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NCT04998123 Clinical Trial

Efficacy of Intersectional Short Pulse Stimulation for Terminating Seizures

Seizures Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04998123
Other study ID # 20-00698
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 2025
Est. completion date December 2026

Study information
Verified date January 2024
Source NYU Langone Health
Contact Anli Liu, MD, MA
Phone (929) 455-2323
Email Anli.Liu@nyulangone.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date December 2026
Est. primary completion date July 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• SeizureStop 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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
NYU Langone Health

Outcome
Type Measure Description Time frame Safety issue
Primary Mean duration of seizures detected up to Day 10
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