NCT07353918

Low-Intensity Focused Ultrasound Neuromodulation for Epilepsy

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Carilion Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Epilepsy (Treatment Refractory)
• Epilepsy Comorbidities

Interventions

Type	Name	Description
DEVICE	Low-intensity Focused Ultrasound	focused ultrasound transducer.
DEVICE	Sham	Sham application of LIFU - energy blocked. Targeted to the same target as intervention.

Timeline

• Start date: 2025-10-13
• Primary completion: 2027-12-01
• Completion: 2028-05-01
• First posted: 2026-01-21
• Last updated: 2026-01-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study