Transcranial rotating permanent magnet stimulation for focal continuous spike-and-wave during sleep: First-in-human pediatric pilot study.

Document Type

Article

Publication Date

11-2026

Identifier

DOI: 10.1016/j.seizure.2026.09.012

Abstract

OBJECTIVE: Continuous spike-and-wave during sleep (CSWS) is an epileptic encephalopathy characterized by sleep-potentiated epileptiform activity and neurocognitive deterioration. Available therapies are frequently ineffective or poorly tolerated. We evaluated the safety, tolerability, and acute electrophysiologic effects of transcranial rotating permanent magnet stimulation (TRPMS), a novel wearable neuromodulation platform, in patients with focal CSWS.

METHODS: In this prospective, open-label pilot study, 10 children (age range 3-14 years) with focal CSWS underwent a single 10-minute session of focal TRPMS during inpatient epilepsy monitoring between October 2019 through April 2024. Stimulation was targeted at the epileptogenic cortical region identified by scalp electroencephalogram (EEG). Continuous video-EEG recordings were obtained before and after stimulation. The primary outcome was change in spike-wave index (SWI) during non-rapid eye movement sleep. Secondary outcomes included changes in awake SWI, safety, and tolerability. SWI measurements were independently assessed by two blinded pediatric epileptologists.

RESULTS: All participants completed the intervention without interruption. No serious adverse events, stimulation-induced seizures, clinically significant vital sign changes, or device-related complications were observed. Mean sleep SWI decreased from 90.6% to 81.7% for reviewer 1 (p = 0.0186) and from 85.3% to 77.0% for reviewer 2 (p = 0.0123). Mean awake SWI decreased from 49.31% to 35.86% for reviewer 1 (p = 0.0065) and from 44.6% to 34.7% for reviewer 2 (p = 0.0186). Five participants achieved a post-stimulation sleep SWI below 85%, meeting a predefined electrophysiologic response criterion.

SIGNIFICANCE: A single session of focal TRPMS was safe, well tolerated, and associated with significant short-term reductions in spike-wave burden during both sleep and wakefulness in patients with focal CSWS. These findings provide preliminary proof-of-concept evidence that wearable low-intensity magnetic neuromodulation may represent a novel nonpharmacologic treatment approach for CSWS. Controlled studies with repeated stimulation sessions and long-term follow-up are warranted to determine clinical efficacy and durability of response.

Journal Title

Seizure : the journal of the British Epilepsy Association

Volume

142

First Page

262

Last Page

269

MeSH Keywords

Humans; Child; Pilot Projects; Female; Male; Child, Preschool; Adolescent; Transcranial Magnetic Stimulation; Electroencephalography; Sleep; Prospective Studies; Brain Waves; Treatment Outcome

PubMed ID

42763950

Keywords

CSWS; Continuous spike-and-wave during sleep; ESES; Electrical status epilepticus in sleep; TRPMS; Transcranial magnetic stimulation

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