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Automated thermo-mechanical therapy for immediate relief in chronic non-specific lower back pain: a randomized controlled trial

Donnery, Kyle; Pilloni, Giuseppina; FallahRad, Mohamad; Lee, Kiwon; Han, Byungyun; Park, Soonhi; Kim, Jihye; Charvet, Leigh; Bikson, Marom
OBJECTIVE/UNASSIGNED:Chronic non-specific lower back pain (cNSLBP) is a prevalent and disabling condition, imposing a substantial socioeconomic burden due to high healthcare costs and productivity losses, with limited accessible and effective long-term treatment options. Automated Thermo-mechanical Therapy (ATT) is a promising, non-drug intervention that leverages innovative technical advances to provide multimodal pain relief, offering accessibility and low-cost delivery. This study tested ATT for immediate pain relief in individuals with cNSLBP in a single-session, double-blind, randomized controlled trial. METHODS/UNASSIGNED:= 20) in a 40-min session with urn randomization. The active device applied heated cylindrical rollers along the spine, using far-infrared heat and mechanical tissue stimulation tailored to spinal alignment. In the control condition, the device used minimal mechanical therapy intensity without heat, targeting only the cervical area to avoid lower back therapeutic effects. Pre- and post-intervention assessments measured changes in pain intensity (primary outcome) via a 100-mm Visual Analog Scale for Pain (VAS-P100), alongside secondary outcomes assessing pain characteristics, anxiety, and functional mobility. RESULTS/UNASSIGNED:= 0.0031). No adverse events were reported, and all participants tolerated the intervention well. CONCLUSIONS/UNASSIGNED:A single session of ATT provides immediate, significant pain relief in individuals with cNSLBP, supporting its potential as a safe, non-invasive option for managing chronic back pain. Future studies should examine the long-term benefits of repeated ATT sessions and explore mechanistic insights into thermo-mechanical stimulation's effects on pain and function. CLINICAL TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov, identifier: NCT06769321.
PMCID:12827622
PMID: 41585325
ISSN: 2673-6195
CID: 6003002

From abandonment to adoption: advancing assistive technologies for blindness and low vision in the AI era

Barak Ventura, Roni; Hamilton-Fletcher, Giles; Rizzo, John-Ross
Assistive technologies can enhance safety, independence, and quality of life for people with blindness and low vision. Despite their benefits, abandonment of these technologies remains widespread, and recent research on this issue is limited. In this Perspective article, we draw on both professional experiences and relevant scientific literature to examine adoption and abandonment in the context of new artificial intelligence-powered applications. We highlight risks arising from misaligned design, inconsistent industry support, and inadequate user training. We synthesize existing knowledge on factors that influence abandonment and propose three priorities to realign assistive technology development: participatory and transdisciplinary research, integrated technology ecosystems, and socially supported engagement. Taken collectively, these priorities ensure that emerging assistive technologies better align with the needs of people with blindness and low vision, promoting lasting adoption rather than abandonment.
PMCID:12832816
PMID: 41602206
ISSN: 2673-253x
CID: 6003372

Motion Tracking Analysis of Robotic Versus Hand-Sewn Sutures in End-To-Side Microanastomoses

