Efficacy of Intersectional Short Pulse Stimulation for Terminating Seizures

Not Applicable

Withdrawn

• Conditions: Focal Epilepsy; Seizures
• Interventions: Device: SeizureStop Device

• Registration Number: NCT04998123
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-30
• Study Start: 2025-01
• Primary Completion: 2026-07
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Stimulation	SeizureStop Device	-
ISP Stimulation	SeizureStop Device	-

Primary Outcome Measures

Name	Time	Method
Mean duration of seizures detected	up to Day 10