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Sound waves aimed at the brain could tame epilepsy seizures

NCT ID NCT03868293

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot trial tests whether repeated sessions of pulsed low-intensity focused ultrasound can safely reduce seizures in people with drug-resistant temporal lobe epilepsy. Ten adults who still have seizures despite medication will receive the ultrasound treatment. Researchers will check for side effects and measure changes in seizure frequency and brain activity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pulsed low-intensity focused ultrasound (device)
What this could lead to
If it works, this could point toward a non-invasive treatment to reduce seizures in people with drug-resistant epilepsy.
What could go wrong
This is a very small pilot study with only 10 participants, so results may not apply widely. The treatment may not reduce seizures or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2019

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects at least eighteen (18) years of age * Subjects with drug-resistant temporal lobe epilepsy whose seizures involve altered awareness (ie failed at least two trials of antiepileptic drugs for seizures), as determined by one of the BWH epilepsy neurologists based on clinical seizure semiology and/or EEG findings. * Subjects who experience at least 1-2 seizures per month on average, are aware of or have reliable caregivers who are aware of when seizures occur and can reliably log seizure frequency * Subjects who have the cognitive ability to read and understand the consent form, describe any potential symptoms experienced during or after treatments. Exclusion Criteria: * Subjects with a cognitive or psychiatric disorder that limits the ability to give informed consent or are unable to cooperate with testing * Subjects with dementia or other progressive degenerative disease, delirium or active psychosis * Subjects with ferromagnetic materials in the head * Subjects with severe cardiac disease, increased intracranial pressure, or a Transcutaneous Electrical Nerve Stimulation (TENS) unit * Subjects who have primary generalized epilepsy or non-epileptic seizures * Subjects who have experienced status epilepticus in the 3 months leading up to enrollment in the study * Subjects (females) who are pregnant, or are of childbearing potential and not willing to use reliable birth control during the treatment period. * Subjects who are unable to get a brain MRI for any reason (implanted metal in body, inability to lie still) * Subjects with current brain tumors or an intracranial vascular lesion * Subjects with severe, uncontrolled medical problems, such as diabetes mellitus, hypertension, pulmonary or airway disease, heart failure, coronary artery disease, or any other condition that poses a risk for the subject during participation. * Subjects with holes in the treatment area of the skull from trauma or prior surgery * Subjects with pacemakers, medication pumps, and other implanted electronic hardware. If a subject has a working Vagal Nerve Stimulator in place, the device will be turned off prior to each treatment session and then turned back on after each session.

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Conditions

The condition(s) this trial relates to.

Drug Resistant Epilepsy temporal lobe epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Brigham and women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

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