Low-Intensity Focused Ultrasound Neuromodulation for Epilepsy

NCT07353918 | Enrolling By Invitation FDA Device

• 1 other identifier: IRB-24-2194
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epilepsy (Treatment Refractory); Epilepsy Comorbidities

Keywords

LIFU; Neuromodulation; Seizure

Outcome Measures

Primary Outcomes (1)

• Seizure Frequency

  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 Outcomes (3)

• Report of Symptoms Questionnaires

  Within session, approximately over a 3 hour period.

• Memory Encoding

  Within session, over approximately 3 hours.

• Working Memory Task

  Within session, over approximately 3 hours.

Study Arms (2)

LIFU- real

EXPERIMENTAL

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

Device: Low-intensity Focused Ultrasound

LIFU - Sham

SHAM COMPARATOR

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

Device: Sham

Interventions

Low-intensity Focused Ultrasound DEVICE

focused ultrasound transducer.

LIFU- real

Sham DEVICE

Sham application of LIFU - energy blocked. Targeted to the same target as intervention.

LIFU - Sham

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carilion Clinic: lead

Study Sites (1)

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aashit Shah, MD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will not know which visit is real and which is sham. Both appear identical to the participant. The sham is performed by blocking the energy applied to the skull during LIFU. Analysis will be done prior to unblinding researchers. Only researchers interacting with the participant will know visit order.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a within subject cross-over design with 1 visit with a real LIFU application, and 1 visit with a sham LIFU application. Order will be randomized.

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 21, 2026
• Study Start: October 13, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)