Efficacy of Intersectional Short Pulse Stimulation for Terminating Seizures

Study Overview
=================
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.

Official Title
-----------------
A Randomized, Sham-controlled Study of the Efficacy of Intersectional Short Pulse (ISP) Stimulation for Seizure Termination

Conditions
-----------------
Seizures, Focal Epilepsy

Intervention / Treatment
-----------------
* Device: SeizureStop Device


Participation Criteria
=================
Eligibility 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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham Stimulation<br> | Device: SeizureStop Device<br>* 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.<br>|
| Experimental: ISP Stimulation<br> | Device: SeizureStop Device<br>* 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.<br>|
| No Intervention: Perpheral Stimulation<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean duration of seizures detected |  | up to Day 10 |