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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LIFU- real | Experimental | Low-intensity focused ultrasound will be applied to the entorhinal cortex in a pre/post design. |
|
| LIFU - Sham | Sham Comparator | Sham Low-intensity focused ultrasound will be applied to the entorhinal cortex in a pre/post design. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-intensity Focused Ultrasound | Device | focused ultrasound transducer. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within session, approximately over a 3 hour period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aashit Shah, MD | Carilion Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fralin Biomedical Research Institute at VTC | Roanoke | Virginia | 24016 | United States |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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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.
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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.
| Sham |
| Device |
Sham application of LIFU - energy blocked. Targeted to the same target as intervention. |
|
| 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. |
| 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. | Within session, over approximately 3 hours. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |