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Procedure

Focused Ultrasound Thalamotomy for Epilepsy and Anxiety

Phase 1
Waitlist Available
Led By Vibhor Krishna, MD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 3 seizures/month on average within 3 months of enrollment
Moderate-severe anxiety as measured by the Hamilton Anxiety Rating Scale (HAM-A) score > 17
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Study Summary

This trial will study whether a non-invasive brain procedure can help people with epilepsy who haven't responded to medication, and whether it can also reduce anxiety.

Who is the study for?
This trial is for adults with focal epilepsy and moderate to severe anxiety who haven't responded well to treatments. They must have had a stable medication dose for 3 months, experience at least 3 seizures per month, and be able to follow the study's procedures. People can't join if they have low seizure frequency, certain other neurological conditions, recent substance abuse, or are pregnant.Check my eligibility
What is being tested?
The trial tests MR-guided Focused Ultrasound Ablation (MRgFUSA) on the anterior nucleus of the thalamus in patients with treatment-resistant focal epilepsy and anxiety. It aims to see if this non-invasive procedure is safe and reduces both seizures and anxiety symptoms.See study design
What are the potential side effects?
Potential side effects may include discomfort from staying still during treatment (up to 4 hours), risks associated with MRI scans like reactions to IV dye or contrasting agents, and possible unknown risks since it's a new application of this technology.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had 3 or more seizures a month in the last 3 months.
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I have moderate to severe anxiety.
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My epilepsy hasn't improved despite trying at least two different medications.
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I experience seizures that start in one area and can spread.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Anxiety symptoms
Effect on Threat Reactivity
Incidence of Treatment-Emergent Adverse Events
+1 more
Secondary outcome measures
Ability to perform the threat reactivity fMRI task just before and after MRgFUSA
Change in quality of life
Change in seizure frequency
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Unilateral Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) of the anterior nucleus of the thalamus (ATN)

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
829 Previous Clinical Trials
505,733 Total Patients Enrolled
14 Trials studying Anxiety
2,656 Patients Enrolled for Anxiety
Vibhor Krishna, MDPrincipal InvestigatorOhio State University
3 Previous Clinical Trials
490 Total Patients Enrolled
Timothy Lucas, MDPrincipal InvestigatorOhio State University

Media Library

Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05032105 — Phase 1
Anxiety Research Study Groups: Intervention
Anxiety Clinical Trial 2023: Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) Highlights & Side Effects. Trial Name: NCT05032105 — Phase 1
Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05032105 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What outcomes is the research hoping to attain?

"This 12-month study seeks to measure the impact of its intervention on patient anxiety. Secondary objectives include gauging quality of life changes, evaluating patients' ability to perform an fMRI task before and after a procedure, and assessing modifications in self-reported stress levels over time."

Answered by AI

Is the patient demographic for this trial limited to individuals aged 55 or younger?

"The age limits for this clinical trial are 18 to 65 years. There is a total of 248 and 589 studies available, respectively, concerning those below and above the specified age range."

Answered by AI

Is it still possible to join the experiment as a participant?

"Clinicaltrials.gov indicates that this research is no longer open to new applicants, having first been posted on December 1st 2022 and last updated October 26th 2022. However, 857 other trials are presently recruiting participants."

Answered by AI

Do I fulfill the criteria to enter into this research program?

"With this pharmaceutical trial, 10 adults aged 18 - 65 are being admitted to participate. Furthermore, these individuals should be able to provide a seizure diary for 3 months before and after the study as well their care provider's involvement; have focal onset seizures with or without primary generalization that occur at least three times per month in the last quarter prior to enrolment; must demonstrate medically refractory epilepsy due to two anti-epileptic drug failures; maintain an unchanging dosage of medications (anti-epileptics and psychotropics included) over the course of 3 months leading up to enrollment date; and display moderate-severe anxiety"

Answered by AI

Has the FDA endorsed Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) for implementation?

"MRgFUSA receives a score of 1 on the scale, signifying that its safety and efficacy have been established to some degree in initial studies."

Answered by AI
Recent research and studies
~7 spots leftby Dec 2025