Efficacy of Intersectional Short Pulse Stimulation for Terminating Seizures
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About
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.
Sex
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Volunteers
Inclusion and exclusion 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).
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 3 patient groups
Trial contacts and locations
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Central trial contact
Anli Liu, MD, MA
Data sourced from clinicaltrials.gov
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