve, which is the 10th cranial nerve, to change brain activity. Researchers have been exploring the modulation of the vagus nerve for decades to treat a variety of neurological and psychiatric conditions.

One of the most important breakthroughs in VNS research was the finding that stimulating the vagus nerve could help people with treatment-resistant seizure disorders. In 1997, the FDA approved the first VNS device by Cyberonics for the treatment of refractory epilepsy in adults and children as young as age 12. In 2017, LivaNova created a smaller VNS device that is now approved for refractory epilepsy for ages 4 and above. A metanalysis of the efficacy of VNS for treatment-resistant seizure disorders showed an impressive average reduction of seizures of 51% after 1 year of treatment .

Another critical finding in VNS research was that stimulating the vagus nerve could help treatment-resistant depression. In 2005, the FDA approved a VNS device by Cyberonics for the treatment of severe, treatment-resistant unipolar and bipolar depression as an adjunctive treatment for people age 18 and older. In this approval, the FDA defined treatment resistance as having failed 4 or more antidepressant trials. In 2019, LivaNovas device was approved for treatment-resistant depression for the same age range.

Is The Fisher Wallace Stimulator Safe

The Fisher Wallace Stimulator uses a gentle electrical current that is likely safe for regular use, though there are a few things you must consider before use.

Those with implanted medical devices like nerve stimulators or pacemakers should avoid using the Fisher Wallace Stimulator as it may interfere with their ability to function properly.

The company also recommends avoiding the Stimulator if you have a heart condition or have reacted poorly electrical stimulation in the past. The company also mentions skin irritation as a possibility if electrodes are not sufficiently wet prior to placement.

The following side effects were reported in this review:

  • Worsened symptoms of depression
  • Tingling or itching of ears and temples
  • Scalp irritation
  • Dizziness

Depression, anxiety, and insomnia all have the potential to negatively impact your quality of life. As the research for the Fisher Wallace Stimulator is not compelling, at best, it may be part of being ore comprehensive treatment plan.

For these reasons, you should include your doctor in your management plan.

Clinical Applications Of Ces

CES has predominantly been used for the relief of symptoms accompanying three clinical disorders: insomnia, anxiety, and depression. While hundreds of studies have been published examining the effects of CES on insomnia, depression, and anxiety, most are inadequately designed and show a high risk of bias according to the Cochrane criteria . To mitigate these biases, in our review we primarily consider placebo-controlled randomized clinical trials with objective measures, similarly to what was done in recent reviews by the Department of Veterans Affairs .

Also Check: Biological Causes Of Major Depressive Disorder

What Does Tdcs Feel Like

Depending on external and internal factors such as electrode placement, level of current,and length of the tDCS session, feelings may differ between people. However, commonly reported sensations include itching, warming, and tingling feelings at the source of the electrodes, of which can be reduced through application of saline solution.Despite these minor sensations, tDCS is generally a positive experience that does not inflict any pain or feelings of discomfort.

Brain Implant May Lift Most Severe Depression

Depression Treatment  Fisher Wallace

Health editor, BBC News online

An electrical implant that sits in the skull and is wired to the brain can detect and treat severe depression, US scientists believe after promising results with a first patient.

Sarah, who is 36, had the device fitted more than a year ago and says it has turned her life around.

The matchbox-sized pack in her head is always “on” but only delivers an impulse when it senses she may need it.

The experimental study is described in Nature Medicine journal.

The researchers, from University of California, San Francisco, stress it is too soon to say if it might help other patients, like Sarah, with hard-to-treat depression, but they are hopeful and plan more trials.

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What Dopeople Say About Fisher Wallace Depression Treatment

Excellentreviews have been recorded from users this device. One of the buyers states,over eight years and half dozen antidepressants. Later I tried this device,and I fell 100% normal. Im in my fifth week using this device, and it has beenabsolute Godsend!Oneof the renowned celebrities, singer Carly Simon, is quite a fan of this device.She says it helped her to ward off depression and mania.

