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

• ClinicalTrials.gov Identifier: NCT02804230
• Recruitment Status: Recruiting
• First Posted: June 17, 2016
• Last Update Posted: May 24, 2019
• Sponsor: InSightec
• Information provided by (Responsible Party): InSightec

Tracking Information

• First Submitted Date: June 14, 2016
• First Posted Date: June 17, 2016
• Last Update Posted Date: May 24, 2019
• Study Start Date: June 2016
• Estimated Primary Completion Date: June 2022 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 14, 2016): Severity of device and procedure related complications [ Time Frame: At the time of ExAblate Transcranial procedure ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT02804230 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: MR-Guided Focused Ultrasound in the Treatment of Subcortical Lesional Epilepsy
• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Epilepsy, Unspecified, Refractory (Medically)

Intervention

Device: MRgFUS Ablation of Epileptic Foci

MR-Guided Focused Ultrasound

Other Names:

• MRgFUS
• FUS
• Focused Ultrasound
• MR-Guided Focused Ultrasound

Study Arms

Experimental: MRgFUS Ablation of Epileptic Foci

MR-Guided Focused Ultrasound

Intervention: Device: MRgFUS Ablation of Epileptic Foci

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 14, 2016): 10
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2022
• Estimated Primary Completion Date: June 2022 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02804230
• Other Study ID Numbers: EP001
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: InSightec
• Study Sponsor: InSightec
• Collaborators: Not Provided

Investigators

• Principal Investigator: Nathan Fountain, MD; University of Virginia

• PRS Account: InSightec
• Verification Date: May 2019