Efficacy of Intersectional Short Pulse Stimulation for Terminating Seizures

NCT04998123 | Withdrawn DMC FDA Device

• 1 other identifier: 20-00698
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Seizures; Focal Epilepsy

Outcome Measures

Primary Outcomes (1)

• Mean duration of seizures detected

  up to Day 10

Study Arms (3)

Sham Stimulation

SHAM COMPARATOR

Device: SeizureStop Device

ISP Stimulation

EXPERIMENTAL

Device: SeizureStop Device

Perpheral Stimulation

NO INTERVENTION

Interventions

SeizureStop Device 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.

ISP Stimulation; Sham Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Conditions

Seizures; Epilepsies, Partial

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Epilepsy; Brain Diseases; Central Nervous System Diseases

Study Officials

• Anli Liu, MD, MA

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The subject will be blinded to the treatment condition. The study team clinician will be aware of the treatment condition to provide to the clinical team any necessary information for clinical care. Decisions by expert review of EEG on seizure duration will be blinded to treatment condition as well.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 10, 2021
• Study Start: January 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal will have access to the data upon reasonable request. Data are available for 5 years at a third party website (Link to be included).