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A Phase-2 Open-Label Trial of Cannabidiol to Treat Core and Associated Symptoms of Autism in Children and Adolescents Without Intellectual Disability

Lawson, Jacqueline; Robinson, Lauren; Conlon, Greta R; Shalev, Rebecca A; Cervantes, Paige E; Yoncheva, Yuliya; Hirsch, Glenn S; Troxel, Andrea B; Friedman, Daniel; Devinsky, Orrin; Castellanos, Francisco Xavier
OBJECTIVE:To evaluate cannabidiol (CBD) in pediatric patients with autism spectrum disorder (ASD), fluent verbal language and an estimated full-scale IQ of 80 or above. BACKGROUND:Preliminary evidence suggests CBD may ameliorate challenges associated with ASD. Whether CBD benefits pediatric ASD without accompanying intellectual or language impairment remains unknown. METHODS:, 100 mg/mL) at 3, 6, or 9 mg/kg/day using a Bayesian optimal interval dosing design. The primary endpoint was the CBD dose associated with the highest response rate (i.e., Clinical Global Impression Scale-Improvement [CGI-I] score = 1 or 2) on a target symptom domain designated individually based on informant report, standardized scales, and clinical observation. Secondary endpoints were effect sizes of changes from baseline in measures assessing ASD core and associated symptoms, and global functioning. Adverse events (AEs) were assessed weekly. Plasma CBD levels and clinical labs were obtained at the final visit. RESULTS:= 1.36, 95% CI [0.78-1.93]).Of 222 reported AEs, 27 unique AEs were considered treatment-related. Most AEs (93%) were mild and expected (82%); none was severe. The most frequent related AEs were increased salivation (30%), increased sleep duration (39%), sleepiness/sedation (26%), increased dream activity (35%), and polyuria (22%). Vital signs, physical exams, weight, liver function tests, and complete blood counts were unaffected. CBD plasma levels did not correlate with response. CONCLUSIONS:In this preliminary study, CBD was well tolerated; AEs were mild-moderate. Mean SRS2-T and subscores decreased significantly with large effect sizes, shifting from the severe to the moderate range. CLINICAL TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov Identifier NCT03900923.
PMID: 42204954
ISSN: 1557-8992
CID: 6055082

Accelerating responsibly: From novelty to necessity in visual assistive technology [Editorial]

Kempapidis, Theofilos; Manduchi, Roberto; Rizzo, John-Ross
PMID: 42334271
ISSN: 1949-3614
CID: 6055542

College students' migraine perceptions and lived experiences: A qualitative study

Minen, Mia T; Dorf, Julia; Novo, Sara; Gima, David; Nasker, Shreya; Getz, Mara
OBJECTIVE:Our objectives were to understand migraine-related perceptions among college students and the lived experiences of those with migraine on college campuses and to generate recommendations for supporting college students with migraine. BACKGROUND:During young adulthood, there is a sharp growth in migraine prevalence and disability-adjusted life years. Migraine prevalence is approximately 16% among university students and negatively influences several aspects of a student's college experience. METHODS:This was a qualitative study using phenomenological inquiry via virtual semistructured focus groups. Recruitment took place between April 2025 and July 2025. An initial 60-min focus group was conducted in May 2025 with an all-women's college to assess our questions' relevance and comprehensiveness. We then conducted four national focus groups in June 2025 and July 2025 with college students from across the United States. All focus groups included students with and without severe headache or migraine (self-reported). Focus groups were transcribed and independently coded twice. We developed themes for the five focus groups using content analysis. Qualitative analysis was conducted between July 2025 and September 2025. RESULTS:Three students attended the all-women's college focus group and 47 students attended one of the four national focus groups (n = 50). The following themes emerged from the five focus groups: (1) Migraine is often misunderstood and not discussed on campus, with misconceptions surrounding severity and its distinction from headache. (2) The impact of migraine on campus is significant, with students reporting various triggering environments, difficulty maintaining focus, attending class, performing academically, preserving social relationships, and participating in extracurricular activities. (3) The most commonly reported accommodations for migraine were academic, specifically exam- and attendance-related, though not always honored by professors. (4) Access to migraine care for students is challenging, with reports that student health centers are typically unapproachable, inconvenient, and unhelpful, with students seeking external providers for migraine. Students recommended more awareness and education initiatives for improved understanding of migraine as well as increased access to migraine resources and accommodations. CONCLUSION/CONCLUSIONS:The experiences captured in our study provide unique qualitative insights by highlighting how misunderstanding of migraine on campus contributes to social and academic challenges faced by students with migraine. Students described unmet needs related to widespread misunderstanding of migraine, limited academic flexibility, environmental triggers, limited access to care, and inconsistent implementation of accommodations, highlighting that greater awareness of migraine, especially by professors and student health services, is crucial on college campuses. There are opportunities for migraine education programs on college campuses to increase knowledge and awareness about migraine and create a more supportive migraine environment.
PMID: 42333916
ISSN: 1526-4610
CID: 6055512

