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Non-Invasive Vagus Nerve Stimulation for Treatment of Posttraumatic Stress Disorder

adults, Posttraumatic Stress Disorder, PTSD

A Vagus Nerve Stimulation(nVNS) device called gammaCore™, this week has received a Breakthrough Designation from the U.S. Food and Drug Administration (FDA) for the treatment of posttraumatic stress disorder (PTSD) after showing a reduction of symptoms of PTSD by 31% when compared to sham treatment.

The Breakthrough Device Designation was supported, in part, by research from an Emory-Georgia Tech team led by J. Douglas Bremner, M.D., in the Departments of Psychiatry and Radiology at the Emory University School of Medicine, and Omer T. Inan, Ph.D., from the School of Electrical and Computer Engineering and the Coulter Department of Biomedical Engineering at the Georgia Institute of Technology in Atlanta, Georgia. Their research, built upon a strong mechanistic rationale and animal studies, shows nVNS blocks sympathetic and inflammatory responses to memories of traumatic events in patients with PTSD, modulates brain responses to traumatic memory, and reduces symptoms of PTSD by 31% when compared to a sham stimulation.

The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to critical medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA’s mission to protect and promote public health.

Why PTSD?

PTSD is a highly prevalent and disabling disorder with limited approved treatment options. According to the U.S. Department of Veterans Affairs National Center for PTSD, approximately 15 million adults in the U.S. experience PTSD each year. In the Military and Veterans Administration alone, PTSD is reported to affect between 10-20% of veterans who served in each Operations Iraqi Freedom (OIF) and Enduring Freedom (OEF), the Gulf War (Desert Storm), and the Vietnam War. More than half of all patients with PTSD report severely impaired quality of life in areas including mood, social and family relationships, leisure activities, sense of well-being and life satisfaction.

According to one of the investigators, Dr. Douglas Bremner commented, “Current treatments for PTSD involving medication and psychotherapy have limitations due to limited efficacy, possible side effects, and the unwillingness of many PTSD patients to engage in therapies that involve reliving traumatic memories. gammaCore represents a new class of treatment separate from medication or psychotherapy that is safe, relatively free of side effects, and does not involve costly and invasive procedures for implantation, like previous VNS devices approved by the FDA for treatment of refractory depression.”

Gammacore device has been previously approved by the FDA for: (Source: https://www.gammacore.com/)

Migraine – Clinically proven to treat and prevent migraines in users ages 12 and up. Help reduce migraines days without additional drugs.

Cluster Headache – The only clinically proven device to treat and prevent cluster headache attacks, while providing fast, reliable relief for those suffering with cluster headache.

Hemicrania Continua (HC) & Paroxysmal Hemicrania (PH) – 1st and ONLY device for HC and PH treatment, proven to reduce pain severity or headache frequency.

COVID-19 – Emergency Use Authorization to treat users with known or suspected COVID-19 and experiencing reduced airflow.

Sources:

FDA
Fact sheet for healthcare workers

Instructions for use of gammaCore

gammaCore™ Press release

Exploring problematic smartphone use during pandemic

Apps, smartphones, Social Media, Social Media Use, texting access

Smartphones have become people’s daily companions and an integral part of our lives and interactions with information and other people. Through mobile Internet access, smartphones allow quick access and provide up-to-date news around the globe and in the life of family and friends.  In addition to the active online interaction, one can passively observe the online behavior of others by checking their updates and depending on privacy settings, we can track when our friends are online, and whether they have read our recent messages. 

Essentially “smartphones not only satisfy our need for belonging; they also can contribute to the satisfaction of another important human need—the sense of control.” Previous research has demonstrated that smartphone use has significantly increased during the COVID-19 pandemic. While smartphones can enhance daily routines and social connection, studies has also shown that smartphone use can become problematic and negatively affect relationships, work, and mental or physical health. A more complete understanding of factors that may contribute to problematic smartphone use (PSU) could help inform efforts to prevent and manage such behavior.

To provide new insights, researchers from the University of Bochum in Germany conducted an online survey of 516 smartphone users aged 18 and over in Germany in April and May of 2021. The survey included questions to evaluate self-reported smartphone use as well as sense of control, fear of missing out, and repetitive negative thinking—three factors that the researchers hypothesized could contribute to problematic smartphone use, particularly during the COVID-19 pandemic. 

