Low-Intensity Focused Ultrasound Neuromodulation for Epilepsy

Carilion Clinic

Status: Invitation-only

Conditions: Epilepsy Comorbidities; Epilepsy (Treatment Refractory)

Treatments: Device: Low-intensity Focused Ultrasound; Device: Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT07353918

IRB-24-2194

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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6 participants in 2 patient groups

LIFU- real

Experimental group

Description:

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

Treatment:

Device: Low-intensity Focused Ultrasound

LIFU - Sham

Sham Comparator group

Description:

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

Treatment:

Device: Sham