EpilepsyNCT02804230
MR-Guided Focused Ultrasound in the Treatment of Focal Epilepsy (EP001)
A study testing Neuro Ablation - Functional in people with Epilepsy, run by InSightec at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the feasibility, safety, and initial effectiveness of Exablate thermal ablation of a 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 focus… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Neuro Ablation - Functional
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Jun 2016to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are able and willing to give consent and able to attend all study visits.
- 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 focal seizures with or without secondary generalization. Subjects should have evidence suggesting the focus within the periventricular white matter, basal ganglia, thalamus, hypothalamus, or mesial temporal lobe has been previously determined as 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 lesional epilepsy which may include: Hypothalamic hamartoma, Periventricular nodular hetereotopia, Dysembryoplastic neuroepithelial tumor (DNET), Cortical dysplasia, Tuberous sclerosis, Focal cortical gliosis, or Predominately unilateral Mesial Temporal Lobe Epilepsy (MTLE).
Who cannot join
- Patients with unstable cardiac status that would increase anesthetic risk including: unstable angina pectoris on medication, documented myocardial infarction within six months of protocol entry, congestive heart failure requiring medication (other than diuretic), anti-arrhythmic drug use.
- Patients exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV as manifested by one (or more) of the following occurring within a 12 month period:
- Recurrent substance use resulting in a failure to fulfill major role obligations at work, school, or home (such as repeated absences or poor work performance related to substance use; substance-related absences, suspensions, or expulsions from school; or neglect of children or household, Recurrent substance use in situations in which it is physically hazardous (such as driving an automobile or operating a machine when impaired by substance use), Recurrent substance-related legal problems (such as arrests for substance related disorderly conduct), Continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance (for example, arguments with spouse about consequences of intoxication and physical fights).
- Severe hypertension (diastolic BP > 100 on medication) measured at intake interview or on Treatment Day.
- Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
- Known intolerance or allergies to the MRI contrast agent (i.e. Gadavist) including advanced kidney disease.
Show all 20Show fewer
- Known or suspected sensitivity to perfluetren (Definity®). Severely impaired renal function (estimated glomerular filtration rate < 45ml/min/1.73 m2) or receiving dialysis.
- History of abnormal bleeding and/or coagulopathy. Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk of hemorrage (e.g. Avastin) within one month of focused ultrasound procedure; or, unable or unwilling to stop anticoagulant for the purposed of focused ultrasound procedure.
- Active or suspected acute or chronic uncontrolled infection. History of intracranial hemorrhage. Cerebrovascular disease (multiple CVA or CVA within 6 months). 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).
- Symptoms and signs of increased intracranial pressure (e.g. headache, nausea, vomiting, lethargy, and papilledema).
- Are participating or have participated in another clinical trial in the last 30 days.
- Presence of any other neurodegenerative disease. Present of cognitive impairment severe enough to be unable to understand and consent for the study, or understand the procedures.
- History of immunocompromise, including patient who is HIV positive. Known life-threatening systemic disease. Patient with current or a prior history of current suicidal ideation or previous suicide attempt within the past year.
- Patients with risk factors for intraoperative or postoperative bleeding (platelet count less than 100,000 per cubic millimeter, PT > 14, PTT > 36 or INR > 1.3) or a documented coagulopathy.
- Patients with malignant brain tumors. Any illness that in the investigator's opinion precludes participation in this study.
- Pregnancy or lactation. Legal incapacity or limited legal capacity. Patients with a known history of psychogenic non-epileptic spells in the last three years.
- Patients with a vagal nerve stimulator (that is not MRI-safe and/or MRI compatible), deep brain stimulator, other implanted electronic device, or prior radiofrequency lesion techniques.
- Patient with cardiopulmonary or vascular illness that would complicate anesthesia.
- Patients who are unwilling to undergo general anesthesia. Patients with lesions in the brainstem or cerebellum. Patients with symptomatic generalized epilepsy. Patients with only simple partial seizures. Patients who have had convulsive status epilepticus within 12 months prior to baseline.
- Patients with a prior diagnosis of psychogenic/non-epileptic seizures within the last 5 years.
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Stacy Thompson, 434-982-4315, SRC2H@hscmail.mcc.virginia.edu
Nathan Fountain, MD
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Eric Penner, epenner@kumc.edu
Michael Kinsman, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Matt Hoplin, 507-422-2121, hoplin.matthew@mayo.edu
Jamie Van Gompel, MD
- Recruiting
Stanford University
Stanford, California, 94305
Jordan Seliger, 650-460-9260, jseliger@stanford.edu
Robert Fisher, MD
About this study
Official title: A Feasibility Study to Evaluate Safety and Initial Effectiveness of MR-Guided Focused Ultrasound Ablation Therapy in the Treatment of Focal Epilepsy
The purpose of this study is to evaluate the feasibility, safety, and initial effectiveness of Exablate thermal ablation of a 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 focus 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.
Read the detailed description
The purpose of this study is to evaluate the feasibility, safety, and initial effectiveness of Exablate thermal ablation of a 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:
- MRgFUS treatment of focal epilepsy is feasible and safe, with a low risk of adverse effects as evaluated during the follow-up period.
- Exablate treatment of foci in patients with focal epilepsy reduces the seizure frequency.
- Conditions
- Epilepsy
- Being tested
- Neuro Ablation - Functional
- Keywords
- Mr-Guided Focused Ultrasound
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro Ablation - FunctionalDevice
Also called Focused Ultrasound, MRgFUS, FUS
MR-Guided Focused Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Exablate Neuro System Treatment | Experimental | MR-Guided Focused Ultrasound will be used to ablate epileptic foci up to 8 cm3 in size. Receives: Device: Neuro Ablation - Functional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of device and procedure related complications
Measured: At the time of Exablate transcranial procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study start7 Jun 2016
- Primary completion23 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by InSightecThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, open-label, single-cohort study with no control group to evaluate initial safety, feasibility, and effectiveness of the Exablate 4000 Type 1 or 1.1 System.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804230
- Sponsor's protocol ID
- EP001
- Status last verified
- Sep 2022
- First submitted
- 14 Jun 2016
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Evaluate Safety and Initial Effectiveness of MR-Guided Focused Ultrasound Ablation Therapy in the Treatment of Focal Epilepsy
- ClinicalTrials.gov ID
- NCT02804230
- Acronym / sponsor ID
- EP001
- Conditions
- Epilepsy
- Keywords
- Mr-Guided Focused Ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- 7 Jun 2016 (actual)
- Primary completion
- 23 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the feasibility, safety, and initial effectiveness of Exablate thermal ablation of a 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 focus 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 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:
- MRgFUS treatment of focal epilepsy is feasible and safe, with a low risk of adverse effects as evaluated during the follow-up period.
- Exablate treatment of foci in patients with focal epilepsy reduces the seizure frequency.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, open-label, single-cohort study with no control group to evaluate initial safety, feasibility, and effectiveness of the Exablate 4000 Type 1 or 1.1 System.
| Arm | Type | Receives |
|---|---|---|
| Exablate Neuro System Treatment | Experimental | Device: Neuro Ablation - FunctionalMR-Guided Focused Ultrasound will be used to ablate epileptic foci up to 8 cm3 in size. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who are able and willing to give consent and able to attend all study visits.
- 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 focal seizures with or without secondary generalization. Subjects should have evidence suggesting the focus within the periventricular white matter, basal ganglia, thalamus, hypothalamus, or mesial temporal lobe has been previously determined as 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.
Key exclusion criteria (20 listed)
- Patients with unstable cardiac status that would increase anesthetic risk including: unstable angina pectoris on medication, documented myocardial infarction within six months of protocol entry, congestive heart failure requiring medication (other than diuretic), anti-arrhythmic drug use.
- Patients exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV as manifested by one (or more) of the following occurring within a 12 month period:
- Recurrent substance use resulting in a failure to fulfill major role obligations at work, school, or home (such as repeated absences or poor work performance related to substance use; substance-related absences, suspensions, or expulsions from school; or neglect of children or household, Recurrent substance use in situations in which it is physically hazardous (such as driving an automobile or operating a machine when impaired by substance use), Recurrent substance-related legal problems (such as arrests for substance related disorderly conduct), Continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance (for example, arguments with spouse about consequences of intoxication and physical fights).
- Severe hypertension (diastolic BP > 100 on medication) measured at intake interview or on Treatment Day.
- Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuro Ablation - FunctionalAlso: Focused Ultrasound, MRgFUS, FUSMR-Guided Focused Ultrasound | Device | Exablate Neuro System Treatment |
Primary outcome
Incidence and severity of device and procedure related complications
Time frame: At the time of Exablate transcranial procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuro Ablation - Functional in people with Epilepsy, run by InSightec at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadir Alikacem (+12146302000, nadira@insightec.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of device and procedure related complications (time frame: At the time of Exablate transcranial procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2022.