Statistical analysis of the survey results found that those individuals who reported experiencing low sense of control, fear of missing out, and repetitive negative thinking,and indeed, all were associated with greater severity of problematic smartphone use.

Moderating effect of repetitive negative thinking on the connection between fear of missing out and problematic smartphone use (N = 516).

While the findings do not prove causation, the statistical analysis also suggested possible interactions between the four factors. For one, fear of missing out may be a key mechanism by which low sense of control could lead to problematic smartphone use. Meanwhile, a higher degree of repetitive negative thinking was associated with a stronger relationship between fear of missing out and problematic smartphone use.

The sample was comprised of mostly female and rather young participants; the authors suggest that the study should be replicated in more age and gender balanced samples from other countries, to ensure the results are generalizable to other populations. Furthermore, the study was conducted during the pandemic when participants’ usual daily routines may have been disrupted, possibly affecting the participants’ sense of control. Nonetheless, the findings are in line with the hypothesis that loss of control—as experienced by some during the pandemic—could boost the risk of problematic smartphone use.

Source: Brailovskaia J, Stirnberg J, Rozgonjuk D, Margraf J, Elhai JD (2021) From low sense of control to problematic smartphone use severity during Covid-19 outbreak: The mediating role of fear of missing out and the moderating role of repetitive negative thinking. PLoS ONE 16(12): e0261023. https://doi.org/10.1371/journal.pone.0261023

Social media use shown to be linked to depression in adults

adults, facebook, Major depression, Snapchat, Social Media, Social Media Use, TikTok

Data shows that individuals over age 35 were mostly likely to be negatively affected by highly visual apps, such as TikTok and Snapchat.

A number of recent studies have focused on adolescents and young adults being negatively affected by frequent use of social media. Symptoms of diminished well-being and greater levels of anxiety and depression were commonly reported. A research question asked if these same symptoms might apply to older consumers of social media.

To investigate this question, data from multiple waves of an ongoing 50-state US survey as used. The surveys, conducted from May 2020 through May 2021, were initially focused on learning more about how adults were coping during the Covid-19 pandemic. Over time, researchers increasingly became interested in whether social media use might be linked to changes in mental health.

The survey initially asked people who were not expressing depressed feelings about their social media use, with subsequent queries to see if the people who were using certain kinds of social media were more likely to be depressed. The research does not prove social media causes depression. Indeed, it is possible that people already prone to feeling sad were more likely to log on to such sites.

Compared to adults who did not use social media, “people who were using Facebook, people who were using TikTok, and people who were using Snapchat were substantially more likely to come back and tell us they felt depressed the next time they filled out the survey,” reported Roy H Perlis, MD, a professor of psychiatry at Harvard Medical School and Massachusetts General Hospital.

The research also found age differences in how certain platforms impacted mental health. Depressive symptoms were more commonly reported among Facebook users under age 35 than older adults. The opposite was true for users of Snapchat and TikTok more depressive symptoms were reported among people over age 35.

The reasons for such findings were unclear. It could be that because Snapchat and TikTok are more visual mediums, perhaps affecting older adults differently. Or it could suggest that a person is out of sync with his or her peers. Perlis said more research is needed to interpret the results appropriately. Ultimately, experts recommend remaining mindful of time spent on social media.

The authors concluded that  “Among survey respondents who did not report depressive symptoms initially, social media use was associated with greater likelihood of subsequent increase in depressive symptoms after adjustment for sociodemographic features and news sources. These data cannot elucidate the nature of this association, but suggest the need for further study to understand how social media use may factor into depression among adults.”

Mitch Prinstein, PhD, chief science officer for the American Psychological Association commenting on this research pointed out that “Our brains were not built for this kind of social interaction. And social media is kind of hijacking the need for social interaction with something very artificial and insufficient,” he said. “Social media is the empty calories of social interaction.”

Sources:

Perils RH, Green J, Simonsson M, et al. Association Between Social Media Use and Self-reported Symptoms of Depression in US Adults. JAMA Netw Open. 2021;4(11):e2136113. doi:10.1001/jamanetworkopen.2021.36113

NBC News

FCC Votes to Allow Texting ‘988’ to Reach the National Suicide Prevention Lifeline Beginning July 2022

Major depression, Suicide, suicide hot line, texting access

On July 16, 2020, the FCC adopted rules to establish 988 as the new, nationwide, easy-to-remember 3-digit phone number for Americans in crisis to connect with suicide prevention and mental health crisis counselors.

