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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 : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
InSightec

Tracking Information
First Submitted Date  ICMJE June 14, 2016
First Posted Date  ICMJE June 17, 2016
Last Update Posted Date May 24, 2019
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
Severity of device and procedure related complications [ Time Frame: At the time of ExAblate Transcranial procedure ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02804230 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MR-Guided Focused Ultrasound in the Treatment of Subcortical Lesional Epilepsy
Official Title  ICMJE A Feasibility Study to Evaluate Safety and Initial Effectiveness of MR-Guided Focused Ultrasound Ablation Therapy in the Treatment of Subcortical Lesional Epilepsy
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy, Unspecified, Refractory (Medically)
Intervention  ICMJE Device: MRgFUS Ablation of Epileptic Foci
MR-Guided Focused Ultrasound
Other Names:
  • MRgFUS
  • FUS
  • Focused Ultrasound
  • MR-Guided Focused Ultrasound
Study Arms  ICMJE Experimental: MRgFUS Ablation of Epileptic Foci
MR-Guided Focused Ultrasound
Intervention: Device: MRgFUS Ablation of Epileptic Foci
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 14, 2016)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02804230
Other Study ID Numbers  ICMJE EP001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party InSightec
Study Sponsor  ICMJE InSightec
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nathan Fountain, MD University of Virginia
PRS Account InSightec
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP