Focal Epilepsy, Seizures
Conditions
Brief summary
This is a study which seeks to develop a novel therapeutic approach, Intersectional Short Pulse (ISP) stimulation for seizure termination. The device embodiment of ISP is a scalp EEG recording system which also delivers spatially precise electrical stimulation in short pulses to the targeted brain region. The study team has already collected safety and tolerability data in human subjects, demonstrated ISP efficacy in terminating seizures in rodents, and have tested the efficacy of this device to modulate normal human brain activity. Now this study proposes to test the device's efficacy in stopping seizures in a within-subject randomized, sham-controlled study design.
Interventions
DEVICESeizureStop Device
Intersectional Short Pulse (ISP) Stimulation will be performed using SeizureStop Device. The ISP stimulation method proposed in this study is to increase the intensity of stimulation delivered to targeted brain regions, while minimizing the peripheral effects of stimulation. For sham stimulation, no settings will be modified.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The subject will be blinded to the treatment condition. The study team clinician will be aware of the treatment condition to provide to the clinical team any necessary information for clinical care. Decisions by expert review of EEG on seizure duration will be blinded to treatment condition as well.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Experiment 3: Epilepsy patients Inclusion criteria: * Adult patients (age 18-65). * Fluent in English. * Epilepsy patients with poorly controlled (\>=2 seizures per week). * Focal onset seizures. * Seizure onset zone in the mesial temporal or neocortical onset as determined by \>2 concordant criteria, without discordant criteria (semiology, MRI Brain, and EEG). * Able to give informed consent.
Exclusion criteria
* Patients with skull defects. * Patients with implanted neurostimulator or other implanted cerebral hardware. * Patients with multifocal onset epilepsy. * Patients who are non-verbal or incapable of providing informed consent. * Current substance abuse. * Pregnancy. * Patients with non-MRI compatible implants (for Experiments 2 and 3).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean duration of seizures detected | up to Day 10 |
Outcome results
None listed