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临床试验/NCT07353918
NCT07353918Enrolling By Invitation不适用

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

Carilion Clinic0 个研究点目标入组 6 人开始时间: 2025年10月13日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
6

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究者

申办方类型
Other
责任方
Sponsor

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