Texting will be able to access suicide hotline help

This week, U.S. communications regulators will require that phone companies allow people to text as well as call a new “988” number for the suicide-prevention hotline. In recognition of the changing trend in technology use by youth, texting 988 will also be a way to reach the hotline. This would also benefit those who are deaf, have hearing loss or speech disabilities.

According to FCC Acting Chairwoman Jessica Rosenworcel, “For millions of us, especially young people and those with disabilities — they are more likely to text than they are to call when they are in crisis. The bottom line is it should not matter when you make a voice call or send a text message, because we should connect people in crisis to the resources they need, no matter how they communicate.”

Currently, the National Suicide Prevention Lifeline uses a 10-digit number, 800-273-TALK (8255), which routes calls to about 170 crisis centers. Phone companies have until July 2022 to implement the 988 number for both calling and texting. The FCC said Thursday that the country’s largest cellphone companies already support calling 988. The implementation of a three-digit number for the National Suicide Prevention Lifeline comes as suicide is a growing public health problem in the United States, with risk factors compounded by the Covid-19 pandemic.

It is estimated that nearly 6,000 Americans call the Lifeline on an average day. The most recent report (2020) by the National Center for Health Statistics, describes more than 45,000 suicide deaths in the US. While there was an overall decrease in suicides by 3% from 2019 to 2020 — suicide rates increased for non-Hispanic Black, non-Hispanic American Indian and Alaska Native, and Hispanic men, according to the NCHS report

Sources:

FCC News

FCC Report and Order

NCHS suicide report 2020

988 Fact Sheet: [ English | Spanish ]

FDA’s Breakthrough Device Designation for rapid-acting technology to treat major depression

Uncategorized

Non-invasive neurostimulation technology to rapidly treat major depressive disorder (MDD) 

The FDA has awarded Breakthrough Device Designation to Magnus Medical’s non-invasive technology to rapidly treat major depressive disorder (MDD) in adults who have not responded to existing treatments. The Magnus System is based on the SAINT technology (Stanford Accelerated Intelligent Neuromodulation Therapy), a form of transcranial magnetic stimulation which was licensed exclusively to Magnus Medical from Stanford University for commercialization.

An advance online article published in the American Journal of Psychiatry, describe the results from an investigational double-blinded randomized controlled trial (RCT) evaluating SAINT suggest that the novel approach has the potential to be a reproducible, rapid, and highly effective treatment for severe, refractory depression in a broader clinical setting. Fourteen study participants received active treatment, and another 15 received sham (placebo) treatment. The clinical trial results show that 79% of people in the active treatment arm entered remission—that is, experienced near elimination of their depression symptoms based on the Montgomery-Åsberg Depression Rating Scale (MADRS)—compared to people in the sham treatment arm, where only 13% entered remission. In an earlier pilot trial evaluating SAINT, 19 of 21 study participants (90%) entered remission. The restoration of healthy neural activity for the responders was life-changing as indicated by improvement in quality of life measures, and within five days, symptoms (including thoughts of suicide) improved dramatically. Data collected during both studies were evaluated by the FDA as part of the criteria for granting Breakthrough Device designation. 

The SAINT technology is described as having breakthrough algorithms that can identify optimal, personalized targets to affect brain circuitry based on structural and functional neuroimaging. Therefore, utilizing precise patterns of stimulation that can leverage recent advances in neuroscience and restore these neural circuits.

According to Magnus Medical, this system is a novel innovation with the potential to have a significant positive impact on the treatment of severe depression. For the first time, advanced imaging technologies combined with personalized neural targeting and novel stimulation patterns have the potential to yield a new form of individualized, non-invasive neurostimulation for people with treatment-resistant depression. This new approach is designed to be delivered on an accelerated timeline and is precisely tailored to each person’s brain connectivity.

The Magnus System, currently an investigational device, is expected to require 501(k) clearance from the U.S. FDA and is not yet commercially available.

