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Did not receive funding for the study.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Stimulation | Sham Comparator |
| |
| ISP Stimulation | Experimental |
| |
| Perpheral Stimulation | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean duration of seizures detected | up to Day 10 |
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Experiment 3: Epilepsy patients
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anli Liu, MD, MA | NYU Langone Health | Principal Investigator |
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Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Beginning 3 months and ending 5 years following article publication.
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).
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| ID | Term |
|---|---|
| D012640 | Seizures |
| D004828 | Epilepsies, Partial |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |