A Phase 1 interventional study of Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) in Anxiety and Medication-refractory Focal-onset Epilepsy, sponsored by Ohio State University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Ohio State University · Phase 1, Interventional, and Other
The purpose of this study is to evaluate the feasibility, safety, and effects on anxiety of high intensity focused ultrasound ablation (FUSA) in patients suffering from treatment-refractory focal epilepsy and anxiety. FUSA is a non-invasive neurosurgical procedure that uses ultrasound waves, sent directly through the scalp and skull, to precisely target small abnormal areas of the brain. For this study, the targeted area of the brain is the anterior nucleus of the thalamus. This brain region may cause seizures and may also be involved in anxiety. The study will test if FUSA is safe and tolerated, and if it reduces anxiety and brain response to threat in patients with anxiety receiving the procedure for partial-onset epilepsy that is resistant to medications.
This is an open-label, Phase 1 prospective intervention study. Ten (10) adults with refractory, partial-onset epilepsy with moderate-severe anxiety and able to provide informed consent will be enrolled.
Patients, eligible for Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) of the anterior nucleus of the thalamus (ATN) for treatment-refractory epilepsy and who present moderate-severe anxiety will be enrolled. In addition to the diagnosis of medically refractory epilepsy, patients will need to present moderate to severe anxiety (as measured by the Hamilton Anxiety Rating Scale, HAM-A; HAMA score > 17) and other protocol specific inclusion and exclusion criteria.
Medication-refractory partial or focal-onset epilepsy is often associated with enhanced fear behaviors and clinical anxiety. Exaggerated amygdala reactivity to threat is a cardinal neural phenotype of fear and anxiety disorders. The study will determine if MRgFUSA-ATN is feasible and safe and its effects on anxiety, using neuroimaging and neurological, neurocognitive/neuropsychological, psychiatric assessments before, and 1 day, 1 week, 1 month, 3 months, 6 months and 12 months post MRgFUSA.
Feasibility is defined as the ability to create the desired lesion within the anterior nucleus of the thalamus and perform fMRI to measure threat reactivity.
Safety will be measured by recording and analyzing any adverse effects that may occur from before surgery through 12 months following the surgery. These will include any new onset of neurological deficits, or performance deterioration on neuropsychological testing.
Effects on anxiety will be measured using amygdala reactivity to threat by fMRI and patient- and clinician-reported measures of anxiety symptoms before and after MRgFUSA-ATN up to 12 months.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 2 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
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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).
Exclusion Criteria:
Unilateral Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) of the anterior nucleus of the thalamus (ATN)
Device: Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA)
Unilateral Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) of the anterior nucleus of the thalamus (ATN)
Incidence of Treatment-Emergent Adverse Events
Safety will be determined by an evaluation of the incidence and severity of MRgFUSA-ATN and other research procedures related adverse events from the 1st study visit through the 12-month post-treatment time point. Post-procedural imaging will be evaluated for evidence of swelling, hemorrhage, and the evolution of the ATN lesion. Emergence of complications will be monitored by neurological examination at day 1, day 7, month 1, month 3, month 6 and month 12 post-procedure. A comprehensive battery of neuropsychological assessments will be conducted by board-certified neuropsychologists at study screening, 3-month and 12-month postoperative time points. All events that are not procedure related will also be captured and recorded.
Time frame: 12 months
Target
Feasibility will be determined by ability to create the desired lesion within the anterior nucleus of the thalamus as assessed by neuroimaging
Time frame: 1 month
Change in Anxiety symptoms
Change in anxiety symptoms will be measured using clinician-administered HAM-A scale before the procedure and at various time points after the procedure. HAM-A is the scale of reference used in clinical trials to rate the severity of symptoms of anxiety in patients. It will be collected before and after the procedure at day 1, 7, months 1, 3, 6 and 12 to determine any effect and its change overtime.
Time frame: 12 months
Effect on Threat Reactivity
Change in Threat reactivity measured by fMRI task just before and after MRgFUSA
Time frame: 1 day
Change in seizure frequency
Change in seizure frequency between before the procedure and after will be assessed by online or hard copy seizure diary
Time frame: 12 months
Ability to perform the threat reactivity fMRI task just before and after MRgFUSA
Ability to perform the fMRI task before and after MRgFUSA will be assessed by recording any delay or inability to perform the assessment
Time frame: 4 years
Change in self-reported anxiety symptoms
Change in Self-report symptoms of anxiety using the Beck Anxiety Inventory from before the procedure up to 12 months post-procedure.
Time frame: 12 months
Change in self-reported anxiety symptoms
Change in Self-report symptoms on the Anxiety, Depression, Stress scale from before the procedure up to 12 months post-procedure
Time frame: 12 months
Change in quality of life
Change in quality of life between before and after the procedure will be measured using the Quality of Life in Epilepsy Inventory before and up to 12 months after the procedure
Time frame: 12 months
Rate of Patient Accrual
Feasibility will be assessed by measuring the rate of patient accrual over the 4 years of the study
Time frame: 4 years
Plan to share: No — Data will be shared via the NIMH Data Archive, in compliance with NIH policy
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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