Sources:

Cole EJ, Phillips AL, Bentzley BS, et al. Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial. AJP Published Online:29 Oct 2021

Magnus Medical Press Release

Stanford University News

Columbia University Psychiatry Develops a Mobile Depression App

Apps, Diagnosis, Early Identification, Major depression

A major gap in diagnosing and managing major depression is that the frontline in the recognition of depression is staffed by primary care clinicians. Since depression is one of the leading causes of disability worldwide, busy PCPs can benefit from the latest tools and information to assist them in the assessment and treatment of patients who present with symptoms.

The app known as Columbia Psychiatry Pathways — supports and strengthens the ability of clinicians to provide critical mental health services in an outpatient setting. It was co-developed by Columbia Psychiatry faculty John Mann, MD and Ravi N. Shah, MD. in collaboration with avoMD, a next-gen clinical decision support platform, as an interactive smartphone application that provides point-of-care treatment algorithms for major depression. 

This clinical decision support tool, is available as a mobile and desktop app. It has been developed for use by psychiatrists, primary care physicians, nurse practitioners, physician assistants, medical students, residents, and trainees in outpatient settings as they treat patients with major depression. The evidence-based platform updates prior depression treatment guidelines and uses algorithms that focus on faster medication adjustments with emphasis on the best-tolerated generic antidepressants. It measures symptom severity using built-in calculators based on the Columbia Depression Scale and includes screenings for bipolar disorder and suicide risk. 

The division of primary care at Columbia welcomes the Psychiatry Pathways app and highlight that ‘it is challenging to treat major depression, especially in a primary care setting, especially in a patient with comorbid conditions. A point of care app that can serve as virtual consult can help to validate a PCP’s knowledge in the best possibl care for patients.’

Sources:

Columbia Psychiatry

avoMD

Study to Evaluate Apple Devices For Identifying Early Parkinson’s Disease

Apps, Diagnosis, Early Identification, Parkinson's Disease
Apple Watch PD App

A recent study presented at the virtual International Congress of Parkinson’s Disease and Movement Disorders 2021, demonstrated that Apple Watches and iPhones can differentiate between individuals with early, untreated Parkinson’s disease (PD) and healthy controls.

The 12-month study included 132 individuals at 17 Parkinson’s Study Group sites, 82 with PD and 50 controls. Ages of the participants were approximately the same in the PD and control groups (63.3 years vs 60.2 years, respectively), but male to female ratios differed between the groups. There were more men in the PD cohort (56% men vs 44% women) and more women in the control cohort (36% vs 64%; P =.03).

Participants with PD were untreated, were no more than 2 years out from diagnosis (mean disease duration, 10.0 ±7.3 months), and were in Hoehn and Yahr stage 1 or 2. Apple Watches and iPhones were provided to participants, all of whom underwent in-clinic assessments at baseline and at months 1, 3, 6, 9, and 12. The assessments included motor and cognitive tasks using the devices, which contained motion sensors.

The phone also contained an app that could assess verbal, cognitive, and other abilities. Participants also wore a set of inertial sensors (APDM Mobility Lab) while performing the MDS-UPDRS Part III motor examination. In addition, there were bi-weekly at-home tasks. Questions and tests on the watch assessed symptoms of mood, fatigue, cognition, and falls as well as cognitive performance involving perceptual, verbal, visual spatial, and fine motor abilities. Both the watch and iPhone were used to gauge gait, balance, and tremor.

The authors concluded that “the WATCH-PD trial is one of the first multi-center, prospective, longitudinal digital markers studies in untreated early PD patients. Preliminary analyses show that devices can differentiate between individuals with early, untreated PD and controls. Further analyses of longitudinal data may provide additional insights including the utility of wearable and mobile devices for measuring functional outcomes in clinical trials.”

Source:

J. Adams, E. Dorsey, T. Ruiz Herrero, WATCH-PD: Wearable Assessments in the Clinic and Home in Parkinson’s Disease: Baseline Analyses [Abstract 364]. Mov Disord. 2021; 36 (suppl 1). https://www.mdsabstracts.org/abstract/watch-pd-wearable-assessments-in-the-clinic-and-home-in-parkinsons-disease-baseline-analyses/. Accessed September 25, 2021.

