A Pilot Study: Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy

Description

The purpose of this study is to assess the safety and feasibility of Magnetic Resonance Imaging-guided focused ultrasound (MRgFUS) in patients with epilepsy whose medicines are not working well. The ExAblate (ExAblate) transcranial system is the name of the device that will be used to create and send ultrasound waves through the scalp and skull precisely to a small structure located in the center of the brain. This structure is known as the "Anterior Nucleus", and is an important region in the brain that may cause the seizures. Safety will be measured by recording and analyzing any adverse effects that may occur from the day of the experimental surgery through 12 months following the surgery.

Conditions

Partial Seizures With Secondary Generalization

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Study Overview

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Study Details

Study overview

The purpose of this study is to assess the safety and feasibility of Magnetic Resonance Imaging-guided focused ultrasound (MRgFUS) in patients with epilepsy whose medicines are not working well. The ExAblate (ExAblate) transcranial system is the name of the device that will be used to create and send ultrasound waves through the scalp and skull precisely to a small structure located in the center of the brain. This structure is known as the "Anterior Nucleus", and is an important region in the brain that may cause the seizures. Safety will be measured by recording and analyzing any adverse effects that may occur from the day of the experimental surgery through 12 months following the surgery.

A Pilot Open-label Clinical Trial Evaluating the ExAblate Model 4000 Type-1 Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy

A Pilot Study: Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy

Condition
Partial Seizures With Secondary Generalization
Intervention / Treatment

-

Contacts and Locations

Chapel Hill

University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, United States, 27599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Disabling, medically refractory epilepsy (≥2 anti-epileptic drug failures)
  • * Focal onset seizures with secondary generalization; with or without primary generalized seizures.
  • * ≥ 3 seizures/month on average within 3 months of enrollment.
  • * Stable medication dosage for 3 months before enrollment.
  • * Anterior Nucleus (AN) identifiable on MRI (structural T1 and T2 images).
  • * Willing to maintain seizure diary (3 months before \& 3 months after).
  • * Involved care provider.
  • * Written informed consent to participate.
  • * Previous seizure work-up within 12 months of enrollment date to include:
  • 1. Home EEG or Epilepsy Monitoring Unit (EMU) video EEG or intracranial EEG.
  • 2. Baseline neuropsychological assessment, which includes the Wechsler Advanced Clinical Solutions - Test of Premorbid Functioning (TOPF). Participants obtaining an Intelligence Quotient (IQ) score of ≥70 on the TOPF will be included.
  • 3. High-definition MRI imaging/Position emission tomography (PET) imaging
  • * Low seizure frequency (\<3 seizures/month).
  • * Indwelling vagal nerve stimulator.
  • * Severe untreated neuropsychiatric disorders (untreated depression or behavioral problems).
  • * Recent history of drugs or alcohol abuse.
  • * Primary generalized epilepsy (Lennox Gastaut, drop attacks).
  • * Post infectious epilepsy (i.e., post-herpetic).
  • * Previous corpus callosotomy.
  • * Significant structural brain abnormalities.
  • * Unable or unwilling to maintain drug dosage for 3 months post treatment.
  • * Pregnant or not practicing birth control method acceptable to the principal investigator.
  • * History of claustrophobia.
  • * Known allergic reaction and/or hypersensitivity to IV dye and/or IV contrasting agent(s).
  • * MRI contraindicated implanted metal or medical device.
  • * Uncontrolled hypertension or other comorbid conditions
  • * Skull Density Ratio (SDR) \<0.4.
  • * IQ score of \<70 on the Wechsler Advanced Clinical Solutions - Test of Premorbid Functioning (TOPF), a measure conducted as part of baseline neuropsychological assessment.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of North Carolina, Chapel Hill,

Vibhor Krishna, MD SM, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

2025-05