Apr 30,2023

Cognito Therapeutics Announces Gamma-Frequency Sensory Stimulation Decreases Brain Atrophy in Patients with Alzheimer’s Disease at AD/PD 2023

Cognito Therapeutics, today announced neuroimaging results evaluating the effects of the company’s non-invasive neuromodulation medical device, which delivers proprietary gamma frequency light and sound stimulation in participants with Alzheimer's disease (AD). Neuroimaging data was prospectively collected in the OVERTURE clinical trial (NCT03556280) along with safety, tolerability, and efficacy of Cognito Therapeutics’ medical device in participants with Alzheimer’s disease. 76 participants were randomized 2:1 to receive daily, one-hour, EEG-assessed, proprietary non-invasive neuromodulation (active arm, n=46) or sham (placebo arm, n=28) stimulation over a 6-month period. A significant reduction in whole brain volume loss was observed, which correlated with reduced lateral ventricle expansion, in subjects in the active compared to the sham group.

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Apr 20,2023

Click Therapeutics Initiates Fully Remote Pivotal Trial Using Investigational Prescription Digital Therapeutics to Treat Episodic Migraine

Click Therapeutics, Inc. today announced the initiation of the ReMMi-D, Reduction in Monthly Migraine Days study, a fully remote and decentralized pivotal trial designed to investigate the efficacy and safety of prescription digital therapeutics in reducing the number of monthly migraine days for adults diagnosed with episodic migraine. ReMMi-D is a completely remote study in which patients receive digital therapy through a mobile application while going through their regular daily activities and allows for a more representative patient population for enrollment. The Phase 3, randomized, double-blind trial will enroll approximately 558 patients in the United States. Trial intervention will be delivered over 12-weeks and efficacy will be evaluated between groups as a change from baseline in the number of monthly migraine days (MMDs).

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Apr 17,2023

Swing Therapeutics Announces Long-Term Effectiveness Data from Studies of Stanza

Swing Therapeutics, a digital therapeutics company developing evidence-backed treatments for chronic pain conditions, announced the publication of new research data supporting the long-term effectiveness of Stanza, its digital therapeutic that delivers behavioral therapy for fibromyalgia management. In the decentralized, single-arm, real-world extension study, fibromyalgia patients continued to use Stanza as needed for therapy maintenance after the main 3-month treatment program, and were evaluated up to 12 months after their treatment initiation. The results showed durable clinical effectiveness of the treatment, evidenced by the maintenance of the immediate treatment effect at Month 3 through to Month 12. Specifically, the proportion of patients improved in fibromyalgia (measured by Patient Global Impression of Change) was consistently above 80% across all follow-up timepoints. The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score also demonstrated substantial and durable improvement, reporting greater than 25% mean improvement across the extension study.

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Apr 12,2023

Barriers to and Facilitators of a Blended Cognitive Behavioral Therapy Program for Depression and Anxiety Based on Experiences of University Students: Qualitative Interview Study

Blended cognitive behavioral therapy (bCBT) programs have been proposed to increase the acceptance and adoption of digital therapeutics (DTx) such as digital health apps. These programs allow for more personalized care by combining regular face-to-face therapy sessions with DTx. However, facilitators of and barriers to the use of DTx in bCBT programs have rarely been examined among students, who are particularly at risk for developing symptoms of depression and anxiety disorders. This study aimed to evaluate the facilitators of and barriers to the use of a bCBT program with the elona therapy app among university students with mild to moderate depression or anxiety symptoms. Semistructured interviews were conducted via videoconference between January 2022 and April 2022 with 102 students from universities in North Rhine-Westphalia, Germany, after they had completed weekly individual cognitive behavioral therapy sessions (25 minutes each) via videoconference for 6 weeks and regularly used the depression (n=67, 65.7%) or anxiety (n=35, 34.3%) module of the app. Students mostly had positive attitudes toward elona therapy as part of the bCBT program. This study shows that DTx complementing face-to-face therapy sessions can be perceived as a helpful tool for university students with mild to moderate anxiety or depression symptoms in their daily lives.

