An interventional study of Low-intensity Focused Ultrasound and Sham in Epilepsy (Treatment Refractory) and Epilepsy Comorbidities, sponsored by Carilion Clinic. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Carilion Clinic · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Low-intensity focused ultrasound will be applied to the entorhinal cortex in a pre/post design.
Device: Low-intensity Focused Ultrasound
Sham Low-intensity focused ultrasound will be applied to the entorhinal cortex in a pre/post design.
Device: Sham
focused ultrasound transducer.
Sham application of LIFU - energy blocked. Targeted to the same target as intervention.
Seizure Frequency
Utilizing the implanted RNS system patient seizure frequency will be monitored over time following both real and sham intervention.
Time frame: 6 months past their final research study visit
Report of Symptoms Questionnaires
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
Time frame: Within session, approximately over a 3 hour period.
Memory Encoding
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.
Time frame: Within session, over approximately 3 hours.
Working Memory Task
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.
Time frame: Within session, over approximately 3 hours.
Plan to share: No
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