Lalit Bansal, Kailash Pawar, Lines Vargas, Santosh A Helekar
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.
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.