Safety of transcutaneous electrical stimulation potentiating recovery in acute spinal cord injury syndromes: a trial protocol

Background and objectivesSpinal cord injury (SCI) often results in permanent paralysis, leading to substantial long-term disability and loss of quality-adjusted life years. Strategies to preserve neural function in the hyperacute phase are needed. Transcutaneous spinal cord stimulation (tSCS) improves neurological function in chronic SCI. Earlier implementation in acute SCI may preserve or restore function and improve recovery.MethodsSTEP-RAISE is a Phase 1/2 prospective clinical trial evaluating the safety and preliminary efficacy of tSCS in acute moderate-to-severe traumatic SCI. Electrical current will be delivered to the lumbosacral spinal cord using the investigational ARC-Ex device (ONWARD Medical) via surface electrodes over the thoracolumbar region. Phase 2 is a randomized, triple-blinded, placebo-controlled trial designed to assess treatment effects. Safety outcomes include hemodynamics, spinal cord perfusion pressure, and skin reactions. Efficacy will be assessed using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examination with electromyography at baseline, during stimulation, and at 6-month follow-up. Biomarkers include neuronal (UCH-L1) and glial (GFAP) markers and exploratory proteomics in blood and cerebrospinal fluid collected prior to stimulation and at discharge.DiscussionThe STEP-RAISE trial evaluates safety and preliminary efficacy of non-invasive tSCS initiated within 72 h of SCI to improve sensorimotor recovery. Neurophysiological and patient-reported outcomes will characterize recovery and assess whether early tSCS augments functional recovery. This study is designed to estimate treatment effects and inform subsequent trials in acute SCI. Planned enrollment includes 5 participants in Phase 1 and 10 in Phase 2.Clinical trial registrationClinicalTrial.gov: NCT07090473; first posted on 07/29/2025, first open to enrollment 04/2026. https://clinicaltrials.gov/study/NCT07090473

Using cortical auditory-evoked potential responses to verify the objective benefit of aural rehabilitation in adult cochlear implant users

IntroductionCortical auditory-evoked potential (CAEP) responses are used clinically to assess auditory processing and support cochlear implant (CI) mapping procedures post-implantation. This study aims to examine CAEP responses as an objective measure of neurophysiological changes following a structured Aural Rehabilitation Program (ARP) in long-term adult CI users, with poor baseline speech perception performance. Advancing our understanding of the mechanisms underlying improved post-implantation outcomes in poor performing CI users may inform the development of targeted interventions and refinement of evidence-based rehabilitation strategies.MethodsAdult unilateral CI users with post-lingual deafness were recruited for an intensive clinician-directed ARP incorporating structured active listening exercises. The ARP consisted of weekly 1-h face-to-face sessions over 10 weeks with repeated assessments at baseline (T0) and 10-week intervals (T10, T20, T30). Participants were allocated to immediate (Group 1), 10-week delay (Group 2), or 20-week delay (Group 3) ARP groups, while a control group completed assessments without intensive ARP. Speech perception in quiet [CNC phoneme and word scores (%)] and electrically-evoked CAEP (eCAEP) response [P1-N1-P2 peak latencies (ms) and amplitudes (μV)] measures were collected at each time point for all groups. The repeated measures design incorporated staggered pre- and post-ARP periods for Groups 1–3 (T0-T10, T10-T20, and T20-T30, respectively). CNC and eCAEP measures were analyzed pre- and post-ARP intervention and across assessment intervals (T0-T30) to evaluate rehabilitation effects and account for natural variability and potential ongoing adaptation in auditory performance over time, independent of ARP-related changes.ResultsNo significant changes were observed in eCAEP response latencies or amplitudes from pre- to post-rehabilitation. However, the ARP intervention group demonstrated significantly higher CNC phoneme and word recognition scores compared to the control group in both implant-alone and binaural listening conditions post-rehabilitation.DiscussionNo measurable neurophysiological changes were observed in eCAEP responses from pre- to post-rehabilitation. However, the ARP intervention group demonstrated behavioral improvements, reflected in marginal increases in speech perception scores at both phoneme and word recognition levels, which were not observed in the control group. These findings highlight the clinical value of structured aural rehabilitation in supporting improved outcomes for long-term adult CI users with poor baseline performance.

