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Procedure

Focused Ultrasound Thalamotomy for Epilepsy and Anxiety

Phase 1
Recruiting
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
Must not have
Patients receiving dialysis
History of intracranial hemorrhage
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on dialysis.
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I have had bleeding in my brain before.
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I have a history of unusual bleeding or blood clotting issues.
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I have not had a stroke or multiple strokes in the last six months.
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My scalp has significant thinning and heals poorly.
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My cancer can be seen on scans.
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I have a neurological disorder, but it's not epilepsy.
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I have epilepsy that developed after a herpes infection.
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I have a neurodegenerative disease like Alzheimer's or Parkinson's.
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I have fewer than 3 seizures a month.
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I have been diagnosed with a type of generalized epilepsy.
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I am legally unable to make my own decisions.
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I have undergone stereotactic ablation before.
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I can stay still on my back for up to 4 hours.
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My blood tests show I might be at risk of bleeding during or after surgery.
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I cannot communicate with my doctor or their team.
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I have a stable heart condition without recent severe issues.
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I do not have any uncontrolled infections or life-threatening diseases.
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I experience symptoms like headaches or vision changes.
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I cannot or will not keep my epilepsy drug dose stable for 3 months after treatment.
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I have had surgery to sever the connection between my brain's hemispheres.
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I have a brain tumor, including any that have spread from elsewhere.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
866 Previous Clinical Trials
655,114 Total Patients Enrolled
14 Trials studying Anxiety
2,532 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
~5 spots leftby Dec 2025
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