Contextual variability in under-diagnosed cardiometabolic disease and cognitive vulnerability among populations at high risk for Alzheimer's disease and related dementias

Jiakponnah, Nwanyieze Ngozi; Curran, Joseph; Watermeyer, Tamlyn; Shah, Jasmit; Musili, Litha; Onyango, Stanley; Aliwa, Benard; Mackelfresh, Andy; Bubu, Omonigho Michael; Onyike, Chiadi; Okonkwo, Ozioma; Merali, Zul; Akinyemi, Rufus; Hughes, Timothy; Saleh, Mansoor; Petersen, Melissa; Blackmon, Karen; Ogunniyi, Adesola; Hendrie, Hugh; Udeh-Momoh, Chinedu
Underdiagnosis of cardiometabolic risk factors (CMRFs) may represent an unrecognised biological pathway contributing to dementia risk; yet remains poorly characterised in African and African diaspora populations. We quantified the prevalence and determinants of underdiagnosed hypertension and abnormal glycaemia across four cohorts comprising up to 7000 adults aged ≥40 years from Nigeria, Kenya, and The United States: Indianapolis, and North Texas. Underdiagnosis was defined as absence of self-reported diagnosis despite elevated systolic blood pressure ( ≥130 mmHg) or fasting blood glucose ( ≥100 mg/dL). Cohort-stratified analyses examined demographic, socioeconomic, cognitive, Alzheimer's genetic, and blood-based biomarker correlates. Underdiagnosis was pervasive in African cohorts. Elevated fasting glucose was associated with cognitive impairment in Kenya and North Texas, while severe hypertension and diabetes were linked to Alzheimer's disease-related biomarkers [pTau217/181, NFL and Aβ42/40] in North Texas (all p ≤ 0.05). These findings identify context-specific diagnostic gaps in populations at high dementia risk and highlight cardiometabolic detection as a mechanistic target for prevention.
PMID: 42327424
ISSN: 3005-1940
CID: 6055212

Sustained Reduction in Cardiopulmonary Fitness in Long COVID: A Report from the RECOVER-adult Cohort Study

