Acute Effects of Focused Ultrasound Modulation on EEG Behavior in Status Epilepticus Patients

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05784805
Status
Recruiting
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Conditions

  • Seizures

Eligibility Criteria

Sex
ALL
Age
19 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • PLIFU — DEVICE
    Participants will be treated with up to 2 sessions of PLIFU (on the same day), while monitored with surface EEG and will be observed for the remainder of the hospital stay as deemed by the primary care team. The system non-invasively delivers ultrasound sonications intracranially that selectively target specific areas of the brain.

Study Details

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.

Key Dates

Start date
Jun 24, 2023
Status verified
Oct 2025
Primary completion
Feb 28, 2026
Completion
Feb 28, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants with ongoing non-convulsive or focal motor SE
    Adult patients with ongoing non-convulsive or focal motor SE despite treatment with at least 2 ASMs and who are monitored with surface EEG will be screened and enrolled to receive up to 2 sessions of PLIFU.

Primary Outcome Measure

Change in epileptiform activity [ Time Frame: baseline and 10 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale New Haven HospitalNew HavenConnecticut06520-

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By research site
Yale New Haven Hospital· New Haven, CT

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