Gutstadt, Eleanor; Wiggan, Daniel D; Grin, Eric A; Sangwon, Karl L; Sharashidze, Vera; Chung, Charlotte; Raz, Eytan; Shapiro, Maksim; Baranoski, Jacob F; Riina, Howard A; Rutledge, Caleb; Nossek, Erez
BACKGROUND AND OBJECTIVES/OBJECTIVE:Hand-sewn (HS) microsuturing is limited by tremor and fatigue. Robotic systems may improve performance, but quantitative comparisons remain limited. This study evaluates the precision of robot-assisted vs manual suturing during end-to-side microanastomosis. METHODS:Under simulation, microsurgical robot-assisted and HS sutures for end-to-side microanastomosis were performed by a single surgeon. One thousand four hundred and ninety-four total frames were assessed within 4 videos. Each robotic clip was paired with a corresponding HS clip. Tracker software extracted 2-dimensional positional data. Motion trajectories were smoothed using Savitzky-Golay filtering for an ideal suture trajectory. Deviation from an ideal path was quantified using Euclidean distance. Mean and SD of path deviation were calculated. Group comparisons were made as fold-change reductions and standardized effect sizes (Cohen d) to quantify the magnitude of observed differences. RESULTS:Robotic-assisted sutures demonstrated significantly lower mean path deviation and variability than HS sutures, particularly for the dominant (right) hand, with consistently large effect sizes for the right hand (all = 1.2, r = 0.5) and smaller for the left hand (d = 0.36-0.71, r = 0.18-0.33). CONCLUSION/CONCLUSIONS:Robotic microsuturing with microsurgical assistant significantly improves path fidelity, particularly in dominant-hand tasks. Manual sutures showed larger deviations between the ideal suture and raw data, supporting robotic integration into cerebrovascular neurosurgery and warranting study in live models.
PMID: 41460085
ISSN: 2332-4260
CID: 6000992

Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines (2017-2025: An update) - endorsed by the European Society for Brain Stimulation (ESBS) and by the International Federation for Clinical Neurophysiology (IFCN)

Antal, Andrea; Bjekić, Jovana; Ganho-Ávila, Ana; Alekseichuk, Ivan; Assecondi, Sara; Bergmann, Til Ole; Bikson, Marom; Brunelin, Jerome; Brunoni, Andre R; Charvet, Leigh; Chen, Robert; Cohen Kadosh, Roi; Diedrich, Lukas; D'Urso, Giordano; Ferrucci, Roberta; Filipović, Saša R; Fitzgerald, Paul B; Flöel, Agnes; Fröhlich, Flavio; George, Mark S; Hamilton, Roy H; Haueisen, Jens; Hallett, Mark; Herrmann, Christoph S; Hummel, Friedhelm C; Jaberzadeh, Shapour; Langguth, Berthold; Lavidor, Michal; Lefaucheur, Jean-Pascal; Miniussi, Carlo; Moliadze, Vera; Nikander, Mika; Nikolin, Stevan; Nitsche, Michael A; Opitz, Alexander; O'Shea, Jacinta; Padberg, Frank; Plewnia, Christian; Priori, Alberto; Ramasawmy, Perianen; Razza, Lais B; Rossi, Simone; Rothwell, John; Rueger, Maria A; Ruffini, Giulio; Sack, Alexander T; Salvador, Ricardo; Schellhorn, Klaus; Schuhmann, Teresa; Shirota, Yuichiro; Siebner, Hartwig Roman; Thielscher, Axel; Ugawa, Yoshikazu; Uusitalo, Susanne; Wexler, Anna; Paulus, Walter; Vanderhasselt, Marie-Anne; Van Waes, Vincent; Wessel, Maximilian J; Wischnewski, Miles; Baeken, Chris; Ziemann, Ulf
This guideline summarizes updated safety data (2017-2025) and provides expert recommendations on the use of low intensity transcranial electrical stimulation (tES) in humans. tES encompasses several techniques including transcranial direct current stimulation (tDCS), oscillatory transcranial direct current stimulation (otDCS), transcranial alternating current stimulation (tACS), transcranial random noise stimulation (tRNS), transcranial temporal interference stimulation (tTIS), and their combinations or variations. Across over 300,000 sessions involving healthy individuals, patients with neuropsychiatric conditions, and other clinical populations, no tES-related serious adverse events (AEs) have been reported. Moderate AEs are rare and limited to a small range of specific applications. Mild AEs are common and include transient symptoms such as localized sensations (e.g., tingling or burning), headaches, and fatigue. Similar mild AEs are also reported by individuals receiving placebo stimulation. The frequency, magnitude, and type of AEs are comparable across healthy, clinical, and vulnerable groups, including children, elderly, or pregnant women. Combined interventions (e.g., co-application with EEG, TMS, or neuroimaging) have not shown increased safety risks. Safety is well-established for both bipolar and multichannel tES when applied up to 4 mA and up to 60 min per day. Higher intensities and longer stimulation durations may also be safe. Nevertheless, the number of studies using intensities above 4 mA or stimulating longer than 60 min is low. Home-based use of treatments is growing rapidly, leveraging remote supervision to provide patients with greater access and enable repeated, sustained dosing paradigms. We recommend using screening and AE questionnaires in future controlled studies, in particular when planning to extend the stimulation parameters applied. We discuss recent regulatory and ethical issues.
PMID: 41622107
ISSN: 1872-8952
CID: 5999422

