Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) for Medication-refractory Focal-onset Epilepsy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The Ohio State University, Columbus, OH
Medication-refractory Focal-onset Epilepsy+3 More
Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a non-invasive procedure can reduce anxiety in people with epilepsy.

See full description

Eligible Conditions

  • Medication-refractory Focal-onset Epilepsy
  • Anxiety

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Medication-refractory Focal-onset Epilepsy

Study Objectives

This trial is evaluating whether Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) will improve 4 primary outcomes and 5 secondary outcomes in patients with Medication-refractory Focal-onset Epilepsy. Measurement will happen over the course of 1 day.

1 day
Effect on Threat Reactivity
1 month
Target
12 months
Change in Anxiety symptoms
Change in quality of life
Change in seizure frequency
Change in self-reported anxiety symptoms
Incidence of Treatment-Emergent Adverse Events
4 years
Ability to perform the threat reactivity fMRI task just before and after MRgFUSA
Rate of Patient Accrual

Trial Safety

Safety Progress

1 of 3

Other trials for Medication-refractory Focal-onset Epilepsy

Trial Design

1 Treatment Group

Intervention
1 of 1
Experimental Treatment

This trial requires 10 total participants across 1 different treatment group

This trial involves a single treatment. Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Intervention
Device
Unilateral Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) of the anterior nucleus of the thalamus (ATN)

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4 years for reporting.

Who is running the study

Principal Investigator
K. L. P.
Kinh Luan Phan, Chair, Department of Psychiatry
Ohio State University

Closest Location

The Ohio State University - Columbus, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Willing to maintain seizure diary (3 months before & 3 months after).
Involved care provider.
Written informed consent to participate.
Disabling, medically refractory epilepsy (≥2 anti-epileptic drug failures).
Focal onset seizures with secondary generalization; with or without primary generalized seizures.
A. Home EEG or EMU video EEG or intracranial EEG. B. High definition MRI imaging/PET imaging. C. Baseline neuropsychological assessment, which includes the Wechsler Advanced Clinical Solutions - Test of Premorbid Functioning (TOPF).
≥ 3 seizures/month on average within 3 months of enrollment.
Stable medication (including anti-epileptic and psychotropic/psychoactive medications) dosage for 3 months before enrollment.
Moderate-severe anxiety as measured by the Hamilton Anxiety Rating Scale (HAM-A) score > 17.
Anterior Nucleus (AN) identifiable on MRI (structural T1 and T2 images).

Patient Q&A Section

Can aura be cured?

"Neither auras nor aura as a self-help phenomenon appear to be linked to a specific physiological or biochemical phenomenon, but auras may be associated with a reduced ability to self-monitor and may be an index of risk." - Anonymous Online Contributor

Unverified Answer

What is aura?

"About 0.6% of those who seek specialist care experience a transient, non-diagnosable mental illness. If the transient aura represents a 'false' diagnosis, this may lead to more severe disorders." - Anonymous Online Contributor

Unverified Answer

What are common treatments for aura?

"Generally, the only treatment the author and his team have used is antiepileptic drug administration, usually with carbamazepine or gaboxadol, sometimes supplemented with gaboxadol in the emergency department." - Anonymous Online Contributor

Unverified Answer

What are the signs of aura?

"Aura is an objective clinical sign of focal brainstem or cortical seizure activity: it is manifested by ictal symptoms and/or by behavioral, perceptual, emotional or autonomic symptoms." - Anonymous Online Contributor

Unverified Answer

How many people get aura a year in the United States?

"About 9% of women, and 22% of men, have at least 3 episodes of aura per year. About 28% of women, and 45% of men, have at least 1 aura per month. Nearly 15% of US adults have aura. Although rarer, women are more likely than men to have migraines in conjunction with aura." - Anonymous Online Contributor

Unverified Answer

What causes aura?

"There is little evidence support for a single cause, or for any one explanation of the common aura concept, and it is still unclear why some people experience an aura during headaches, when others don't. There has been some suggestion that there may be common underlying causes, but this is not sufficient evidence to infer they can explain everything." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of magnetic resonance imaging-guided focused ultrasound ablation (mrgfusa)?

"Recent findings, serious side effects occurred in 25% of patients who underwent the MRgfusa procedure. For the same procedure with ultrasonography guidance, serious side effects occurred in 11% of patients. Although MRgfusa can be performed using a conventional US probe, MRgfusa guided by MR imaging is recommended to be performed using a MR probe." - Anonymous Online Contributor

Unverified Answer

How does magnetic resonance imaging-guided focused ultrasound ablation (mrgfusa) work?

"The application of high-intensity focused ultrasound under the guidance of 3-dimensional magnetic resonance imaging proved to be safe, effective and safe for small abdominal lesions." - Anonymous Online Contributor

Unverified Answer

Does magnetic resonance imaging-guided focused ultrasound ablation (mrgfusa) improve quality of life for those with aura?

"At 6 months follow-up, subjects with aura reported improvement in their HRQOL, as measured by the PHQ8. This improvement was maintained at 12 months. This treatment may help to improve quality of life for subjects with aura. In a recent study, findings is registered at ClinicalTrials.gov (NCT01090820)." - Anonymous Online Contributor

Unverified Answer

How serious can aura be?

"[Auras are not common, but often the patient feels that they are so serious] (M. M. Sørensen, 2004, B. J. Eriksson, 2007). [Power] can help you find clinical trials tailored to your condition, treatment, or location." - Anonymous Online Contributor

Unverified Answer

What is magnetic resonance imaging-guided focused ultrasound ablation (mrgfusa)?

"MRA guided focused ultrasound of the aetheric fat pad generates an instant ablation and improves lesion and perfusion parameters for 1-year follow up. MRA guided focused ultrasound is an effective, safe and promising technique for the thermal ablation of the aetheric-fat pad." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in magnetic resonance imaging-guided focused ultrasound ablation (mrgfusa) for therapeutic use?

"MRgfusa for therapeutic use provides high contrast vascular imaging for intra-ablation monitoring, high ablation rates with controlled overheating, and excellent safety profiles. MRgfusa offers a promising and safe therapeutic option for the treatment of small, benign vascular tumors that present at an inoperable stage or for which other treatment modalities are contraindicated. Further evaluation with large numbers of patients will elucidate the clinical potential of MRgfusa in therapeutic versus ablation mode." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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