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Apr 12,2023

Nerivio® Proven Effective in Real-World Setting as Drug-Free Acute Treatment of Migraine for Adolescents

Theranica, a digital therapeutics company, published a study in Pediatric Neurology showcasing the real-world effectiveness of its wearable device, Nerivio®, in treating migraines in adolescents. The study analyzed data from 1,629 adolescents using Nerivio for acute migraine treatment over 18 months, demonstrating its ease of use, safety, and efficacy. Results showed that 60.3% of users achieved pain relief, 26.3% became pain-free, and a significant reduction in functional disability was observed. Nerivio is an FDA-cleared wearable device that uses Remote Electrical Neuromodulation (REN) to provide a drug-free alternative for migraine treatment in young adults

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Apr 07,2023

Health4Life eHealth intervention to modify multiple lifestyle risk behaviours among adolescent students in Australia: a cluster-randomised controlled trial

The Lancet Digital Health published a study on the implementation of digital therapeutics (DTx) in clinical trials. The study analyzed data from 12 randomized controlled trials (RCTs) involving 4,760 participants, and found that DTx interventions were effective in improving various health outcomes, such as reducing symptoms of depression, anxiety, and chronic pain. The authors suggest that DTx could be a valuable addition to traditional treatments, and should be further investigated for broader clinical applications

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Mar 23,2023

Clinical Trial of Arcade Therapeutics' Flagship Therapeutic Mobile Game, StarStarter Rx, Shows Robust Reductions in Social Anxiety in Adults

Arcade Therapeutics (formerly Wise Therapeutics) has announced topline results of their StarStarter Rx Pilot Study, evaluating the efficacy and safety of their flagship digital therapeutic in adults aged 22-65 with Social Anxiety Disorder (SAD). The clinical trial showed that StarStarter Rx reduced social anxiety symptoms in over 90% of patients, with a 33% average decrease, which was statistically significantly greater than that of the gold-standard placebo control. 68% of patients showed clinically meaningful reductions in their anxiety severity level, with 38% showing reductions to sub-clinical cutoffs. Arcade plans to pursue FDA submission for StarStarter Rx, which applies the cognitive training technique Attention Bias Modification through an engaging mobile game format

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Mar 14,2023

Dario Publishes New Research Demonstrating Digital Personalization of Pain Management with Adapted Machine Learning

DarioHealth, a leader in digital therapeutics, has published new research in Pain Reports, showcasing the personalized efficacy of digital therapeutics for pain management. The study focused on Dario's posture training program, which utilizes adapted machine learning to personalize user journeys. Data from 3,610 users revealed significant reductions in back pain after three weeks of using the program, with sustained improvement. The research demonstrates the potential of machine learning in analyzing and personalizing pain management solutions, highlighting the effectiveness of Dario's approach in driving healthier behaviors and reducing pain.

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Mar 07,2023

Development and validation of an electronic daily control score for asthma (e-DASTHMA): a real-world direct patient data study

The article, published in the journal Respiratory Research, aims to develop and validate a new electronic tool for assessing asthma control, known as the e-DASTHMA. The e-DASTHMA is a daily electronic questionnaire that assesses asthma control and predicts asthma exacerbation risk. The study includes data from over 1,200 patients with asthma in Europe and North America. The results indicate that the e-DASTHMA is a reliable and valid tool for assessing asthma control. Additionally, the e-DASTHMA is more sensitive than the traditional Asthma Control Test (ACT) in predicting asthma exacerbation risk. The authors suggest that the e-DASTHMA could be useful in supporting patients in self-monitoring and self-management of their asthma. Furthermore, the e-DASTHMA can be used in clinical practice to monitor asthma control and predict exacerbation risk. Overall, the study demonstrates the potential of electronic tools to improve asthma management.

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Feb 03,2023

Developing Digital Therapeutics for Chronic Pain in Primary Care: A Qualitative Human-Centered Design Study of Providers’ Motivations and Challenges

Digital therapeutics are growing as a solution to manage pain for patients; yet, they are underused in primary care where over half of the patients with chronic pain seek care. Little is known about how to successfully engage primary care providers in recommending digital therapeutics to their patients. This study examined primary care providers’ motivations for chronic pain management, including their strategies and challenges, to inform the future development of chronic pain-related digital therapeutics tailored to primary care settings. Researchers conducted qualitative semistructured interviews with health care providers recruited from 3 primary care clinics in Washington and 1 clinic in Colorado between July and October 2021. The sample (N=11) included 7 primary care physicians, 2 behavioral health providers, 1 physician assistant, and 1 nurse. Specifically, providers desired additional resources to improve patient-centered communication, pain education and counseling, and goal setting with patients. Given the findings, to engage primary care providers, digital therapeutics for chronic pain management need to strengthen the patient-provider alliance, increase access to nonpharmacological treatment options, support population health tracking and management, and provide equitable reach.

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