Mechanisms underlying the association between perceived recurrence risk and negative emotions in patients with ischemic stroke: a cross-sectional study

ObjectiveTo examine the relationships among perceived risk of recurrence, attitudes toward seeking professional psychological help, negative emotions, and family care in patients with ischemic stroke, and to test a moderated mediation model. The findings aim to provide a scientific basis for optimizing clinical psychological interventions and family support strategies.MethodsA cross-sectional survey was conducted among 311 patients with ischemic stroke recruited from three tertiary hospitals in Sichuan Province, China. Data were collected using validated scales measuring perceived recurrence risk, help-seeking attitudes, negative emotions, and family care. Mediation and moderated mediation analyses were performed using SPSS 27.0 and PROCESS macro (Models 4 and 58), with 5, 000 bootstrap resamples to estimate 95% confidence intervals (CIs).ResultsPerceived recurrence risk was positively associated with negative emotions (β = 0.350, p < 0.001). Attitudes toward seeking professional psychological help partially mediated this association, with a significant indirect effect (effect = 0.131, 95% CI: 0.082–0.192), accounting for 40.68% of the total effect. Family care moderated both paths of the mediation model. In the first stage, family care moderated the association between perceived recurrence risk and help-seeking attitudes (β = 0.043, p = 0.001), such that higher family care weakened the negative association. In the second stage, family care moderated the association between help-seeking attitudes and negative emotions (β = −0.075, p = 0.008), indicating that higher family care strengthened the protective association between help-seeking attitudes and lower negative emotions.ConclusionPerceived recurrence risk, help-seeking attitudes, and negative emotions are significantly associated in patients with ischemic stroke. Help-seeking attitudes partially explain this association, while family care plays a significant moderating role in both stages. These findings highlight the importance of psychological and family-centered support in stroke rehabilitation. However, causal interpretations should be made cautiously due to the cross-sectional design.

The association between worry, rumination, and metacognitive beliefs in female adolescents with Anorexia Nervosa

BackgroundA growing body of literature has emphasized the role of worry and rumination in eating disorders (EDs). According to the metacognitive model, worry and rumination are maintained by dysfunctional metacognitive beliefs. Although metacognitive beliefs have been investigated in adults with EDs, their role in adolescents with EDs remains underexplored. The present exploratory study aimed to examine the specific association among worry, rumination, and metacognitive beliefs and eating disorder symptomatology in adolescents with AN.MethodsThirty Italian female adolescents (mean age ± SD: 15.387 ± 1.35 years, mean Body Mass Index (BMI): 16.34 ± 2.5 kg/m2) completed a self-report survey composed of the Penn State Worry Questionnaire (PSWQ), the Ruminative Response Scale (RRS), the Metacognitions Questionnaire – 30 (MCQ-30), and the Eating Disorder Inventory – 3 (EDI-3).ResultsThus, Model 1, including RRS and PSWQ, was significant (F = 17.5, p<0.001) and explained 57% of the variance (R² = 0.574). Within this model, RRS was the only significant predictor (p = 0.019) of the Eating Disorder Risk Composite (EDRC) of EDI-3, indicating that higher rumination scores were associated with greater eating disorder symptomatology. Once MCQ was entered as a predictor of EDRC, there was no significant incremental variance compared with Model 2 (ΔR² = 0.0034, p = 0.658), even though the model remained significant overall (F = 11.4, p < 0.001). The final model explained 58% of variance (R² = 0.578; Cohen’s f2 = 1.37).ConclusionRumination was significantly associated with eating disorder symptomatology. Although worry showed strong positive associations with eating disorder symptomatology at the correlational level, it did not maintain an independent role once rumination was included in the regression model. The final model showed a very large effect size (Cohen’s f² = 1.37), suggesting strong associations between predictors and eating disorder symptoms in the present sample. However, this estimate should be interpreted cautiously, given the limited sample size and the exploratory nature of the analysis. Contrary to our expectations, metacognitive beliefs did not significantly explain the variance of eating disorder symptomatology. This finding may reflect the more proximal role of RNT in explaining the variance in eating disorder symptomatology, or alternatively, the possibility that only specific metacognitive domains—rather than overall metacognitive functioning—are relevant in this population.

Engitix Licenses Lonza’s Technology to Advance ADC Therapies

Lonza and Engitix signed a licensing agreement to advance the development of antibody-drug conjugates (ADCs) as therapies for patients with chronic diseases.

Engitix will access Lonza’s ADC technology platform through a single-target license, including the use of SYNtecan E™ linker-payload and complementary GlycoConnect® and HydraSpace®. These technologies are intended to support Engitix’s goal to develop and commercialize therapies.

Lonza, through one of its affiliated companies, is eligible to receive upfront, clinical, regulatory, and commercial milestone payments, plus royalties on net sales of resulting products. Lonza is responsible for manufacturing components that are related to its proprietary technologies, and Engitix will work on the R&D, manufacturing, and commercialization of the ADCs.

Engitix has developed a proprietary human extracellular matrix (ECM) platform that allows the study of disease biology directly in human tissue, according to a company official, who adds that this approach focuses on targets within the ECM itself, offering a differentiated pathway compared to traditional methods that focus on cell surface targets. 

The collaboration enables Engitix to leverage Lonza’s established ADC technology platform to develop differentiated therapeutic candidates designed to selectively deliver potent payloads to tumor-selective targets identified through Engitix’s proprietary human ECM discovery platform, explains Giuseppe Mazza, MD, PhD, CEO and co-founder of Engitix.

‘We are committed to translating our unique understanding of the disease microenvironment into transformative therapies for patients with high unmet medical need,” he continues. “Licensing Lonza’s clinically validated conjugation and linker-payload technologies provides us with a powerful toolkit to develop next-generation ECM-targeted therapeutics with the potential for enhanced efficacy, reduced toxicity and improved therapeutic index.” 

“We are pleased to collaborate with Engitix on this innovative program,” says Jan Vertommen, vice president of commercial development, advanced synthesis, Lonza. “By combining our ADC development and  manufacturing expertise with Engitix’s unique ECM-based discovery platform, we aim to advance next-generation ADCs and unlock new possibilities in targeted therapies for patients.” 

The post Engitix Licenses Lonza’s Technology to Advance ADC Therapies appeared first on GEN – Genetic Engineering and Biotechnology News.

Job dissatisfaction and health care access uncertainty grows in the U.S., new study finds

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Good morning. I admit that I didn’t finish rereading “The Odyssey” before I saw the movie last weekend, but it’s never too late. For now, scroll down to read a related First Opinion essay and to sign up for office hours with Bob Herman, STAT’s own Homeric chronicler of the business of health care.

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Shape-shifting mirrors on NASA’s new space telescope could unveil Jupiters like our own

When NASA’s Nancy Grace Roman Space Telescope launches, as early as the end of next month, it will attempt one of astronomy’s most precise disappearing acts to date. The telescope will carry the first space-bound “active” coronagraph, an instrument that effectively erases most of the light from a star during photography.

It will allow astronomers to take the first pictures of planets orbiting other stars that are similar to those in our solar system. Ultimately, it could pave the way for a future mission that could snap the first photos of Earth-like worlds.

“I hope it’s remembered for it being that critical stepping stone for … finding Earth 2.0,” says Brandon Creager, the instrument’s lead mechanical engineer at NASA’s Jet Propulsion Laboratory (JPL).

Named after Nancy Grace Roman, NASA’s first chief of astronomy, this new telescope will carry a roughly 300-megapixel wide-field camera that will enable it to capture images about 100 times larger than the Hubble Space Telescope’s widest exposures at a similar resolution.

These capabilities will help astronomers unpack the mysterious identities of dark matter and dark energy—and to detect around 100,000 new exoplanets, planets outside our solar system, whose presence can be inferred from the way they distort the starlight of more distant stars. Javier Viaña, a research scientist at Harvard who has had two projects selected for Roman’s highly competitive first year of observing, compares the leap to moving from “interviewing a handful of people” to “conducting a global census.”

Another camera will use the coronagraph, blocking out a star’s light as it observes one stellar system at a time. The instrument will allow astronomers an unprecedented look at the space around stars, enabling them to see smaller, dimmer, and more close-in exoplanets. “It’s giving us the ability to see planets that we haven’t been able to physically see before,” says Creager.

The anatomy of a vanishing trick

Coronagraphs in space aren’t new. But earlier incarnations, such as those currently aboard Hubble and the James Webb Space Telescope, use a stationary system to block a star’s blinding light. The approach does help, but it’s a bit like putting your thumb over a flashlight while searching a dark room for a firefly. Though the bulb vanishes, stray glare can still escape and overwhelm the light of the insect. Inside a telescope, that glare can come from light leaking around the edges of machinery or from minuscule imperfections in mirrors and coatings that can scatter starlight into speckles. All this can hide, or even impersonate, a planet.

Roman’s coronagraph, however, will attempt something completely unseen in space telescopes until this year: Before each observation, it will measure that leftover light and try to suppress it, a technique known as active wavefront control.

The telescope is able to do this because it contains two deformable mirrors. Each has a 48-by-48 checkerboard of actuators (tiny pistons) beneath a thin, deformable sheet of glass. Applying a small amount of voltage makes the actuators contract and tug their patches of mirror slightly backward, like thousands of microscopic fingers delicately sculpting a surface.

The effect is very subtle: Each patch of mirror can deform by up to 0.5 micrometers, or about one-fourth the size of an E. coli bacterium, and in increments as small as approximately 10 picometers. That’s about a tenth the diameter of a hydrogen atom, says Ilya Poberezhskiy, the instrument’s project systems engineer at JPL.

The actuators allow the mirrors to create an “active wavefront,” where each component is moved to the perfect position to cancel out incoming waves of unwanted light—a bit like a pair of noise-canceling headphones, but for light instead of sound. The “canceled-out” light creates a “doughnut-shaped region around the star where we suppress starlight and where we’re hoping to see exoplanets,” says Poberezhskiy.

Compared with current space-based coronagraphs, the system is expected to improve sensitivity to exoplanets against the glare of their host stars by a factor of up to 1,000, revealing planets that would have been far too faint to detect before.

Like Hubble and JWST, Roman also uses masks, patterned plates placed in the path of the light that are designed to block the photons that run into them. One tool in Roman’s mask arsenal is “silicon grass,” a thicket of microscopic spikes on some masks that can be used in certain configurations to absorb photons so they don’t bounce around the telescope and accidentally reach a detector.

Light entering the forest bounces deeper and deeper between the blades and gets trapped instead of reflecting back toward the camera. “Once the light gets into there, it never gets out,” Poberezhskiy says. The mirrors and masks form a succession of gates and hedges to guide as much of the preserved planetary light as possible toward the final detector.

Alien Jupiters

This elaborate setup could open a new chapter in the direct imaging of exoplanets. Nearly all exoplanets photographed so far are oversize youngsters that are nothing like the residents of our solar system: several times the mass of Jupiter, still glowing with the heat left over from their birth, and orbiting tens or hundreds of times farther from their star than the Earth is from the sun. This is because they are relatively easy to see. Their size, warmth, and distance from their parent star makes them shine brightly in infrared light, far away from the worst of the stellar glare.

Roman, however, could directly image a true Jupiter analogue—a planet similar to Jupiter in mass and circling a sunlike star a few times farther out than Earth is from our sun. Unlike the hot Jupiters we can see now, this one would be a much more mature gas giant like ours, primarily reflecting its parent star’s light after billions of years of cooling instead of heavily emitting its own.

