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Efficacy of Intersectional Short Pulse Stimulation for Terminating Seizures

NCT ID: NCT04998123

Last Updated: 2024-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Seizures Focal Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Sham Stimulation

Group Type SHAM_COMPARATOR

SeizureStop Device

Intervention Type 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

Group Type EXPERIMENTAL

SeizureStop Device

Intervention Type 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.

Perpheral Stimulation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anli Liu, MD, MA

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Other Identifiers

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20-00698

Identifier Type: -

Identifier Source: org_study_id