A Pacemaker For The Brain: No Treatment Helped Her Depression Until This

Its the first study of individualized brain stimulation to treat severe depression. Sarahs case raises the possibility the method may help people who dont respond to other therapies.

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Using Your Fisher Wallace Stimulator

The Fisher Wallace Stimulator is alleged to improve depression, anxiety, and insomnia by administering about 1 4 mA of electricity through electrodes placed at your temples. According to the company, you may feel nothing at all or a slight tingling at the electrode sites.

If you do not have a medical device implanted in your head, neck, or heart, and youre 21 years of age or older, you may be qualified to use the Fisher Wallace Stimulator.

Keep in mind that the FDA requires authorization from a licensed medical provider before you use the device. To receive authorization, speak with your doctor in person or schedule an $18 telemedicine visit with a provider through the companys website.

When youve received the appropriate clearance, your Stimulator can be shipped.

Using your device is fairly straightforward if you pay careful consideration to the following steps:

  • Ensure you place 2 AA batteries
  • Plug one end of the wires into the device, and attach the electrode receptacles to the other end of the wires
  • Submerge the sponge receptacles into a cup of water or run them under the faucet
  • Ensure your headband is properly fitted
  • Slide the sponge electrode underneath the headband and ensure that the bottom of the electrode is above the top of the ear
  • Power on the device to level 2.
  • Feel free to read, watch TV, or meditate during your session.
  • After 20 minutes, the device will shut off automatically . Rotate the dial clockwise into the off position.
  • Fda Panel Looks At Trials Of Devices To Treat Depression

    New device claims to stimulate brain for depression treatment

    GAITHERSBURG, Md. — An FDA advisory panel met Friday to discuss how to analyze trials designed to test devices used to treat depression, but didn’t offer the FDA any clear-cut guidance.

    The Neurological Devices Panel — an outside group of neurologists, psychiatrists, and statisticians — was tasked with advising the FDA on what guidelines researchers should have to adhere to when conducting trials on the safety and efficacy of devices to treat depression.

    That includes devices used in electroconvulsive therapy, vagus nerve stimulation, repetitive transcranial magnetic stimulation, and cranial electrotherapy stimulation.

    Although the agency has clear expectations when it comes to drug trials, it lacks such a requirement for approving devices to treat depression. For instance, the FDA requires a company to submit two positive and well-controlled trials for anti-depressants, but has no similar requirement for devices.

    Major depressive disorder effects more than 14 million people in the U.S. each year, and more than 16% of all Americans will suffer from depression at some point in their lives, according to the FDA.

    Between 15% and 30% of depressed people do not respond to anti-depressants such as selective serotonin reuptake inhibitors , serotonin and norephinephine reuptake inhibitors, and monoamine oxidase inhibitors , according to an FDA staff presentation.

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    Ces For Clinical Insomnia

    The four sham-controlled randomized clinical trials using CES to treat insomnia reveal inconsistent results. One study involving 57 active-duty service member participants showed no significant change in hours of sleep time following a 5-day CES treatment relative to sham . This study used the Alpha-Stim SCS device with two electrodes attached to bilateral earlobes, and the sham condition involved an inactive device. No comparative assessment of cutaneous perception was reported. The authors suggested the CES treatment may not have been sufficient intensity to induce reliable effects on sleep, though to our knowledge no follow-up study was conducted.

    Studying Depression And Key Brain Areas

    Dr. Chang explains what made the researchers focus on the orbitofrontal cortex in this study. The area has been called one of the least understood regions in the brain, he reports, but it is richly connected to various brain structures linked to mood, depression, and decision-making, making it very well positioned to coordinate activity between emotion and cognition.

    The team had access to a clinic that specializes in epilepsy. People with epilepsy have electrodes surgically implanted in their brains as part of routine preparation for surgery.

    For this study, Dr. Chang and team recruited 25 participants with epilepsy who also had mild to severe depression.

    With the electrodes already in place, the participants reported how they were feeling a few times per day using an app. This enabled the researchers to link changes in brain activity with different moods, focusing on the brain area that was most involved in depression and also accessible with DBS.

    The scientists also used mild electrical stimulation on different brain regions and asked participants to say how it affected their mood using specific keywords.

    Afterward, they with the help of a specific piece of software quantified and analyzed the words that the volunteers had used.

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    Ces For Clinical Depression

    A review of CES applications for depression revealed a severe lack of rigorous randomized placebo-controlled clinical trials, and a tendency to use non-standard instruments for diagnosing and monitoring depression symptoms . In fact, of the 270 published reports on CES effects on depression, none of them reached the Cochrane quality criteria . This was largely due to a failure to use standardized diagnostic criteria , lack of sufficient participant blinding , high rates of comorbidity , or consideration of only institutionalized patients with severe refractory depression .

    Two relatively high-quality publications are worth mentioning. In the first study, a group of 16 participants with depression received either sham or active CES using the Fisher Wallace Cranial Stimulator device with two electrodes placed over bilateral temples for 10 days , in a randomized, double-blind, placebo-controlled design . The sham group received active stimulation until the participant reported a tingling sensation on the scalp, and then the device was disabled for the remainder of the session no details were reported regarding potential differences in vestibular or cutaneous sensations between the control and sham groups. Results showed significant reductions in depressive symptoms for the active but not sham CES group at the end of week 2, measured using the BDI. These results should be interpreted with caution, however, given the relatively small sample size .

    Help For Service Members And Veterans

    TDCS Device vs. Fisher Wallace Device

    Dr. Raab, who previously practiced at the Charlotte County Veteran Services before joining Lee Physician Group, says CES has proved an effective non-drug treatment option for many patients who are veterans and service members.

    CES has long been prescribed for the treatment of anxiety, insomnia and depression, he says.

    Recently, Lee Health celebrated its first-year clinical partnership with Home Base Southwest Florida Clinic to provide mental health services for veterans, service members and military families.

    To learn more about clinical services offered by Home Base SWFLs Outpatient Clinic at Lee Health, contact Home Base SWFLs Operation & Special Projects Manager Monique Hashimoto at , 239-338-8389, or visit www.homebase.org/SWFL

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    Why I Get My Brain Zapped

    Conventional therapies haven’t done much good for my anxiety disorder

    Almost seven percent of U.S. adultsabout 15.7 million peopleare diagnosed with major depression disorder, according to the National Institute of Mental Health . The Centers for Disease Control and Prevention report that depression causes 200 million lost workdays each year at a cost to employers of between $17 billion and $44 billion. The statistics for anxiety disorders are not great either. The most common mental illnesses in the U.S., they affect 40 million adults age 18 and older, costing the economy more than $42 billion a year.

    In my twenties, I developed panic disorder. I failed to get better on most medications and therapy. As I reported in an article earlier this year, it took me years to find a medication that worked. Because it took me so long to be diagnosed and treated properly, I have always been interested in alternative treatments for depression and anxiety.

    Two years ago I attended two sessions at the World Science Festival on the use of electrical therapy to treat depression and anxiety. The first event was Spark of Genius? Awakening a Better Brain, a panel discussion moderated by ABC News Chief Health & Medical Editor Richard Besser. The panel discussed what is known about treating the brain and the ethical and legal complications of brain enhancement.

    The views expressed are those of the author and are not necessarily those of Scientific American.

    Risk Of Bias In Clinical Trials

    The Cochrane Collaboration has developed guidelines and software tools for assessing the risk of bias in clinical trials . Five domains of bias are identified: bias arising from the randomization process, bias due to deviations from intended interventions, bias due to missing outcome data, bias in measurement of the reported outcome, and bias in selection of the reported result. In our review of the CES literature, we found several examples of these potential biases. Many studies did not use random selection, had missing outcome data due to data loss or participant attrition, used non-standardized outcome measures with high subjectivity, and/or did not comprehensively report all results. For these reasons, reviews of CES effects conforming to the Cochrane guidelines are severely limited in the number of studies that can be included in a review.

