Recruiting

PLIFU

Sponsor:

Yale University

Code:

NCT05784805

Conditions

Seizures

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Interventions

PLIFU

Study Details

Brief 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.

Conditions

Seizures

Study ID

NCT05784805

Start date

Jun 24, 2023

Status verified date

Oct, 2025

Completion date

Feb, 2026

Anticipated

Primary completion date

Feb, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

PLIFU

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Imran Quraishi, MD

(203) 785-3865imran.quraishi@yale.edu

Locations

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06520

More Information

Sponsor

Yale University

Last update posted

Oct 29, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2025-10-29.