Tag: Medical device

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Perinatal Mental Health Detection and Prediction Using Mobile Sensing Data: Systematic Review

Background: Perinatal mental health disorders affect approximately 20% of pregnant and postpartum individuals, and are associated with substantial maternal and infant morbidity. Traditional assessment relies on infrequent, subjective self-reports. Mobile devices, including smartphones and wearables, offer opportunities for continuous and objective measurement, but evidence on their assessment utility in perinatal populations remains fragmented. Objective: This review aimed to examine the application of wearable devices and smartphones for detecting and predicting perinatal mental health outcomes, with emphasis on predictive performance, informative features, and methodological rigor. Methods: We conducted a systematic review following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines (PROSPERO CRD420251249218). Six databases (PubMed, Web of Science, Scopus, PsycINFO, IEEE Xplore, and ACM Digital Library) were searched initially in January 2026 and supplemented by an amended search in June 2026, with no publication date restrictions. Evidence was synthesized narratively, and the risk of bias was assessed using PROBAST+AI (Prediction Model Risk of Bias Assessment Tool With AI extension). Results: The initial and supplementary searches yielded 1952 unique records after deduplication, of which 10 studies met the inclusion criteria. The included studies covered postpartum depression, prenatal stress, discrete emotions during pregnancy (eg, happiness, anxiety, and sadness), and maternal loneliness. High discrimination metrics were reported for postpartum depression in individual studies, including a multiclass area under the curve of 0.85, a binary area under the curve of 0.871, and an -score of 0.9872. Heart rate variability, GPS-derived mobility, physical activity, and sleep features were most frequently reported as useful, and their interpretation requires perinatal-specific contextualization. Methodological quality was limited, with 80% (12/15) of PROBAST+AI assessment units rated as having high overall quality concern or risk of bias, mainly due to small samples, limited validation, inadequate handling of missing data, and potential overfitting in the analysis domain. Conclusions: Mobile sensing shows preliminary potential for perinatal mental health assessment, but current evidence does not yet support clinical screening or decision-making, and independent external validation in perinatal populations is currently lacking. Progress toward clinical utility requires broader mental health outcome coverage, larger longitudinal cohorts, standardized analytical and reporting practices, adoption of modeling approaches better suited to perinatal trajectories, independent external validation, and human-centered monitoring designs.
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Effect of transcranial alternating current stimulation (NET Device™) on psychostimulant withdrawal severity and time course: a real-world data analysis

BackgroundPsychostimulant use disorder is a life-threatening condition with no FDA-approved treatment. Stimulant withdrawal symptoms impede treatment engagement and are unaddressed by standard of care. The NET Device, a non-invasive transcranial alternating current stimulator, is FDA-cleared for opioid withdrawal suppression. No studies have evaluated whether NET Device use attenuates psychostimulant withdrawal.MethodsElectronic health record and device utilization data were collected from 109 stimulant-only users and 112 stimulant/opioid co-users (N = 221 adults total; Mage=39.2, SDage=10.7; 119M) entering residential addiction treatment (n = 168) or detention centers (n = 53). The Amphetamine Cessation Symptom Assessment (ACSA) was administered at baseline and 1 hour (day 1), and twice daily on days 1–7. A linear mixed model (LMM) with random intercepts and slopes was used to analyze the trajectory of ACSA scores.ResultsACSA severity and time course were similar across settings (residential vs. detention). A two-phase LMM separated acute (baseline to 1 hour) and post-acute withdrawal symptom reductions. Relative to baseline ACSA scores, stimulant-only and co-user groups each reported significant reductions at 1 hour (46% and 33%), day 2 morning (59% and 42%), and decelerating log-time trajectory through day 4 (79 hours), the primary analysis window. Estimates beyond day 4 rest on 6.9% of observations and are reported as exploratory only.ConclusionNET Device monotherapy was associated with rapid reduction in psychostimulant withdrawal severity regardless of setting and opioid co-use. No device-related adverse events were reported. These real-world data support initiation of a sham-controlled randomized trial to evaluate NET Device efficacy for stimulant use disorder.
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Interventional rTMS for Improving Social Perception in Autism

Conditions: Autism Spectrum Disorders (ASD)

Interventions: Device: Neuromodulation by transcranial magnetic stimulation (TMS); Radiation: Anatomo-functional MRI; Device: Eye-tracking; Other: Social Responsiveness Scale, Second Edition (SRS-2)

Sponsors: Assistance Publique – Hôpitaux de Paris; URC-CIC Paris Descartes Necker Cochin

