Low-Intensity Focused Ultrasound Neuromodulation for Epilepsy

January 16, 2026 updated by: Carilion Clinic

Neuromodulation Using Low-intensity Focused Ultrasound for Potential Treatment for Medically Refractory Temporal Lobe Epilepsy

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This project will explore the use of Low-Intensity Focused Ultrasound (LIFU) as a non-invasive method to reduce seizures and potentially enhance cognitive functions in epilepsy patients. LIFU can target specific deep brain areas without surgery, offering an alternative to invasive procedures. The study focuses on patients who have an implanted Responsive Neurostimulation System (RNS). LIFU will be used to stimulate the entorhinal cortex, a brain region involved in both seizure activity and memory formation. Investigators are targeting the perforant pathway from EC to hippocampus, which primarily relies of layers II and III of EC. Therefore, this targeting will ensure that layers II and III of EC are within the beam profile of LIFU. During study visits, participant will receive non-invasive ultrasound stimulation in their brains. Investigators will measure seizure frequency and epileptic activity using the implanted RNS system to assess LIFU's effects for epilepsy. Neuropsychological and memory tests will be conducted before and after LIFU application to detect changes in cognitive functions. Investigators will compare results before and after stimulation to determine LIFU's effectiveness in reducing seizures and potentially improving memory or other cognitive functions.

Study Type

Interventional

Enrollment (Estimated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Roanoke, Virginia, United States, 24016
        • Fralin Biomedical Research Institute at VTC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of medically refractory focal epilepsy of mesial temporal onset
  • RNS system implantation in the hippocampus
  • Prior MRI and CT of the head
  • Able to consent for themselves
  • Internet access

Exclusion Criteria:

  • TBI (ongoing, or in the prior 6 months)
  • Currently pregnant or breastfeeding
  • Progressive diseases - such as autoimmune epilepsies or diagnosis of a progressive neurological disorder
  • Status epilepticus within one year of study start
  • History of suicidal ideation or attempts in the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LIFU- real
Low-intensity focused ultrasound will be applied to the entorhinal cortex in a pre/post design.
Device: Low-intensity Focused Ultrasound
focused ultrasound transducer.
Sham Comparator: LIFU - Sham
Sham Low-intensity focused ultrasound will be applied to the entorhinal cortex in a pre/post design.
Device: Sham
Sham application of LIFU - energy blocked. Targeted to the same target as intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seizure Frequency
Time Frame: 6 months past their final research study visit
Utilizing the implanted RNS system patient seizure frequency will be monitored over time following both real and sham intervention.
6 months past their final research study visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Report of Symptoms Questionnaires
Time Frame: Within session, approximately over a 3 hour period.
To evaluate the safety profile and tolerability of LIFU delivery, measured by a series questionnaires pre and post LIFU application evaluating symptoms and side-effects. Participants are asked to report any existing (pre) & new (post) symptoms
Within session, approximately over a 3 hour period.
Memory Encoding
Time Frame: Within session, over approximately 3 hours.
To evaluate the cognitive effects of LIFU delivery on memory, participants will be assessed for correct vs incorrect encoding (face/name pair shown, & then queried after a distractor task). % correct will be assessed.
Within session, over approximately 3 hours.
Working Memory Task
Time Frame: Within session, over approximately 3 hours.
To evaluate the cognitive effects of LIFU delivery on working memory, participants will be assessed for correct vs incorrect encoding (given a list of objects, asked to recall in smallest to largest order). % correct will be assessed.
Within session, over approximately 3 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carilion Clinic

Investigators

  • Principal Investigator: Aashit Shah, MD, Carilion Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

December 22, 2025

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-24-2194

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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