Fingolimod as a Potential Cerebroprotectant Results From the Stroke Preclinical Assessment Network

Boisserand, Ligia S B; Herman, Alison L; Sanganahalli, Basavaraju G; Mihailovic, Jelena; Beatty, Hannah E; Johnson, Conor W; Diaz, Sebastian; DeLong, Jonathan H; Velazquez, Sofia; Grutzendler, Jaime; Dela Cruz, Charles; Zhou, Jiangbing; Sheth, Kevin N; Matouk, Charles; Zhan, Shenqi; Morais, Andreia; Imai, Takahiko; Chauhan, Anjali; Patel, Rakesh B; Kumskova, Mariia; Shi, Yanrong; Avery, Brooklyn D; Lamb, Jessica; Nagarkatti, Karisma A; Khan, Mohammad B; Kamat, Pradip K; Dhandapani, Krishnan M; McCullough, Louise D; Aronowski, Jaroslaw; Hess, David; Koehler, Raymond C; Lyden, Patrick; Leira, Enrique C; Chauhan, Anil K; Ayata, Cenk; Chen, Mu-Hsun; Diniz, Marcio A; Hyder, Fahmeed; Sansing, Lauren H; ,
BACKGROUND/UNASSIGNED:Fingolimod is an immunomodulatory drug that has shown promising effects in stroke treatment, including improvements in neurofunctional recovery and a reduction in infarct size. Fingolimod modulates the sphingosine-1-phosphate receptors, which leads to the internalization of sphingosine-1-phosphate receptors on T and B lymphocytes, thereby preventing their egress from secondary lymphoid organs. Here, we report a secondary analysis from the Stroke Preclinical Assessment Network trial. We assessed the effects of fingolimod versus vehicle on stroke outcomes to better evaluate its therapeutic potential. METHODS/UNASSIGNED:The animal population (n=409) comprised male and female animals treated with fingolimod or vehicle. We used 4 clinically relevant models: young healthy mice (10-12 weeks-old), aging mice (16±1 month-old), obesity induced-hyperglycemic mice fed with a high-fat diet for 12 weeks (16 weeks-old), and spontaneously hypertensive rats (16±1 weeks-old). Stroke was induced by the middle cerebral artery occlusion for 1 hour, followed by reperfusion. Animals received a total of 6 intraperitoneal injections of 0.5 mg/kg twice daily of fingolimod or vehicle. Functional outcomes in the corner test and foot-faults test were measured at days 7 and 28. Lesion size and brain morphometry were evaluated at days 2 and 30 by magnetic resonance imaging. RESULTS/UNASSIGNED:Overall, fingolimod did not improve morphological and functional outcomes. However, fingolimod effects varied depending on sex or the comorbidity model. Fingolimod promoted a better outcome in the corner test in aging females. In contrast, it favored a worse outcome in obesity-induced hyperglycemic mice at day 7. Despite having no effect on survival rates or lesion size, fingolimod attenuated the midline retraction at day 30 in aging males, consistent with less atrophy. CONCLUSIONS/UNASSIGNED:Although fingolimod did not significantly benefit the overall primary functional outcome, its effects varied with sex and comorbidity models, underscoring how the therapeutic potential of a particular drug can differ in a heterogeneous population.
PMID: 40899256
ISSN: 1524-4628
CID: 5997752

