Pilot Safety and Feasibility Study of Non-invasive Limb Proprioceptive Cerebellar Stimulation for Epilepsy.

Ronald M Harper,Ashley Curtis,Dieter Hertling,Christopher M De Giorgio,Eberhardt K Sauerland

doi:10.3389/fneur.2021.675947

Abstract

Cerebellar stimulation reduces seizures in animals and in humans with drug-resistant epilepsy. In a pilot safety and feasibility study, we applied continuous cutaneous vibratory stimulation (limb proprioceptive cerebellar stimulation) to foot limb proprioceptive receptors to activate cerebellar, pontine, and thalamic structures in drug-resistant epilepsy patients for 8-h nocturnally up to 6-months after a 4-week pre-treatment control baseline. Seizure frequency was evaluated during the baseline control period, and at 6, 12, and 24 weeks after the control recordings. Five-subjects completed at least the first 6-week treatment. At 12-weeks, the median reduction in seizure frequency was −27.8% (mean reduction = −22.3%). Two subjects continued for 24 weeks, with a decline of −44.1 and −45.4%. This pilot study provides support for further clinical studies into the safety and efficacy of limb proprioceptive cerebellar stimulation for epilepsy.

Highlights

There is evidence that peripheral sensory stimuli suppress epileptic discharges and seizures in animals and humans [1,2,3,4,5,6]
After institutional review board approval and written informed consent by the patient or guardian, five subjects, aged 22-36 years-old (4 males, 1 female) with drug resistant epilepsy were enrolled in this pilot safety and feasibility study of non-invasive limb proprioceptive cerebellar stimulation
No changes in antiepileptic drugs were allowed unless needed for seizure safety

Summary

Introduction

There is evidence that peripheral sensory stimuli suppress epileptic discharges and seizures in animals and humans [1,2,3,4,5,6]. Such peripheral stimulation activates proprioceptive and sensory pathways which project to cerebellar and thalamic structures. Cerebellar regulatory processes are central to protection and recovery from prolonged apnea and extreme hypotension [20, 21], conditions central to Sudden Unexpected Death in Epilepsy (SUDEP) [22, 23]. Devices which protect against peri-ictal apnea, hypotension and seizures may theoretically reduce SUDEP risk and reduce seizures in people with drug resistant epilepsy

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Conclusion