Not yet recruiting
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Rapid Entrainment and Signal-guided Neuromodulation for Behavioral Health

Conditions: Anxiety; PTSD; ADHD; Depression Disorders; Post-traumatic Stress; Substance Use; Executive Function; Sleep Disturbance

Interventions: Behavioral: AIP-Informed Integrative Psychotherapy; Device: Transcutaneous Auricular Vagus Nerve Stimulation; Behavioral: Regulated Breathing and Autonomic Regulation; Device: Audiovisual Entrainment; Device: Vibroacoustic Stimulation; Behavioral: Breathwork-Based Auditory Driving Entropy Module (BADEM); Device: Transcranial Electrical Stimulation

Sponsors: Tactical Mind Research Coalition, Inc.

Active, not recruiting
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Immersive wearable virtual reality for autism: a systematic review of current evidence

IntroductionImmersive and wearable virtual reality (VR) is an emerging technology with growing potential to support assessment and intervention ifor autistic people. The methodological heterogeneity of existing studies limits the interpretation and generalization of current evidence.MethodsA systematic review with a narrative synthesis was conducted in accordance with the PRISMA guidelines. Electronic searches were performed in PubMed, Scopus, IEEE Xplore, Web of Science, and Google Scholar, identifying studies published between 2015 and August 2025. Twenty-two studies investigating wearable and immersive VR interventions in children and adults with ASD met the eligibility criteria.ResultsThe included studies demonstrated that wearable VR interventions may improve social communication, joint attention, emotional regulation, daily living skills, executive functioning, and user engagement. Innovative technologies, including eye-tracking and artificial intelligence-based systems, also enabled objective assessment of gaze behaviour, social interaction, and physiological responses. Nevertheless, the evidence was characterized by considerable methodological heterogeneity, predominantly small sample sizes, limited use of randomized controlled designs, and scarce long-term follow-up, reducing the generalizability of the findings.DiscussionWearable VR represents a promising tool for personalized assessment and intervention in ASD. Based on the current evidence, we propose a structured pre-intervention assessment integrating sensory, cognitive, emotional, and VR tolerance profiles to support individualized intervention planning. Future research should prioritize standardized outcome measures, rigorous study designs, and longitudinal investigations to strengthen the clinical translation of VR-based interventions in autism.
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Latest developments in the use of e-cigarettes by people with schizophrenia spectrum disorders who smoke: a scoping review

BackgroundTobacco use is significantly more prevalent among individuals with schizophrenia spectrum disorders (SSD) compared to the general population, contributing to elevated rates of premature mortality from smoking-related diseases. Despite a decline in smoking prevalence in the general population, individuals with SSD continue to smoke at persistently high rates, driven by biological, psychological, and social factors. Standard smoking cessation approaches yield markedly poorer outcomes in this group compared to non-psychiatric populations. This scoping review aimed to map the emerging evidence on the use of e-cigarettes among individuals with SSD or serious mental illness (SMI).MethodsThis scoping review was conducted in accordance with the Population–Concept–Context (PCC) framework and reported following the PRISMA extension for Scoping Reviews (PRISMA-ScR) guidelines. The review focused on studies published between January 2020 and February 2026, searched on PubMed and EMBASE, providing an up-to-date synthesis of emerging evidence on e-cigarette use in this vulnerable population.ResultsThree studies reported across four publications were included (total N = 323); one research group (Pratt et al.) contributed two separate publications reporting distinct outcomes from the same study cohort. Findings suggest that e-cigarette-based interventions are feasible and acceptable in individuals with SSD and SMI, with preliminary evidence of smoking reduction and decreased exposure to tobacco-related carcinogens. However, sustained harm reduction appeared dependent on a combined approach considering that device provision was empowered in its efficacy to sustain harm reduction over time when integrated with behavioral support.ConclusionsThe available evidence, while preliminary and limited by the small number of included studies, should be interpreted with caution regarding generalizability to patients with Schizophrenia Spectrum Disorders exclusively, as three of the four included publications recruited participants with broader SMI diagnoses of which SSD represents only a subset. Further research, including larger adequately powered trials with standardized outcome measures and longer follow-up, is needed to establish the generalizability and long-term impact of these interventions.
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VR-Based Behavioral Activation in Adults

Conditions: Depression – Major Depressive Disorder; Behavioral Activation; Virtual Reality Therapy; Behavioral Inhibition

Interventions: Device: Virtual Reality Behavioral Activation Software; Behavioral: Waitlist Control and Psychoeducation

Sponsors: KTO Karatay University

Completed