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

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

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

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

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

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!

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.