Acute Effects of Focused Ultrasound Modulation on EEG Behavior in Status Epilepticus Patie
In this study, the investigators propose Pulsed Low-Intensity Focused Ultrasound (PLIFU) stimulation of brain regions that modulate (thalamus) or generate focal motor seizures (primary motor cortex), with the goal of ameliorating seizure activity in subjects in non-convulsive or focal motor status epilepticus. The cour
| Condition(s) | Seizures |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | In this study, the investigators propose Pulsed Low-Intensity Focused Ultrasound (PLIFU) stimulation of brain regions that modulate (thalamus) or generate focal motor seizures (primary motor cortex), with the goal of ameliorating seizure activity in subjects in non-convulsive or focal motor status epilepticus. The course of treatment will consist of an initial 10 minute PLIFU treatment session with an option for a 2nd session if necessary. The primary objective of this study is to determine whether PLIFU reduces or suppresses epileptic activity in patients with Non-Convulsive Status Epilepticus (NCSE)/Focal Motor Status Epilepticus (FMSE) that have not responded to standard of care. |
| Who can participate | Inclusion Criteria: * Subjects diagnosed with ongoing NCSE or FMSE despite treatment with at least 2 ASMs * Provision of signed and dated informed consent form obtained from the next-of-kin/legally authorized representative * Treated in the ICU while monitored with continuous scalp EEG electrodes Exclusion Criteria: * Unable to obtain informed consent * Presence of an implanted cranial neuromodulation device for treatment of epilepsy * Pregnancy * Treatment with another investigational drug or other intervention within 24 hr * Presence of burr hole(s) or craniotomy * Subjects with ferromagnetic materials in the head * Subjects with a TENS unit |
| Ages | 19 Years to 85 Years |
| Sex | All |
| Lead sponsor | Yale University |
| Locations | New Haven, Connecticut, United States |
| Start date | 2023-06-24 |
| NCT ID | NCT05784805 |
| Official listing | https://clinicaltrials.gov/study/NCT05784805 |