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Enrolling by Invitation

NCT Number: NCT07353918

Low-Intensity Focused Ultrasound Neuromodulation for 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.

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Key information

Conditions

Epilepsy (treatment Refractory) Brain Diseases Central Nervous System Diseases Epilepsy Epilepsy Comorbidities Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-intensity focused ultrasound

Device

focused ultrasound transducer.

SHAM

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Carilion Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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