Low-Intensity Focused Ultrasound for Epilepsy

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Carilion Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Low-Intensity Focused Ultrasound (LIFU) can assist people with epilepsy, particularly those with hard-to-treat seizures originating in the temporal lobe. The primary aim is to determine if LIFU applied to the brain can effectively manage these seizures. Participants will receive either the actual LIFU treatment or a sham (inactive) version to compare outcomes. The trial is suitable for individuals with an RNS system (a device implanted in the brain to help control seizures), a history of epilepsy, internet access, and recent brain scans. As an unphased trial, it provides a unique opportunity to investigate innovative treatment options for epilepsy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that Low-Intensity Focused Ultrasound is safe for epilepsy patients?

Research has shown that Low-Intensity Focused Ultrasound (LIFU) is generally safe for people. Some studies found that patients with medication-resistant epilepsy experienced fewer seizures after LIFU treatment. These studies primarily assessed the treatment's safety and tolerability. Although research remains in its early stages, no serious side effects have been reported. This suggests that LIFU might be a safe option for those considering participation in a clinical trial. However, discussing any potential risks with a doctor before participating is always important.12345

Why are researchers excited about this trial?

Most treatments for epilepsy focus on medication or surgery to control seizures. However, Low-Intensity Focused Ultrasound (LIFU) offers a novel approach by using sound waves to target specific brain regions, like the entorhinal cortex, without the need for invasive procedures. This technique stands out because it has the potential to modulate brain activity more precisely and with fewer side effects than traditional methods. Researchers are excited because LIFU could offer a non-invasive alternative that might work where other treatments have failed, providing new hope for patients with drug-resistant epilepsy.

What evidence suggests that Low-Intensity Focused Ultrasound is effective for epilepsy?

Research has shown that Low-Intensity Focused Ultrasound (LIFU) may help reduce seizures. Animal studies found that LIFU can decrease seizures without harming the brain, resulting in fewer and shorter seizures. This trial will compare the effects of real LIFU treatment with a sham LIFU treatment. Although most research comes from animal studies, these early findings offer hope for its potential use in people with epilepsy.12678

Who Is on the Research Team?

AS

Aashit Shah, MD

Principal Investigator

Carilion Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with hard-to-treat focal epilepsy originating in the mesial temporal region who have internet access, an RNS system implanted in the hippocampus, and prior head MRI and CT scans. They must be able to consent for themselves.

Inclusion Criteria

I have been diagnosed with hard-to-treat epilepsy that starts in the inner part of my brain.
I have an RNS system implanted in my hippocampus.
I have had an MRI and CT scan of my head.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Low-Intensity Focused Ultrasound (LIFU) stimulation targeting the entorhinal cortex to assess effects on seizure frequency and cognitive functions.

6 months
Multiple visits for LIFU application and assessments

Follow-up

Participants are monitored for seizure frequency and cognitive function changes using the implanted RNS system and neuropsychological tests.

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Low-Intensity Focused Ultrasound

Trial Overview

The study examines Low-Intensity Focused Ultrasound (LIFU) neuromodulation effects on epilepsy patients with implanted electrodes. It's invite-only under Dr. Shah's care, comparing LIFU treatment against a sham procedure.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: LIFU- realExperimental Treatment1 Intervention
Group II: LIFU - ShamPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Carilion Clinic

Lead Sponsor

Trials
85
Recruited
15,400+

Citations

Low Intensity Focused Ultrasound for Epilepsy

Several preclinical studies have demonstrated the ability of LIFUS to suppress seizures in epilepsy animal models without damaging tissue. Electrographic ...

Focused Ultrasound Makes Anti-Epileptic Drug More ...

The preclinical experiments produced fewer seizures and shorter duration of seizure activity.

Study Details | NCT06388707 | A Safety, Tolerability, and ...

The study aims to demonstrate the safety and preliminary efficacy of LIFU neuromodulation in DR-TLE patients, showing its ability to decrease targeted neuronal ...

Recent Advances in the Use of Focused Ultrasound as a ...

The seizure-suppressive effect of LIFU has been studied in several preclinical trials, showing promising results.

Focused ultrasounds: What is their future in epileptology? ...

Yet, open surgery focusing on the resection of the epileptogenic zone (EZ) results in up to 80% seizure-freedom and is thus deemed superior in terms of seizure ...

Clinical Research Trial Listing ( Drug Resistant Epilepsy

A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy.

Low-Intensity Focused Ultrasound Treatment Holds Promise ...

A non-invasive technique called low-intensity focused ultrasound (LOFU) holds promise for treating and preventing seizures in the most common form of epilepsy.

Epilepsy Trial for Focused Ultrasound Neuromodulation ...

Researchers in Taiwan recently published the data from a small pilot clinical trial testing the safety and efficacy of using focused ultrasound ...