Astronomers have been able to infer the existence of such planets from the gravitational wobble they impart to the star. Roman instead will collect starlight reflected from the planet itself. “We’re not looking at the star. We’re not looking at the effect of the planet on the star,” says Meredith MacGregor, a professor of astronomy at Johns Hopkins who has also secured an observing program. “We are actually looking at the planet, and that is super powerful.”

Once this instrument becomes available, it will become the scientists’ turn to do their jobs. “I’m honestly a little terrified about how we’re all going to deal with it, because I think it’s just so much data,” MacGregor says. “I think people will legitimately still be working on Roman data for decades.”

But don’t expect to see a 4K photo of an alien Jupiter in the coming months. Roman will not be able to resolve such a planet into a solid globe—at best, it will likely resemble a smattering of pixels. Still, that will be enough, MacGregor says, as Roman can then use the coronagraph to get information on the various wavelengths of light from the planet, which can tell astronomers about its atmospheric chemistry.

“You’re taking something that’s a point of light and turning it into an actual world,” she says, “because if you know that about its atmosphere, now you know something about the surface of the planet and the possibility of life being on that planet, right? So that’s a big step.”

During its first observations, scientists and engineers will see whether they can hold a star at the very center of the coronagraph’s masks, shape the mirrors, “dig” the dark doughnut (as Poberezhskiy describes it), and then maintain everything as the spacecraft moves through space and actively changes temperature.

The results will inform NASA’s proposed Habitable Worlds Observatory, the daydream of many an exoplanet astronomer, which will in theory be able to separate the light of an Earthlike planet from that of a sunlike star, over 10 billion times brighter.

Creager, who has worked on the instrument since 2018, is proud of the achievement: “Not too many people get to say, ‘I built something and it’s taking a picture of a planet that’s at a star that’s 50 light-years away or 100 light-years away.’” He imagines the moment he and his team will be able to look at the first image as it arrives: “Yes, we did that.” While the planet may show up only as a tiny dot, Roman’s achievement will be the darkness engineered around it.

Opinion: STAT+: I’m a cardiologist. I’m not sure the new cholesterol drug enlicitide is a game-changer

A long-awaited moment in preventive cardiology arrived last week, when enlicitide (which Merck is selling under the name Lipfendra) was approved by the FDA to lower blood cholesterol levels.

As the first oral PCSK9 inhibitor — powerful cholesterol-lowering medications, that, until now, have only been injectable — enlicitide itself is an impressive achievement. It punctuates a story of pharmaceutical innovation that has glided from the stories of families enrolled in the Dallas Heart Study at the bedside, to drug targets discovered at the lab bench, all ultimately transforming care back at the bedside.

It also comes at an opportune time. With new clinical guidelines supporting a more aggressive approach to lowering cholesterol levels, enlicitide may be particularly useful for people with either established or at high risk for cardiovascular disease. For the millions of Americans who fit into these groups, it has already been hailed as a game changer. But the story here — of whom it would actually help, and what it implies about prevention today — is more complicated.

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STAT+: Federal health quality research grants worth $109 million ended early

Dozens of researchers funded by the federal Agency for Healthcare Research and Quality received notices last week that they would not receive future installments of funding for their ongoing research grants. While frustrating, the development was largely not a surprise to these researchers, many of whom had been waiting months for renewed funding or been unable to get explanations as to why the funding spigots had run dry from staffers at the agency. 

The notices punctuated nearly a year of uncertainty for health services researchers funded by AHRQ and left those who lost funding concerned about the future of their field. AcademyHealth, a professional organization representing health services researchers, has confirmed at least 78 grants worth $200 million have been affected. In all, those grants had $109.2 million in funding remaining, it  estimated.

Grant recipients were told in a letter of “non-award” that “AHRQ is adjusting its discretionary health services research award portfolio in order to better prioritize agency resources towards the above-mentioned priorities to best serve the interests of the Federal Government,” according to one such letter reviewed by STAT. The letter states the agency is prioritizing research on patient safety, antibiotic resistance, AI, long Covid, nutrition, and understanding autism, among others. 

Continue to STAT+ to read the full story…