GLP-1 Receptor Agonist in Nonobese Patients with Type 2 Diabetes Mellitus and Heart Failure with Preserved Ejection Fraction

Khadke, Sumanth; Kumar, Ashish; Bhatti, Ammar; Dani, Sourbha S; Al-Kindi, Sadeer; Nasir, Khurram; Virani, Salim S; Upadhyay, Jagriti; Garcia-Banigan, Dinamarie C; Abraham, Sonu; Husami, Raya; Kong, Yixin; Labib, Sherif; Venesy, David; Shah, Sachin; Lenihan, Daniel; Vaduganathan, Muthiah; Deswal, Anita; Fonarow, Gregg C; Butler, Javed; Nohria, Anju; Kosiborod, Mikhail N; Ganatra, Sarju
BACKGROUND:Glucagon-like peptide-1 receptor agonists (GLP-1RAs) promote weight loss and improve heart failure-related symptoms, quality of life, and functional capacity in patients with obesity and heart failure with preserved ejection fraction (HFpEF). However, their clinical effectiveness in nonobese patients with diabetes and HFpEF is understudied. METHODS:The TriNetX research network was used to identify adult patients (≥18 years) with type 2 diabetes mellitus (T2DM), heart failure with preserved ejection fraction (left ventricular ejection fraction ≥45%), elevated brain natriuretic peptide (≥ 150 pg/mL) or N-terminal pro-B-type natriuretic peptide(≥ 450 pg/mL) and a body mass index (BMI) <30 kg/m2 on or before August 31, 2022. Patients were divided into two groups based on GLP-1RA use. After propensity score matching, Cox proportional hazard ratios (HRs) were used to compare outcomes over a 12-month follow-up period. RESULTS:The study included 84,990 patients (n= 42,495 per group, mean age 64 years, 49% females, 65% white). Patients on GLP-1RAs were associated with lower incidence of heart failure exacerbation events (HR 0.60, 95% CI 0.58-0.62, p<0.001) and all-cause emergency room visits or hospitalizations (HR, 0.67, 95% CI 0.66-0.69; P < .001) compared with those not on GLP-1RAs. Other outcomes, including acute myocardial infarction, atrial fibrillation, ischemic stroke, pulmonary hypertension, C-reactive protein ≥ 5 mg/L, acute kidney injury, and the need for renal replacement therapy, were also significantly less frequent in the GLP-1RA group. These associated benefits persisted even among patients on a sodium-glucose cotransporter-2 inhibitor (SGLT2i). CONCLUSION/CONCLUSIONS:GLP-1RA use is associated with improved cardiovascular outcomes in nonobese patients with T2DM and HFpEF and has an associated incremental benefit even among patients on SGLT2i.
PMID: 39667523
ISSN: 1532-8414
CID: 5990462

Association of Palliative Care Consultation in Patients With Heart Failure With Preserved Ejection Fraction With Symptom Burden and Health Care Use

