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
About this trial
This is an interventional treatment trial for Seizures
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).
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
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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