Searched for: All
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
Chilblain acral lesions in a patient with lupus after COVID-19 infection
Xiao, Teresa L; Ramachandran, Vignesh; Amarnani, Abhimanyu; Izmirly, Peter M; Pomeranz, Miriam Keltz
PMCID:12742483
PMID: 41637619
ISSN: 2328-5273
CID: 6000252
Crutch use for 4 weeks vs. 1 week after hip arthroscopy for femoroacetabular impingement: A pseudorandomized clinical trial with 6-month follow-up
Shankar, Dhruv S; Mojica, Edward S; Blaeser, Anna M; Vasavada, Kinjal D; Bi, Andrew S; Youm, Thomas
BACKGROUND:The purpose of our study was to compare patient-reported outcomes at 6-month follow-up between primary hip arthroscopy patients who were partial weight bearing on crutches for 4 weeks vs. 1 week postoperatively. METHODS:We conducted a pseudorandomized clinical trial involving patients who underwent arthroscopic treatment of femoroacetabular imipingement at a single center from September 2020 to April 2021. Subjects aged 18-65 years old were alternately assigned to one of the 2 rehabilitation regimens involving either 4-week or 1-week partial weight bearing on crutches. Subjects completed the modified Harris Hip Score (mHHS) and Nonarthritic Hip Score (NAHS) surveys before surgery and at 6-month follow-up. Achievement of the minimum clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptom state (PASS) was assessed using published mHHS cutoff values. Outcomes were compared between groups with the Mann-Whitney U test and analysis of covariance, while MCID, SCB, and PASS rates were compared with the Fisher exact test. P-values < .05 were considered significant. RESULTS:Fifty patients were included in the study of whom 28 (56.0%) were assigned to 4-week crutch use and 22 (44.0%) to 1-week crutch use. The 4-week crutch use group was significantly older on average (38.4 vs. 32.1 years, P = .03) and had significantly higher mean body mass index (27.6 vs. 24.5, P = .01), but there were no significant baseline differences between the 2 groups (P > .05). After adjusting for age and body mass index, there was no significant difference in preoperative to postoperative improvement in mHHS (P = .43) or NAHS (P = .46) between the 2 groups at 6-month follow-up. Furthermore, there were no significant differences in achievement rates for MCID (P = .50), SCB (P = .51), or PASS (P = .77) between the 2 groups. CONCLUSION/CONCLUSIONS:We identified no significant differences in improvement of mHHS and NAHS or achievement of the MCID, SCB, or PASS at 6-month follow-up between patients on crutches for 4 weeks vs. 1 week postoperatively. LEVEL OF EVIDENCE/METHODS:II, Pseudorandomized clinical trial.
PMCID:12742497
PMID: 41637607
ISSN: 2328-5273
CID: 6000142
Implementation of a standardized pain management protocol reduces the variability in prescription patterns following pediatric supracondylar humerus fractures
Jeong, Yealeen; Birnbaum, Amy; Cooper, Joie; Castañeda, Pablo; Karamitopoulos, Mara
BACKGROUND:Children and adolescents are vulnerable to the ongoing opioid overdose epidemic in the United States. To minimize pediatric patients' exposure to opioids, efforts are underway to reduce opioid prescriptions after closed reduction and percutaneous pinning (CRPP) for supracondylar humerus fractures. Standardized pain management protocols preferentially using opioid-free analgesics are reported to be effective in managing postoperative pain and limiting the utilization of opioids. This study compares retrospective data collected before and after the implementation of a standardized postoperative pain management protocol at a large academic children's hospital. The primary aim of this study was to compare opioid prescription patterns during the 2 periods. The secondary aim of the study was to determine the effect of the protocol on minimizing prescription errors. METHODS:This Institutional Review Board-approved study was a retrospective review of pediatric patients who underwent CRPP for supracondylar humerus fractures between January 2019 and December 2021. A control cohort of patients treated before the implementation of a department-approved pain management protocol was compared with a cohort of patients treated after the implementation of a standardized postoperative pain management protocol. We compared the number of opioid prescriptions provided to patients before and after the implementation of the protocol. Descriptive statistics and chi-square analyses were used to evaluate prescribing patterns. RESULTS:After the implementation of the standardized pain medication control protocol, we observed a successful decrease in pediatric patients receiving postoperative opioids from 49.6% to 13.6% and in opioid prescribing errors from 38.6% to 12.5%. In addition, there was reduced variability in the type of narcotics prescribed. After the protocol's implementation, the most common combination of medication prescribed for postoperative pain control was acetaminophen and ibuprofen (69.5%). The chi-square test demonstrated no significant association between postoperative opioid prescription and fracture classification or length of stay. CONCLUSION/CONCLUSIONS:Opioid prescription patterns for postoperative pain management after CRPP for supracondylar humerus fractures were highly variable before the introduction of a standardized pain management protocol. The introduction of the standardized guideline effectively decreased the number of opioids prescribed at discharge, resulted in fewer opioid prescribing errors, and reduced variability in prescribing patterns among providers. LEVEL OF EVIDENCE/METHODS:Level IV-retrospective case series.
