SeizuresNCT05784805
Acute Effects of Focused Ultrasound Modulation on EEG Behavior in Status Epilepticus Patients
A study testing PLIFU in people with Seizures, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Seizures
- What is being tested?
- PLIFU
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale New Haven Hospital
New Haven, Connecticut, 06520
About this study
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.
Read the detailed description
This study proposes to sonicate epileptic zones or circuits at the bedside with a custom built PLIFU device in two groups of participants experiencing non-convulsive seizures while treated in the Intensive Care Unit (ICU): 1) non-convulsive SE or 2) focal motor Status Epilepticus (SE), targeting the thalami or motor cortical areas responsible for generating ictal activity, respectively.
PLIFU modulation is non-ablative, nonionizing, and noninvasive, while it also preserves the integrity and function of brain tissue. The aim is to quantify ictal and interictal EEG before, during, and after sonication. Experiments will not alter the standard of care and only be implemented after antiseizure medications (ASMs) have been delivered to the patient. PLIFU sonication will be delivered to participants using burst tone and nonthermal parameters for 10 minute exposures.
Hypothesis: PLIFU is a safe and non-invasive treatment that can reduce or suppress epileptic activity.
The pilot data acquired is intended to be used as preliminary data for justifying a larger study.
Recruitment was put on hold from Dec. 2023 to Oct. 2024 due to personnel changes and modifications to study needing approval.
- Conditions
- Seizures
- Being tested
- PLIFU
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLIFUDevice
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 group | Role | What they receive |
|---|---|---|
| Participants with ongoing non-convulsive or focal motor SE | Experimental | 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. Receives: Device: PLIFU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in epileptiform activity
To determine the effect of PLIFU (duration of 10 minutes) on epileptic activity in participants with NCSE/FMSE that have not responded to standard of care using continuous surface EEG. A reduction or suppression of epileptic activity indicates a positive outcome.
Measured: baseline and 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start24 Jun 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeizuresStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Adult patients with ongoing non-convulsive or focal motor SE despite treatment with standard of care antiseizure medications.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Swebilius Foundation
- Responsible party
- Sponsor
- Investigators
- Imran Quraishi, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784805
- Sponsor's protocol ID
- 2000034504
- Other IDs
- No NIH funding
- Status last verified
- Sep 2026
- First submitted
- 13 Mar 2023
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Focused Ultrasound Modulation on EEG Behavior in Status Epilepticus Patients
- ClinicalTrials.gov ID
- NCT05784805
- Acronym / sponsor ID
- 2000034504
- Conditions
- Seizures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Swebilius Foundation
- Study start
- 24 Jun 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study proposes to sonicate epileptic zones or circuits at the bedside with a custom built PLIFU device in two groups of participants experiencing non-convulsive seizures while treated in the Intensive Care Unit (ICU): 1) non-convulsive SE or 2) focal motor Status Epilepticus (SE), targeting the thalami or motor cortical areas responsible for generating ictal activity, respectively.
PLIFU modulation is non-ablative, nonionizing, and noninvasive, while it also preserves the integrity and function of brain tissue. The aim is to quantify ictal and interictal EEG before, during, and after sonication. Experiments will not alter the standard of care and only be implemented after antiseizure medications (ASMs) have been delivered to the patient. PLIFU sonication will be delivered to participants using burst tone and nonthermal parameters for 10 minute exposures.
Hypothesis: PLIFU is a safe and non-invasive treatment that can reduce or suppress epileptic activity.
The pilot data acquired is intended to be used as preliminary data for justifying a larger study.
Recruitment was put on hold from Dec. 2023 to Oct. 2024 due to personnel changes and modifications to study needing approval.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Adult patients with ongoing non-convulsive or focal motor SE despite treatment with standard of care antiseizure medications.
| Arm | Type | Receives |
|---|---|---|
| Participants with ongoing non-convulsive or focal motor SE | Experimental | Device: PLIFUAdult 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. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLIFUParticipants 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. | Device | Participants with ongoing non-convulsive or focal motor SE |
Primary outcome
Change in epileptiform activity
Time frame: baseline and 10 minutes
To determine the effect of PLIFU (duration of 10 minutes) on epileptic activity in participants with NCSE/FMSE that have not responded to standard of care using continuous surface EEG. A reduction or suppression of epileptic activity indicates a positive outcome.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Imran Quraishi, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLIFU in people with Seizures, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Quraishi, MD ((203) 785-3865, imran.quraishi@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in epileptiform activity (time frame: baseline and 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.