    For example, in a review and meta-analysis of non-invasive brain stimulation effects on chronic pain, applying the Cochrane guidelines resulted no single CES study being judged as having a low risk of bias . Even when including potentially biased studies, the meta-analysis demonstrated no significant advantage of CES relative to placebo. Similarly, a Cochrane review of CES for headache therapy revealed only one study that fit Cochrane criteria, though baseline group differences limited results interpretation .

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    Modeling Ces Effects On The Central Nervous System

    Computer-based modeling provides the opportunity to assess three critical questions regarding CES: does electrical current administered via CES reach cortical and/or subcortical brain regions, where are the effects of current propagation most and least pronounced, and how do morphological differences affect current flow across individuals? A few published papers explore these questions through computational modeling approaches.

    The first model of CES current propagation predicted current density across four concentric anatomical spheres capturing the scalp, skull, cerebrospinal fluid, and cortical tissue . The authors were interested in whether applied electrical current might be dissipated over the surface of the scalp during stimulation, rendering little if any effect on underlying cortical tissue. The authors found that the maximum current density to reach relatively deep brain structures with a 1 mA intensity is ~5 A/cm2 . This reported V/m value is exceedingly high and likely inaccurate, pointing to the need for more modern modeling tools. However, this model did provide the first evidence that at least a portion of electrical current administered via CES reaches cortical brain regions. It did not, however, provide insights into the relative spatial distribution of current over various anatomical structures, or how morphological variation might impact current flow.

    Potential Conflicts Of Interest

    Generating clinical evidence for a medical device to treat anxiety and depression

    Conflicts of interest occur when professional judgments or actions regarding a primary interest are influenced by a secondary interest . For example, a primary interest to conduct research in a sound, methodical, and honest manner may be unduly influenced by a secondary interest of financial gain, promotion, or recognition. Conflicts of interest can arise when an investigator is also a patient’s physician, and/or when they stand to benefit from the success of an investigated drug or therapy.

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    A Lifetime Of Depression

    Tommy Van Brocklin, 60, has suffered from depression since he was 15. In 1975, they didnt have the medication and understanding they do now, he said. I was told I wasnt trying hard enough.

    Ive functioned all these years, but its been very difficult at times, the civil engineer added. Talk therapy helped for about half a day after an appointment. When selective serotonin reuptake inhibitors became available in the 1990s, he started on paroxetine, commonly sold under the brand name Paxil.

    It worked like a miracle drug, he said, but after 10 or 15 years it started to lose its effect. After 25 years, it stopped working entirely. He tried other medications, but none helped one even made him suicidal.

    His sister, who lives near Stanford, connected him with the researchers studying SAINT. He flew from his home in Memphis, Tennessee, and underwent the treatment in September. He felt nothing the first day on day two, he began feeling emotional I felt the struggle of what Id been through all these years.

    The next day, all of a sudden, it broke through, he said. I felt so much better, and its stuck with me.

    History Of Vns In Psychiatry

    Early antidepressant signals. VNS was approved for pharmacoresistant epilepsy in Europe in 1994 and in the US in 1997. Anecdotal clinical observations of mood improvement in epilepsy patients, even in the absence of better control of seizures after VNS implantation, led to a pilot prospective study of VNS effects on mood in epilepsy patients, treated either with the VNS device or anti-epileptic drugs. Significant mood improvement was found in the VNS group at three months, which appeared to be independent of any improvement in seizure control, suggesting that VNS was having a separate and distinct effect on depressive symptoms. The same finding was independently reported in a European study at about the same time with a group of epilepsy patients with mild depression. Following VNS implantation, the proportion of patients with clinically significant depression on the Montgomery Asberg Depression Rating Scale fell from 9 out of 11 at baseline to only 2 out of 10 at the six-month follow up. In contrast, only 2 of 11 subjects in the trial could be classified as responders in terms of seizure reduction over the six months.

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