ACTIVE_NOT_RECRUITING

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

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Conditions

Partial Seizures With Secondary GeneralizationFocal Epilepsy With Secondary Generalization

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to assess the safety and feasibility of unilateral focused ultrasound thalamotomy in adults with focal onset 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 seizures. Safety will be measured by recording and analyzing the frequency of side effects throughout participation. Feasibility will be measured by the ability to create a lesion in the anterior nucleus.

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

Quick Facts

Study Start:2018-04-24
Study Completion:2028-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03417297

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Medically refractory epilepsy (≥2 antiepileptic drug failures) deemed disabling by the patient and study investigators.
  2. * Focal seizures with secondary generalization; with or without primary generalized seizures.
  3. * ≥ 3 seizures/month on average based on seizure diary of patient's preferred format during the three months prior to enrollment.
  4. * Stable prescribed epilepsy medication dosages, including stopping or starting medication, for 3 months before enrollment.
  5. * Anterior Nucleus (AN) identifiable on MRI (structural T1 and T2 images).
  6. * Willing to maintain seizure diary (3 months before \& 3 months after the study treatment).
  7. * Involved caregiver such as a spouse, family member, or family friend willing to provide reliable care during the study participation.
  8. * Ability to provide written informed consent to participate.
  9. * Previous seizure work-up to include:
  10. 1. Home EEG, Epilepsy Monitoring Unit (EMU) video EEG, or intracranial EEG.
  11. 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.
  12. 3. High-definition MRI imaging/Position emission tomography (PET) imaging.
  1. * Have on average less than 3 seizures a month.
  2. * Have an indwelling vagal nerve stimulator.
  3. * Have severe untreated neuropsychiatric disorders (e.g., untreated depression or behavioral problems).
  4. * History of drug or alcohol abuse in the last 12 months.
  5. * Presence of primary generalized epilepsy (e.g., Lennox Gastaut, drop attacks).
  6. * Presence of post-infectious epilepsy (i.e., epilepsy from post-herpetic encephalitis).
  7. * Previous corpus callosotomy (surgery to cut the fibers, called the corpus callosum, that separate each half of the brain).
  8. * Significant structural brain abnormalities.
  9. * Unable or unwilling to maintain your current anti-seizure drug dosage for 3 months post-treatment.
  10. * Pregnant or not practicing birth control methods.
  11. * History of claustrophobia (fear of closed spaces).
  12. * Presence of an MRI contraindicated implanted metal or medical device (e.g., pacemaker, metallic joints, or insulin pump).
  13. * Uncontrolled hypertension or other comorbid conditions (e.g., uncontrolled heart or lung disease).
  14. * Skull Density Ratio (SDR) \<0.4.
  15. * IQ score of \<70 on the Wechsler Advanced Clinical Solutions - Test of Premorbid Functioning (TOPF), a measure conducted as part of baseline neuropsychological assessment.

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-04-24
Study Completion Date2028-05

Study Record Updates

Study Start Date2018-04-24
Study Completion Date2028-05

Terms related to this study

Additional Relevant MeSH Terms

  • Partial Seizures With Secondary Generalization
  • Focal Epilepsy With Secondary Generalization