Vogel, Julia Moore; Jenkins, Trevor; Cerda, Marta; Chen, Hillary; Goldman, Jason; Katz, Stuart D; Patterson, Thomas F; Ashktorab, Hassan; Bartram, Logan; Barua, Souptik; Brim, Hassan; Brown, Jeanette P; Castro, Mario; Chaibub Neto, Elias; Chestek, David; Durstenfeld, Matthew S; Erlandson, Kristine M; Flaherman, Valerie; Foulkes, Andrea S; Ghamloush, Maher; Haddad, Francois; Hadlock, Jennifer; Heath, James R; Hornikel, Bjoern; Karlson, Elizabeth W; Kaufman, Elizabeth S; Kellogg, Dean L; Levitan, Emily B; Levy, Bruce D; Martin, Jeff; McComsey, Grace A; Metz, Torri D; Motl, Robert W; Moukabary, Talal; Mullington, Janet M; Ofotokun, Igho; Okumura, Megumi J; Parthasarathy, Sairam; Plunkett, Beth A; Reeves, W Brian; Rischard, Franz; Rizzo, JohnRoss; Scott, Jake A; Sherif, Zaki A; Thaweethai, Tanayott; Trinity, Joel D; Tummalacherla, Meghasyam; Urdaneta, Alfredo E; Vasey, Andrew J; Villanueva, Daphne-Dominique; Walker, Tiffany A; Wiley, Zanthia; Sieberts, Solveig K; Krishnan, Jerry A; ,
BACKGROUND:Long-term effect of COVID-19 (Long COVID) may persist for months or years after SARS-CoV-2 infection, but longer-term cardiopulmonary manifestations have not been previously reported. OBJECTIVES/OBJECTIVE:The objective of the study was to characterize cardiopulmonary function after SARS-CoV-2 infection in a digital health substudy of the nationwide Researching COVID-19 to Enhance Recovery Adult Cohort Study. METHODS:Associations between wearable sensor device measures of cardiopulmonary fitness and survey-derived Long COVID symptoms were estimated over a 6-month window at least 6 months after infection using linear regression models adjusted for wear time, age, sex, race/ethnicity, and body mass index. RESULTS:Among 1,475 participants (72% female, 65% non-Hispanic White) a median of 21 months (IQR: 15-31 months) after infection, 498 (34%) had high symptom burden as characterized by the Researching COVID-19 to Enhance Recovery Long COVID Research Index (LCRI). High LCRI (vs low LCRI) was associated with significantly lower heart rate variability (-4.4 ms; 95% CI: -6.5 to -2.4; P < 0.001), higher resting heart rate (+1.5 beats/min [+0.7 to +2.4]; P < 0.001), fewer metabolic equivalent of task minutes (-96.3 [-128.8 to -63.8]; P < 0.001), lower step counts (-1,624 steps/day [-1,952 to -1,296]; P < 0.001), and lower activity levels (-7.9 minutes/day very or fairly active [-10.9 to -5.0]; P < 0.001). Hierarchal clustering analysis identified two subphenotypes with abnormal cardiovascular measures associated with low quality of life scores. CONCLUSIONS:Long COVID is associated with worse cardiovascular fitness. Additional studies are needed to determine if Long COVID is a novel risk factor for incident cardiovascular disease.
PMID: 42330737
ISSN: 2772-963x
CID: 6055372

Corrigendum to 'Role of CD40 in prion disease and the immune response to recombinant PrP' [Journal of Neuroimmunology 257 (2013) 21-27/475655]

Rubenstein, Richard; Chiu, Allen; Chang, Binggong; Wisniewski, Thomas
PMID: 42336695
ISSN: 1872-8421
CID: 6055622

Bridging the diagnostic gap: Expanding dementia care navigation for timely diagnosis

Carriere, Lucille; Minyo, Morgan; Bass, David; Possin, Katherine L; Samper-Ternent, Rafael; Salinas, Joel; Deaner, Nicole
Over half of dementia cases remain undiagnosed, with persistent disparities across racial, ethnic, and socioeconomic groups. Dementia care navigation (DCN) has demonstrated value in post-diagnosis settings. If implemented earlier, DCN could address diagnostic delays and care gaps. We define the diagnostic window as the period from initial symptom awareness through diagnosis and early care planning. Drawing on deliberations from the Alzheimer's Association Dementia Care Navigation Roundtable, we present a pre-diagnosis DCN framework organized across six domains and describe navigator roles across three phases: pre-evaluation, diagnostic assessment, and immediate post-diagnosis and transition. We address special considerations, including people without a care partner and those with unmet care needs. The framework complements federal initiatives such as the Guiding an Improved Dementia Experience (GUIDE) Model and the National Alzheimer's Project Act and identifies existing reimbursement pathways for pre-diagnostic navigation activities. Generating evidence to refine these models across diverse settings will be essential to inform policy action and system-level integration.
PMCID:13284736
PMID: 42324989
ISSN: 1552-5279
CID: 6055152

Position Statement on Noninvasive Seizure Detection/Alerting Devices: A Joint Statement of the American Epilepsy Society, the Epilepsy Foundation, and the Danny Did Foundation

Grzeskowiak, Caitlin; Alick-Lindstrom, Sasha; Bari, Ausaf A; Farrenburg, Mark; Fong-Isariyawongse, Joanna; Henninger, Heidi; Jewell, Armin; Orciuoli, Lauren; Pellinen, Jacob; Stanton, Tom; Hopp, Jennifer L; French, Jacqueline A
PMCID:13283606
PMID: 42333213
ISSN: 1535-7597
CID: 6055502

Research priorities for advancing mental health in elite sport: a companion to the IOC consensus statement on mental health in elite athletes

Kroshus-Havril, Emily; Reardon, Claudia L; Gouttebarge, Vincent; Aron, Cindy Miller; Bahr, Roald; Blauwet, Cheri; Castaldelli-Maia, João Mauricio; Cheng, Camille; Currie, Alan; Derevensky, Jeffrey Lee; Edwards, Carla; Fussek, Sarah; Gorczynski, Paul; Grandner, Michael A; Han, Doug Hyun; Hitchcock, Mary E; Lu, Frank; Massey, Andrew; McDuff, David; Mountjoy, Margo; Purcell, Rosemary; Putukian, Margot; Rice, Simon M; Sloan, Scott; Soligard, Torbjørn; Sundgot-Borgen, Jorunn Kaiander; Swartz, Leslie; Thornton, Jane S; Tshube, Tshepang; Hainline, Brian
PMID: 42331600
ISSN: 1473-0480
CID: 6055412

Acute and Long-Term EEG and seizure characteristics in new onset refractory status epilepticus (NORSE)

Gilani, Kia; Hanin, Aurélie; Gaspard, Nicolas; Batra, Ayush; Behrndt, Laken; Day, Gregory S; Demeret, Sophie; Eschbach, Krista; Foreman, Brandon; Gerard, Elizabeth E; Gofton, Teneille E; Gopaul, Margaret T; Haider, Hiba A; Hantus, Stephen T; Cobos-Hernandez, Carla; Jimenez, Anthony D; Jongeling, Amy; Kandula, Padmaja; Kang, Peter; Kazazian, Karnig; Kellogg, Marissa; Kim, Minjee; Farias-Moeller, Raquel; Morales, Mikaela; Navarro, Vincent; Pimentel, Cederic M; Ramirez, Alexandra; Steriade, Claude; Struck, Aaron F; Taraschenko, Olga; Wainwright, Mark S; Zhou, Daniel J; Hirsch, Lawrence J; Yoo, Ji Yeoun
OBJECTIVE:This study was undertaken to examine acute and chronic electroencephalographic (EEG) and seizure characteristics in new onset refractory status epilepticus (NORSE). METHODS:Multicenter inpatient and follow-up clinical and EEG data were analyzed using International League Against Epilepsy definitions and American Clinical Neurophysiology Society (ACNS) EEG terminology. RESULTS:Forty-four patients were included from the Yale NORSE/FIRES Biorepository (median age = 29 years, 33 female, 38 cryptogenic). Nine hundred twenty inpatient EEG days were reviewed (median = 13.5 days/patient). Presenting status epilepticus (SE) types included 24 convulsive SE (CSE), five focal-motor (FMSE), and 15 nonconvulsive (NCSE). Of 39 patients with post discharge follow-up (median = 14.7 months), 61.5% (n = 24) had seizures and required more antiseizure medications than seizure-free patients (median = 4 vs. 1, p < .001). Inpatient EEG captured epileptiform discharges in all and periodic discharges in 38 patients. Seizures were captured in 38 patients: 33 electrographic (11 only electrographic) and 27 electroclinical. Total seizure burden ranged 6.5-29 615.0 min (median = 50.7). Seizures fulfilling ACNS EEG criteria for SE were captured in 20 patients; two had CSE and the remainder NCSE with coma, nine of whom also had FMSE. Inpatient seizure days (median = 50.0 vs. 15.5%, p = .004) and seizure burden (median = 42.9 vs. 0 min, p = .009) were higher in the first half of monitored days. Interictal findings were equally present and did not predict postdischarge seizures, whereas electroclinical seizures (90.9% vs. 45.5%, p = .037), seizure burden (median = 116.8 vs. 32.5 min, p = .045), and proportion of seizure days (36.3% vs. 20.0%, p = .037) did. Among 12 patients with follow-up EEGs (median = 19.6 months post onset), posterior-dominant rhythm (PDR) returned in nine; five had periodic discharges, and three had seizure captured. SIGNIFICANCE/CONCLUSIONS:Seizures are most commonly convulsive upon presentation and nonconvulsive or clinically subtle throughout the inpatient course in NORSE. Inpatient seizures, but not interictal abnormalities, occur earlier in the inpatient course and presence of electroclinical seizures, seizure burden, and proportion of seizure days but not interictal findings are associated with postdischarge seizures. Although return of PDR reflects neurological recovery, seizure persistence and EEG abnormalities post-NORSE are common.
PMID: 42359767
ISSN: 1528-1167
CID: 6056432