Electromagnetic Stimulation to Reduce Disability After Ischemic Stroke

作者：Jeffrey L. Saver, Pamela W. Duncan, Joel Stein, Steven C. Cramer, Emily J. Fox, Richard D. Zorowitz, Sandra A. Billinger, Sarah M. Eickmeyer, Steven Kirshblum, Ghaith J. Androwis, Jason Edwards, Sean I. Savitz, Sebastian Koch, Matthew B. Shall, Randie M. Black‐Schaffer, Paolo Bonato, Sara J. Cuccurullo, Jaclyn Barcikowski, Ning Cao, Natan M. Bornstein, EMAGINE 1 Trial Investigators, Cassandra List, Dorian K. Rose, E McNally, Kathaleen Brady, G. Herman, Alexandra Arickx, Michael Abraham, Uri Adler, Guang H. Yue, Nuray Yozbatıran, Emily A. Stevens, Jennifer Cunningham, Mackenzie Gillund, William L. Bockenek, Beverly Queen, Denise Comeaux, Lauren T. Shapiro, Jose G. Romano, W. Dalton Dietrich, Lauri Bishop, Nilanjana Datta, Priyanca B. Shah, David J. Lin, Marc Van de Rijn, Hayk Petrosyan, Talya K. Fleming, Maria Belen Montealegre, Dylan J. Edwards, Alberto B. Esquenazi, Shenbo Huang, Hui Gong, Michelle Armacost, Elliot J. Roth, Arun Jayaraman, Mersedeh Bahr Hosseini, Michael Su, Katherine T Mun, Pamela Roberts, D. Kogan, Sohaib Qadri, André Côté, Keiko Fukuda, Nicole Khezri, Min Sun Kim, Muhammad Bilal Tariq, Philip Y. Sun, Simon Driver, Rosemary Dubiel · 发表于：JAMA Network Open · 年份：2025 · DOI：10.1001/jamanetworkopen.2025.37880 · 被引用次数：2 · 研究领域：Stroke Rehabilitation and Recovery、EEG and Brain-Computer Interfaces、Transcranial Magnetic Stimulation Studies

Importance: Ischemic stroke remains a leading cause of disability worldwide. Preliminary studies have suggested that noninvasive, frequency-tuned, low-intensity electromagnetic network targeting field (ENTF) stimulation may have recovery benefit for patients with stroke. Objective: To evaluate the safety and effectiveness of ENTF therapy in reducing global disability among patients in the subacute ischemic stroke phase with moderate to severe disability and upper-extremity impairment. Design, Setting, and Participants: This multicenter, double-blind, sham-controlled, randomized clinical trial was conducted at 15 US-based acute care and inpatient rehabilitation facilities from December 2021 to November 2023. Participants were enrolled 4 to 21 days after a stroke and had a baseline modified Rankin Scale (mRS) score of 3 or 4 (moderate or moderately severe global disability) and Fugl-Meyer Assessment for Upper Extremity score of 10 to 45 (higher scores indicating better arm function). Target sample size was 150 participants. Participants were randomly allocated to receive either active or sham ENTF stimulation. Modified intention-to-treat approach was used in primary efficacy and safety analyses. Intervention: Participants allocated to the active or sham ENTF stimulation were treated with a proprietary brain-computer interface-based stimulation device paired with an evidence-based, functional, repetitive, home-based physical and occupational exercise regimen for 45 one-hour sess...