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New treatment option for Seizures
Official title Acute Effects of Focused Ultrasound Modulation on EEG Behavior in Status Epilepticus Patients
ClinicalTrials.gov ID: NCT05784805
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 85
You may be able to join if
- people 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
You likely can't join if
- 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
- people with ferromagnetic materials in the head
See the full eligibility criteria
- people 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
- 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
- people with ferromagnetic materials in the head
- people with a TENS unit
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.