A Randomized, Sham-controlled Study of the Efficacy of Intersectional Short Pulse (ISP) Stimulation for Seizure Termination
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- Withdrawn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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Mean duration of seizures detected
Time Frame: up to Day 10