PMCID:12742484
PMID: 41637605
ISSN: 2328-5273
CID: 6000122
Don't be sidelined: Winning strategies for care of the para athlete
Sacks, Hayley; Karamitopoulos, Mara
The aim of this study was to provide a review for orthopedic surgeons on the care of para athletes. The article focuses on common patient populations that present to orthopedic surgeons, including individuals with spinal cord injuries and related disorders, limb deficiencies, and neuromuscular conditions. The most common types of injuries affecting these para athletes will be discussed, as well as strategies for injury prevention and treatment. This review article also dives into the historical origins of para sports and discusses how treatment can potentially influence classification levels for para athletes. Orthopedic surgeons should encourage their patients with disabilities to participate in para sports, understand the types of injuries they may be at risk of based on disability and sports-specific factors, and work to help keep para athletes successfully competing in the sports they love.
PMCID:12742489
PMID: 41637590
ISSN: 2328-5273
CID: 5999972
Correlation between self-reported outcomes of the hip, knee, and ankle in elite Nordic jumping athletes
Vasavada, Kinjal; Shankar, Dhruv; Chen, Andrew L; Borowski, Lauren; Milton, Heather A; Gonzalez-Lomas, Guillem
BACKGROUND:Nordic combined (NC) and ski jumping (SJ) athletes have a high prevalence of chronic hip pathology, which may lead to altered knee and ankle biomechanics. PURPOSE/OBJECTIVE:The purpose of this study was to determine the relationship among athlete-reported lower extremity outcomes in a proximal-to-distal sequence. STUDY DESIGN/LEVEL OF EVIDENCE/UNASSIGNED:cross-sectional study, Level IV. METHODS:Elite SJ and NC athletes who competed at the national and international levels were prospectively recruited to complete a survey eliciting information about their Hip Disability and Osteoarthritis Outcome Score (HOOS), International Knee Demographic Committee (IKDC) score, and Foot and Ankle Outcome Score (FAOS). Univariate linear regressions modeling IKDC scores and FAOS subscores were performed for each of the following independent variables: age, sex, body mass index, Nordic event (NC or SJ), HOOS subscore, and FAOS subscore or IKDC score, respectively. RESULTS:A total of 22 athletes were included in the study. HOOS symptoms subscores were significantly lower (worse) among SJ athletes compared with NC athletes (P = .002). HOOS quality of life subscores were lower for female athletes compared with male athletes (54 ± 21, 73 ± 4.0; P = .029) in the entire cohort. An increase in the HOOS pain subscore (0.54 ± 0.20, P = .016) and HOOS sports subscore (0.40 ± 0.17, P = .042) was associated with a significant increase in the IKDC score. An increase in the HOOS symptoms subscore (0.63 ± 0.21, P = .011) was associated with a significant increase in the FAOS symptoms subscore. CONCLUSION/CONCLUSIONS:Elite NC and SJ athletes are at high risk of hip pain, which increases their risk of developing knee and ankle pain as well. These findings strongly suggest that training targeted at hip strength and conditioning may optimize knee and ankle outcomes in elite NC and SJ athletes. CLINICAL RELEVANCE/CONCLUSIONS:The results of this study may help guide physicians, allied health personnel, and coaches to alter lower extremity training regimens to decrease the risk of injury.
PMCID:12742511
PMID: 41637613
ISSN: 2328-5273
CID: 6000202
Impact of an endoscopic retrograde cholangiopancreatography radiation safety initiative on pregnant and nonpregnant staff dose exposures: a quality improvement initiative
de Latour, Rabia; David, Yakira; Kothari, Shivangi; Ali, Murad
BACKGROUND AND AIMS/UNASSIGNED:Endoscopic retrograde cholangiopancreatography (ERCP) is a vital procedure for the management of hepatobiliary disease that requires fluoroscopy and results in radiation exposure to the interventional endoscopy team. Prevention of radiation-induced injury is crucial. Prompted by the pregnancy of our advanced endoscopist, who chose to continue performing ERCP throughout the pregnancy, we conducted a radiation safety and quality improvement initiative and evaluated the impact of this on mean fluoroscopy times and radiation dose exposure to the staff present in the procedure room. METHODS/UNASSIGNED:ERCPs performed between June 2018 and March 2020 were reviewed. ERCPs performed from June 2018 to June 2019 were categorized as "preinitiative" and those performed from July 2019 to March 2020 were categorized as "postinitiative." Interventions included purchase of a new fluoroscopy bed, new lead skirt for the bed and c-arm receiver, mindful fluoroscopy use by attending physician only, appropriate wear of dosimeter badges, and quality evaluation of personal protective equipment such as lead shielding. Data were collected on mean fluoroscopy time per procedure and each provider's monthly radiation dosage. RESULTS/UNASSIGNED:< .01). The fetal dosimeter badge worn at waist level of the pregnant provider under the lead shield detected less than the lowest detectable reading every month. CONCLUSIONS/UNASSIGNED:Quality improvement initiatives coupled with adequate personal protective equipment can result in significant improvement in the radiation exposure of advanced endoscopy staff during ERCP. Performing ERCP during pregnancy is a potentially feasible option if proper techniques and policy are implemented to protect the fetus.
PMCID:12850887
PMID: 41647389
ISSN: 2949-7086
CID: 6000542
Premedical Education Experiences of First-Generation College Graduates
Eggan, Branden; Mason, Hyacinth R C; Chakraverty, Devasmita; Diaz, Jacqueline M; Rivera, Valerie; L'Etoile, Hannah; Ascencio, Brandon; Havemann, Catherine; Russell, Regina G; Wyatt, Tasha R; Boatright, Dowin; Nguyen, Mytien
IMPORTANCE/UNASSIGNED:First-generation undergraduate students are underrepresented in medicine and face challenges that affect their application and matriculation to medical school. OBJECTIVE/UNASSIGNED:To understand the barriers and available support at the individual, interpersonal, and organizational levels for first-generation students in premedical programs. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This qualitative study was part of a larger project on professional identity formation among US medical students from low socioeconomic backgrounds with a focus on first-generation undergraduate students. Semistructured online interviews of 48 students (37 of whom were first-generation students) from 27 US medical schools were conducted from November 1, 2021, through April 30, 2022, and secondary analyses regarding their premedical experiences were performed. Interviews were recorded, transcribed, deidentified, assigned an alphanumeric code, and analyzed using an inductive thematic approach from June 1 through December 30, 2024. Participants were offered a $20 gift card in appreciation for their time. EXPOSURE/UNASSIGNED:Experiences of students identifying as first-generation college students in premedical training. MAIN OUTCOMES AND MEASURES/UNASSIGNED:Main outcomes included themes and subthemes at the individual, interpersonal, and organizational levels constructed from interview data. Bronfenbrenner's ecological systems theory was used as a guiding interpretive framework to analyze participants' experiences within their broader social and environmental contexts. This model allowed examination of how individual perspectives were shaped by interactions across personal, social, and structural