Warraich, Haider J; Godfrey, Sarah; Makwana, Bhargav; Abraham, Sonu; Aglan, Amro; Saji, Anu Mariam; Khadke, Sumanth; Patel, Rushin; Kumar, Ashish; Patel, Vahin; Parikh, Aneri; Banker, Ahan; Venesy, David; Shah, Sachin; Winzelberg, Gary S; Nohria, Anju; Dani, Sourbha S; Ganatra, Sarju
BACKGROUND/UNASSIGNED:Guidelines recommend palliative care (PC) for patients with heart failure. However, little research has been performed assessing the effect of PC consultation in patients with heart failure with preserved ejection fraction (HFpEF). OBJECTIVES/UNASSIGNED:The purpose of this study was to investigate the impact of PC consultation on symptom burden and health care utilization among individuals with HFpEF during the last 3 years of their lives. METHODS/UNASSIGNED:We retrospectively analyzed electronic medical records from 72 centers, mainly in the United States. All patients with HFpEF, identified using International Classification of Diseases codes, who died within 3 years of the diagnosis were selected and then stratified based on receipt of PC consultation. Propensity score matching was used to control for between-group differences. RESULTS/UNASSIGNED:Two hundred twenty-six thousand nine hundred twenty-one patients with HFpEF died within 3 years, only 26.4% of whom received a PC consult. In the unmatched cohort, patients who received a PC consult were more likely to be female, Black, and had more comorbidities. After propensity matching, patients receiving PC consultation were less likely to experience an emergency room visit or hospitalization (2.2% vs 4.6%), surgery or anesthesia (1.1% vs 4.2%), critical care (0.7% vs 1.9%), or receive cardiovascular procedures or tests (1.7% vs 4.7%). Furthermore, they were also less likely to have cardiorespiratory symptoms (2.5% vs 5.7%), heart failure exacerbations (1.6% vs 3.3%), cognitive symptoms (1.7% vs 3.4%), falls (0.3% vs 0.6%), and depression or anxiety (1.3% vs 2.8%). CONCLUSIONS/UNASSIGNED:PC consultation is associated with reduced potential unwanted health care utilization and improvement in symptoms in patients with HFpEF in their last 3 years of life. However, PC continues to be underused in this population.
PMCID:11653141
PMID: 39697769
ISSN: 2772-963x
CID: 5990472

Advancing early and equitable detection of dementia: key learnings/challenges, recent innovations, and future directions

Chodosh, Joshua; Borson, Soo; Nordyke, Alexandra; Kwon, Simona C; Marsh, Karyn; Vedvyas, Alok; Lee, Matthew
Worldwide, over half of all individuals with dementia are undiagnosed. In the United States, racial, ethnic, and economic inequities mirror global findings, with higher rates of missed and delayed diagnosis and poorer diagnostic quality among minoritized and disadvantaged groups. For example, delayed diagnosis is more prevalent among people identifying as non-Hispanic Black or Latino than non-Hispanic White. Systematic efforts to improve detection can increase diagnosis rates; there is broad consensus that earlier detection and initiation of focused care and support services benefit both affected individuals and their loved ones. Systemic under-detection and its contributions to persistent population-level suffering underscore the importance of early detection of dementia as a key public health issue. Improving early detection calls for comprehensive, coordinated responses from local, regional, and national public health systems in partnership with health care delivery systems and community-based organizations. The Public Health Center of Excellence on Early Detection of Dementia (PHCOE on EDD), funded by the Centers for Disease Control and Prevention (CDC), is a national resource to promote understanding and implementation of evidence-based and evidence-informed public health strategy for early detection of dementia. We, together with the PHCOEs on Dementia Risk Reduction and Dementia Caregiving, and nearly four dozen state and local initiatives, seek to operationalize the priorities of the Building Our Largest Dementia Infrastructure for Alzheimer's Act and National Healthy Brain Initiative, established by federal legislation in 2018 and 2024. Our efforts support the CDC's mandate to build a national public health infrastructure for brain health and dementia.
PMCID:12736990
PMID: 41032250
ISSN: 1758-5341
CID: 5986962

Perioperative Resuscitation and Life Support (PeRLS): An Update

Moitra, Vivek K; Banerjee, Arna; Ben-Jacob, Talia K; Cortegiani, Andrea; Einav, Sharon; Gitman, Marina; Ippolito, Mariachiara; Klock, P Allan; Lakbar, Inès; Maccioli, Gerald; McEvoy, Matthew D; Mueller, Dorothee; Shander, Aryeh; Sreedharan, Roshni; Stahl, David L; Tong, Jeffrey; Weinberg, Guy; Williams, George; O'Connor, Michael F; Nunnally, Mark E
Cardiovascular collapse and arrest in the periprocedural setting and intensive care unit differ from arrests in other contexts (such as out-of-hospital or hospital ward) because clinicians almost always witness the event, and the most likely precipitating cause may be known. In comparison to other settings, the response can be timelier and more focused on treating the underlying cause(s). Since many patients deteriorate over minutes to hours, clinicians can evaluate the patient expeditiously, generate a diagnosis, and initiate appropriate treatment more rapidly than in other arrest circumstances. This iteration of Perioperative Resuscitation and Life Support (PeRLS) employs Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) methodology to review the most recent evidence on preventing and managing cardiac arrest during the perioperative period. Furthermore, many of the recommendations and algorithms may also be applicable to areas outside the operating room, such as the intensive care unit and emergency room.
PMID: 41537508
ISSN: 1528-1175
CID: 5986502

