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.

AI: Melanie Research RF Safe Research Library Jan 1, 2023 NEUTRAL MEDIUM

This paper presents the protocol for the EMAGINE multicenter, double-blind, randomized, sham-controlled trial testing an extremely low-frequency, low-intensity, frequency-tuned electromagnetic field therapy (ENTF) after subacute ischemic stroke. Participants will start active or sham treatment 4–21 days post-stroke, with the primary endpoint being change in modified Rankin Scale at 90 days. The abstract reports planned design features and endpoints but does not provide safety or efficacy results.

Key points

The study is a multicenter, double-blind, randomized, sham-controlled, parallel two-arm trial conducted at ~20 U.S. sites.
It evaluates a non-invasive, extremely low-frequency, low-intensity, frequency-tuned electromagnetic field intervention (ENTF) applied to the central nervous system.
Eligible participants have subacute ischemic stroke with moderate-severe disability and upper extremity motor impairment.
Treatment is initiated 4–21 days after stroke onset, with follow-up to 90 days post-stroke.
The primary outcome is change in modified Rankin Scale from baseline to 90 days.
Secondary outcomes include upper extremity motor function (Fugl-Meyer UE), dexterity (Box and Block), and gait speed (10-Meter Walk).
The design includes a sample-size adaptive approach with a single interim analysis and planned recruitment of at least 150 up to 344 participants.
The abstract provides no trial results, only the planned evaluation of safety and efficacy.

Referenced studies & papers

Relevant papers in OpenMel

Source: Open original

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