Skip to main content
Clinical Trials/NCT04998123
NCT04998123
Withdrawn
N/A

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

NYU Langone Health0 sites30 target enrollmentJanuary 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Seizures
Sponsor
NYU Langone Health
Enrollment
30
Primary Endpoint
Mean duration of seizures detected
Status
Withdrawn
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
January 2025
End Date
December 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Mean duration of seizures detected

Time Frame: up to Day 10

Similar Trials