contexts. The team engaged in reflexive discussions, memos, and consensus-based refinement to identify key themes. RESULTS/UNASSIGNED:Among 37 participants identified as first-generation students, 21 (56.8%) identified as female (mean [SD] age, 27.3 [2.8] years). One participant (2.7%) identified as American Indian or Alaska Native; 7 (18.9%) as Hispanic, Latino, or Spanish origin; 8 (21.6%) as non-Hispanic Asian or Asian American; 9 (24.3%) as non-Hispanic Black or African American; and 12 (32.4%) as non-Hispanic White. Analyses revealed key themes across all 3 levels of the ecological systems model: individual, interpersonal, and organizational. Individual themes included personal and family background, such as financial instability and lack of clinical exposure. Interpersonal themes included access to premedical advisors, faculty mentors, and peer networks. Organizational themes included limited institutional resources and pathway programs. CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this qualitative study of first-generation students, financial instability, limited medical school-related social connections and resources, and unfamiliarity with academic systems were found to uniquely burden these students. By identifying and improving resources such as tailored mentorship, individualized advising, and participation in pathway programs, medical schools can help reduce structural barriers for aspiring physicians who are first-generation college students.
PMID: 41632147
ISSN: 2574-3805
CID: 5999742
Real-world enrollment for a prospective clinico-genomic database using a pragmatic technology-enabled platform
Exarchos, Alexia; Bourla, Ariel B; Kaur, Maneet; Schulze, Katja; Maund, Sophia; Cao, Yi; Zhao, Yihua; Williams, Elizabeth H; Gaffey, Sarah C; Zuniga, Richard; Lakhanpal, Shaily; Antic, Vladan; Doral, Michelle; Sy, Johanna; Meropol, Neal J; Chiang, Anne C
BACKGROUND/UNASSIGNED:Discovery and incorporation of predictive and prognostic biomarkers enhance outcomes for patients with cancer. Clinico-genomic datasets, which retrospectively link real-world clinical data to tumor sequencing data, are important resources for biomarker research, which has historically relied on robust research infrastructures exclusive to large academic centers. The objective was to evaluate the feasibility of a pragmatic, technology-enabled platform at community-based research sites for development of a prospective clinico-genomic database supported by centralized electronic health record (EHR)-based patient ascertainment and data processing. METHODS/UNASSIGNED:Adults with stage IV or recurrent metastatic non-small cell lung cancer or extensive-stage small-cell lung cancer were enrolled at 23 US sites upon initiating a standard line of therapy. Enrollment rates were estimated from eligible populations at individual centers. Clinical data from routinely collected EHR documentation were centrally processed and normalized for quality control. Serial blood samples at pre-specified timepoints (baseline, during treatment and at disease progression/end of therapy) were used for circulating tumor DNA (ctDNA) genomic profiling. RESULTS/UNASSIGNED:Between December 2019 and May 2021, 944 patients enrolled, representing ≈25 % of eligible patients. Eight-hundred seventeen of 944 (87 %), 406 of 606 (67 %) and 398 of 852 (47 %) participants provided qualifying samples for ctDNA testing at baseline, during treatment and at disease progression/end of therapy, respectively. Samples were provided at all three timepoints by 35 % of participants. CONCLUSION/UNASSIGNED:A community-based oncology patient cohort was rapidly enrolled, creating a real-world clinico-genomic dataset. This pragmatic study platform has potential research applications where prospective real-world data may contribute to evidence generation.
PMCID:11869879
PMID: 40027276
ISSN: 2451-8654
CID: 5999162
CLO25-071: The Impact of ChemoMouthpiece Device on Analgesic Use for Oral Pain in a Randomized, Prospective, Multi-Center Trial for Patients Undergoing Stomatoxic Chemotherapy
Dembla, Vikas; Zuniga, Richard
PMID: 40154459
ISSN: 1540-1413
CID: 5999172