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MR-Guided Focused Ultrasound in the Treatment of Subcortical Lesional Epilepsy (EP001)

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ClinicalTrials.gov Identifier: NCT02804230
Recruitment Status : Recruiting
First Posted : June 17, 2016
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
InSightec

Brief Summary:
The purpose of this study is to evaluate the feasibility, safety, and initial effectiveness of ExAblate thermal ablation of a subcortical focal epileptic target area in the brain of patients suffering from medication-refractory epilepsy, using the ExAblate transcranial system to produce multiple sonications targeted in the lesion of interest. The investigators will establish the feasibility and collect data to establish the basic safety of this type of treatment as the basis for later studies that will evaluate its full clinical efficacy.

Condition or disease Intervention/treatment Phase
Epilepsy, Unspecified, Refractory (Medically) Device: MRgFUS Ablation of Epileptic Foci Not Applicable

Detailed Description:

The purpose of this study is to evaluate the feasibility, safety, and initial effectiveness of ExAblate thermal ablation of a subcortical focal epileptic target area in the brain of patients suffering from medication-refractory epilepsy, using the ExAblate transcranial system to produce multiple sonications targeted in the lesion of interest. The Investigators will establish the feasibility and collect data to establish the basic safety of this type of treatment as the basis for later studies that will evaluate its full clinical efficacy.

The hypotheses tested are that:

  1. MRgFUS treatment of subcortical lesional epilepsy is feasible and safe, with a low risk of adverse effects as evaluated during the follow-up period.
  2. ExAblate treatment of subcortical lesions in patients with subcortical lesional epilepsy reduces the seizure frequency.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study to Evaluate Safety and Initial Effectiveness of MR-Guided Focused Ultrasound Ablation Therapy in the Treatment of Subcortical Lesional Epilepsy
Study Start Date : June 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Ultrasound

Arm Intervention/treatment
Experimental: MRgFUS Ablation of Epileptic Foci
MR-Guided Focused Ultrasound
Device: MRgFUS Ablation of Epileptic Foci
MR-Guided Focused Ultrasound
Other Names:
  • MRgFUS
  • FUS
  • Focused Ultrasound
  • MR-Guided Focused Ultrasound




Primary Outcome Measures :
  1. Severity of device and procedure related complications [ Time Frame: At the time of ExAblate Transcranial procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Seizure refractory to at least three standard antiepileptic medications at adequate doses, failed for lack of efficacy. This may include a rescue medication designated use as PRN.
  • A minimum of 3 seizures per month for 2 months by patient diary started at intake interview.
  • Subjects should have partial-onset seizures with or without secondary generalization.
  • Subjects should have evidence suggesting the target lesion is the source of seizures by standard clinical criteria including at least the description of seizures, physical examination, neuroimaging, and video EEG monitoring capturing at least one seizure.
  • Subjects must be taking 2 medications during the Baseline period and the dosage must be stable.
  • A diagnosis of intractable epilepsy secondary to a dysplastic subcortical lesion which would include: Hypothalamic hamartoma, Periventricular nodular hetereotopia, Dysembryoplastic neuroepithelial tumor (DNET), Cortical dysplasia, or Tuberous sclerosis

Exclusion Criteria:

  • Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
  • Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hrs of total table time.).
  • Patients with malignant brain tumors.
  • Patients with a known history of psychogenic non-epileptic spells in the last three years.
  • Patients with a vagal nerve stimulator, deep brain stimulator, other implanted electronic device, or prior radiofrequency lesion techniques.
  • Lesions in the brainstem or cerebellum.
  • Subjects with symptomatic generalized epilepsy.
  • Subjects with only simple partial seizures.
  • Subjects who have had convulsive status epilepticus within 12 months prior to baseline.
  • Subjects with a prior diagnosis of psychogenic/non-epileptic seizures within the last 5 years.
  • Subjects who are candidates for traditional open surgery or elect to receive traditional open surgery are excluded.

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): NCT02804230


Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Stacy Thompson    434-982-4315    SRC2H@hscmail.mcc.virginia.edu   
Principal Investigator: Nathan Fountain, MD         
Sponsors and Collaborators
InSightec
Investigators
Principal Investigator: Nathan Fountain, MD University of Virginia

Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT02804230     History of Changes
Other Study ID Numbers: EP001
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases