Currently submitted to: JMIR Research Protocols
Date Submitted: Sep 14, 2026
Open Peer Review Period: Sep 15, 2026 - Nov 10, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
High-Frequency Repetitive Peripheral Magnetic Stimulation Targeting Facial Muscle Regions Combined with Conventional Rehabilitation for Recovery-Phase Idiopathic Facial Paralysis: A Randomized Controlled Trial Protocol
ABSTRACT
Background:
Idiopathic facial paralysis (Bell’s palsy) is the most frequent peripheral facial nerve disorder that may cause long-term facial weakness, synkinesis and reduced quality of life. Many patients achieve spontaneous recovery, yet optimized rehabilitation for incomplete facial function remains lacking. Repetitive peripheral magnetic stimulation (rPMS) shows promise for neuromuscular rehabilitation, but evidence for individualized facial-muscle-targeted high-frequency rPMS in recovery-phase patients is limited.
Objective:
To investigate the efficacy, safety and feasibility of individualized high-frequency rPMS added to conventional rehabilitation for patients with recovery-phase idiopathic facial palsy.
Methods:
This single-center, assessor-blinded, 1:1 parallel randomized controlled trial will enroll 148 participants receiving standardized conventional rehabilitation; the intervention group will add high-frequency rPMS tailored to impaired facial muscles according to facial-nerve branch anatomy. The primary outcome is 12-week change in Sunnybrook Facial Grading System scores. Secondary measures include House-Brackmann grade, Burres-Fisch assessment, facial-nerve electrophysiology and high-frequency ultrasound parameters. Intention-to-treat linear mixed-effects models will analyse group-time interactions, with safety and adherence monitored continuously.
Results:
Recruitment has started and remains ongoing. Outcome data collection is not yet completed. Linear mixed-effects models based on the intention-to-treat principle will be used to test group-by-time interactions for primary and secondary outcomes. Adverse events and treatment adherence will be monitored throughout the 12-week intervention period.
Conclusions:
This trial will provide preliminary evidence regarding the efficacy, safety and feasibility of individualized high-frequency rPMS as an add-on rehabilitation strategy for recovery-phase idiopathic facial palsy. Findings may support future multicenter trials on non-invasive neuromodulation for facial rehabilitation. Clinical Trial: ChiCTR2600128252
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