EMAGINE–Study protocol of a randomized controlled trial for determining the efficacy of a frequency tuned electromagnetic field treatment in facilitating recovery within the subacute phase following ischemic stroke

Frontiers in Neurology

Neurology

Natan M. Bornstein¹  Arielle Hochberg²  Assaf Lifshitz²  Jeffrey L. Saver³  Steven C. Cramer⁴  Janice J. Eng⁵  Pamela W. Duncan⁶  Joel Stein⁷ 

[1] Brain Division, Shaare Zedek Medical Center, Jerusalem, Israel;BrainQ Technologies Ltd., Jerusalem, Israel;Department of Neurology, University of California, Los Angeles, Los Angeles, CA, United States;Department of Neurology, University of California, Los Angeles, Los Angeles, CA, United States;California Rehabilitation Institute, Los Angeles, CA, United States;Department of Physical Therapy, University of British Columbia, Vancouver, BC, Canada;School of Medicine, Wake Forest University, Winston-Salem, NC, United States;Weill Cornell Medicine, Cornell University, White Plains, NY, United States;

关键词: subacute stroke;    ELF-EMF;    stroke recovery;    neurostimulation;    non-invasive;    electromagnetic field;    motor recovery;    upper extremity motor impairment;   

DOI  :  10.3389/fneur.2023.1148074

 received in 2023-01-19, accepted in 2023-04-03,  发布年份 2023

来源: Frontiers

【 摘 要 】

Stroke is a leading cause of disability with limited effective interventions that improve recovery in the subacute phase. This protocol aims to evaluate the safety and efficacy of a non-invasive, extremely low-frequency, low-intensity, frequency-tuned electromagnetic field treatment [Electromagnetic Network Targeting Field (ENTF) therapy] in reducing disability and promoting recovery in people with subacute ischemic stroke (IS) with moderate-severe disability and upper extremity (UE) motor impairment. Following a sample-size adaptive design with a single interim analysis, at least 150 and up to 344 participants will be recruited to detect a 0.5-point (with a minimum of 0.33 points) difference on the modified Rankin Scale (mRS) between groups with 80% power at a 5% significance level. This ElectroMAGnetic field Ischemic stroke–Novel subacutE treatment (EMAGINE) trial is a multicenter, double-blind, randomized, sham-controlled, parallel two-arm study to be conducted at approximately 20 United States sites, and enroll participants with subacute IS and moderate-severe disability with UE motor impairment. Participants will be assigned to active (ENTF) or sham treatment, initiated 4–21 days after stroke onset. The intervention, applied to the central nervous system, is designed for suitability in multiple clinical settings and at home. Primary endpoint is change in mRS score from baseline to 90 days post-stroke. Secondary endpoints: change from baseline to 90 days post-stroke on the Fugl-Meyer Assessment - UE (lead secondary endpoint), Box and Block Test, 10-Meter Walk, and others, to be analyzed in a hierarchical manner. EMAGINE will evaluate whether ENTF therapy is safe and effective at reducing disability following subacute IS.Trial registrationwww.ClinicalTrials.gov, NCT05044507 (14 September 2021).

【 授权许可】

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Copyright © 2023 Saver, Duncan, Stein, Cramer, Eng, Lifshitz, Hochberg and Bornstein.