Instagram Use and Its Association With Self-Esteem and Well-Being

Social Media, Social Media Consequences, Social Media Use

As the presence and use of social media grows, image-based sites have increased in popularity among adolescents and young adults. Research to date has suggested conflicting outcomes of social media use on individuals. A study by social media researchers at Boston University included a sample of 359 college-aged individuals from throughout the United States, sought to analyze the relationship between active social media use and its association with user self-esteem and well-being through data obtained through survey research from undergraduate college students. The hypothesis was that active Instagram use would be positively associated with user well-being and self-esteem.

This study demonstrated that “not only was this hypothesis supported, but our findings reveal that intensity of Instagram use serves as a mediating variable in the relationship between active Instagram use and well-being and self-esteem.” The study shows that “respondents who identified as more active Instagram users used social media more intensely, and those who used social media more intensely had higher self-esteem. Similarly, those who used social media more intensely reported higher levels of well-being.”

Specifically, respondents who identified as more active Instagram users used social media more intensely, and those who used social media more intensely had higher self-esteem. Similarly, those who used social media more intensely reported higher levels of well-being. While the correlations among these variables may be slight, we argue that they pose implications regarding how usage patterns impact user outcomes. These findings illustrate the role of intensity of Instagram usage on user outcomes and reveal a relationship among these variables, where more active Instagram use, coupled with more intense usage, ultimately corresponds to positive effects specifically elevated levels of self-esteem and well-being.

This is particularly interesting since a number of previous studies have correlated intensity of social media use with negative outcomes or consequences. Clearly, additional studies are needed to demonstrate and delineate both the assets and liabilities of social media use and misuse.

Source:

Active Instagram Use and Its Association With Self-Esteem and Well-Being, Trifiro BA and Prena K. Technology, Mind, and Behavior. Volume 2, Issue 3. DOI: 10.1037/tmb0000043.

FTC warns health apps to notify consumers impacted by data breaches

Apps, Comsumer Safety, Cybersecurity, Security

STATEMENT OF THE COMMISSION 

On Breaches by Health Apps and Other Connected Devices 

September 15, 2021 

“In recognition of the proliferation of apps and connected devices that capture sensitive health data, the Federal Trade Commission is providing this Policy Statement to offer guidance on the scope of the FTC’s Health Breach Notification Rule, 16 C.F.R. Part 318 (“the Rule”).1 

The FTC’s Health Breach Notification Rule helps to ensure that entities who are not covered by the Health Insurance Portability and Accountability Act (“HIPAA”) nevertheless face accountability when consumers’ sensitive health information is compromised. Under the Rule’s requirements, vendors of personal health records (“PHR”) and PHR-related entities must notify U.S. consumers and the FTC, and, in some cases, the media, if there has been a breach of unsecured identifiable health information, or face civil penalties for violations. The Rule also covers service providers to these entities.”

This new policy statement by the FTC is designed to update and clarify the agency’s 2009 Health Breach Notification Rule, which requires vendors handling health records to notify consumers if the data is accessed through a breach or other means without the individual’s authorization. This rule applies to health apps, such as those tracking fitness or menstrual cycles, which have been developed over the past decade. 

“As many Americans turn to apps and other technologies to track diseases, diagnoses, treatment, medications, fitness, fertility, sleep, mental health, diet, and other vital areas, this Rule is more important than ever,” the FTC stated and intends to enforce the new policy, with those in violation facing a financial penalty of over $43,000 per day.  

Sources:

FTC

https://www.ftc.gov/system/files/documents/public_statements/1596364/statement_of_the_commission_on_breaches_by_health_apps_and_other_connected_devices.pdf

The Hill

https://thehill.com/policy/cybersecurity/572485-ftc-warns-health-apps-to-notify-consumers-impacted-by-data-breaches

Engadget

https://www.engadget.com/ftc-rules-that-health-apps-must-notify-consumers-if-their-data-is-breached-114043312.html

AATP Back Online!

Uncategorized

Welcome back to AATP Website.

It has been said that changing emails and website addresses is like changing diapers. It can be messy but necessary.

We needed to move our web hosting service and our previous host did not make it easy. Enough said.

We look forward to re-activating this AATP Blog to keep you informed, engaged and excited about the changes and progress in Technology in Psychiatry and Medicine.

Stay tuned.