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Efficacy of Intersectional Short Pulse Stimulation for Terminating Seizures

Primary Purpose

Seizures, Focal Epilepsy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SeizureStop Device
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seizures

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Sham Comparator

    Experimental

    No Intervention

    Arm Label

    Sham Stimulation

    ISP Stimulation

    Perpheral Stimulation

    Arm Description

    Outcomes

    Primary Outcome Measures

    Mean duration of seizures detected

    Secondary Outcome Measures

    Full Information

    First Posted
    August 4, 2021
    Last Updated
    February 17, 2023
    Sponsor
    NYU Langone Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04998123
    Brief Title
    Efficacy of Intersectional Short Pulse Stimulation for Terminating Seizures
    Official Title
    A Randomized, Sham-controlled Study of the Efficacy of Intersectional Short Pulse (ISP) Stimulation for Seizure Termination
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    July 2026 (Anticipated)
    Study Completion Date
    December 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NYU Langone Health

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Seizures, Focal Epilepsy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sham Stimulation
    Arm Type
    Sham Comparator
    Arm Title
    ISP Stimulation
    Arm Type
    Experimental
    Arm Title
    Perpheral Stimulation
    Arm Type
    No Intervention
    Intervention Type
    Device
    Intervention Name(s)
    SeizureStop Device
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Mean duration of seizures detected
    Time Frame
    up to Day 10

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anli Liu, MD, MA
    Phone
    (929) 455-2323
    Email
    Anli.Liu@nyulangone.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anli Liu, MD, MA
    Organizational Affiliation
    NYU Langone Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
    IPD Sharing Time Frame
    Beginning 3 months and ending 5 years following article publication.
    IPD Sharing 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).

    Learn more about this trial

    Efficacy of Intersectional Short Pulse Stimulation for Terminating Seizures

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