Biomarkers

Miner, Annalise E; Ashton, Nicholas J; Zetterberg, Henrik; Blennow, Kaj; Groh, Jenna R; Tripodis, Yorghos; Adler, Charles; Balcer, Laura; Bernick, Charles B; Peskind, Elaine R; Asken, Breton M; Tanner, Jeremy A; Rabinovici, Gil D; Banks, Sarah J; Barr, William B; Wethe, Jennifer V; Cantu, Robert C; Dodick, David W; Mez, Jesse; Palmisano, Joseph N; Martin, Brett; Stein, Thor D; McKee, Ann C; Cummings, Jeffrey L; Shenton, Martha E; Reiman, Eric M; Stern, Robert A; Alosco, Michael L
BACKGROUND:In vivo biomarkers that can detect long-term neuropathologies from repetitive head impact (RHI) exposure are needed, especially for the neurodegenerative tauopathy chronic traumatic encephalopathy (CTE). Here, we evaluated plasma p-tau217 as a potential biomarker for CTE p-tau pathology, and examined the concordance between plasma p-tau217 and Aβ pathology in an at-risk for CTE sample. METHOD/METHODS:The sample included 180 male former football players (120 professional, 60 college), and 56 asymptomatic men without RHI (i.e., controls). Participants completed blood draws, 18F-florbetapir (Aβ+=SUVR≥1.10), and 18F-flortaucipir PET. Traumatic encephalopathy syndrome (TES) diagnoses were made. Single molecule array for plasma p-tau217 (ALZpath) was performed (≥0.6 cutoff used to maximize sensitivity). Nine participants had post-mortem tissue. ANCOVA examined group differences in p-tau217 (football vs controls; TES-CTE no, TES-CTE suggestive, TES-CTE possible/probable). Multivariable regression models tested associations between p-tau217 and florbetapir/flortaucipir PET. Covariates included age, race and APOE e4. RESULT/RESULTS:Sample characteristics are in Table 1. p-tau217 concentrations were higher in former football players compared to controls (est. marginal mean difference=-0.217, p = 0.005). There were no group differences in Aβ-PET SUVR. No differences were found across TES-CTE certainty levels. In football players, higher p-tau217 was associated with higher Aβ-PET SUVR (B=1.380, 95%CI[0.597-2.155], p = 0.001) but not when Aβ+ (n = 17) participants and those with kidney/liver disease (n = 5) were excluded. Aβ+ participants had the highest p-tau217 (Figure 1). When compared against Aβ-PET, several false Aβ-positives (high p-tau217, Aβ-) were identified, including one extreme outlier (assay related) and a cluster of Aβ- participants with p-tau217 between 0.60-1.0. There were no associations with flortaucipir SUVR (frontal, mesial temporal, left parietal). Two extreme p-tau217 outliers had autopsy-confirmed CTE stage III (AD-, Table 2). Of the remaining donors, all were AD- and four had CTE (stages II-IV) with ptau217 between 0.125-0.449. CONCLUSION/CONCLUSIONS:Plasma p-tau217 has usefulness in quantifying Aβ pathology but restricted utility for detection of CTE. In this at-risk for CTE sample, p-tau217 and Aβ-PET were associated at the group level. At the individual level, false Aβ-positives (and negatives) existed, including Aβ- participants with high p-tau217. We will explore whether this discrepancy is due to disease or peripheral interference with the N-terminal binding in p-tau assays.
PMCID:12789185
PMID: 41514488
ISSN: 1552-5279
CID: 5981492