Low-Intensity Focused Ultrasound for Epilepsy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Carilion Clinic

Disqualifiers: TBI, Pregnancy, Progressive diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is an invite only study looking at the effects of Low-Intensity Focused Ultrasound (LIFU) on epilepsy patients with implanted electrodes under the care of Dr. Shah.

Who Is on the Research Team?

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.

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?

Group I: LIFU- real Experimental Treatment 1 Intervention

Low-intensity focused ultrasound will be applied to the entorhinal cortex in a pre/post design.

Group II: LIFU - Sham Placebo Group 1 Intervention

Sham Low-intensity focused ultrasound will be applied to the entorhinal cortex in a pre/post design.

Who Is Running the Clinical Trial?

Carilion Clinic

Lead Sponsor

Trials

85

Recruited

15,400+