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

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ClinicalTrials.gov Identifier: NCT03417297
Recruitment Status : Available
First Posted : January 31, 2018
Last Update Posted : February 6, 2018
Focused Ultrasound Foundation
Information provided by (Responsible Party):
Vibhor Krishna, The Ohio State University

Brief Summary:
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 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.

Condition or disease Intervention/treatment
Partial Seizures With Secondary Generalization Device: high intensity focused ultrasound

Detailed Description:

This is a open-label prospective intervention study. Ten (10) adults with refractory, partial-onset epilepsy with secondary generalization and able to provide informed consent will be enrolled. In addition to the diagnosis of medically refractory epilepsy, these patients will need to meet protocol specific inclusion and exclusion criteria. These adults will be screened from the patients being cared for by the epilepsy program at The Ohio State University or referred from elsewhere for enrollment in the study. Initially, 3 participants will be enrolled and followed for 3 months to assess the safety of study intervention. Pending review by the Data and Safety Monitoring Committee (DSMC), an additional 7 participants will be enrolled.

This pilot study is being conducted to test this feasibility of this device in order to confirm the design and operating specifications of the device including the ability to identify, and accurately ablate the target focus within the Anterior Nucleus.

Safety will be assessed by the absence of side effects, e.g. new onset of neurological deficits, performance deterioration on neuropsychological testing. Feasibility is defined as the ability to create the desired lesion within the anterior nucleus.

Seizure frequency data will be collected by seizure diary. Quality of life will be measured by the Quality of Life in Epilepsy Inventory -31. Imaging analysis will include study of changes in resting state functional connectivity (assessed by fMRI), as well as in structural (assessed by volumetric T1 and T2 weighted imaging) and microstructural (assessed by diffusion tensor imaging) brain anatomy.

Study Type : Expanded Access
Official Title: 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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Device: high intensity focused ultrasound
    high intensity focused ultrasound
    Other Name: ExAblate Model 4000 Type-1 focused ultrasound

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion 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.
  • 18-65 years of age, inclusive.
  • Previous seizure work-up within 12 months of enrollment date to include:

    • Home EEG or EMU video EEG or intracranial EEG.
    • Baseline neuropsychological assessment, which includes the Wechsler Advanced Clinical Solutions - Test of Premorbid Functioning (TOPF). Subjects obtaining an IQ score of ≥70 on the TOPF will be included.
    • High definition MRI imaging/PET imaging.

Exclusion Criteria:

  • Low seizure frequency (<3 seizures/month).
  • Previous vagal nerve stimulator.
  • Severe untreated neuropsychiatric disorders (untreated depression or behavioral problems).
  • Recent history of drugs or alcohol abuse.
  • Generalized epilepsy (Lennox Gastaut, drop attacks).
  • Post infectious epilepsy (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).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417297

Contact: Carson R Reider, PhD 614.293.9274 carson.reider@osumc.edu
Contact: Angela S Emerson, MPH 614.685.3141 angela.emerson@osumc.edu

Sponsors and Collaborators
Vibhor Krishna
Focused Ultrasound Foundation

Responsible Party: Vibhor Krishna, Assistant Clinical Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT03417297     History of Changes
Other Study ID Numbers: 2017H0446
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms