The Impact of Focused Ultrasound Thalamotomy of the Anterior Nucleus for Focal-Onset Epilepsy on Anxiety

Running, not enrolling · Phase 1

Conditions studied: Anxiety, Medication-refractory Focal-onset Epilepsy

In brief

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.

Key facts

Study ID

NCT05032105

Run by

Ohio State University

People needed

2

Starts

2024-06-04

Expected to finish

2027-12-31

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Disabling, medically refractory epilepsy (≥2 anti-epileptic drug failures).
• Focal onset seizures with secondary generalization; with or without primary generalized seizures.
• Previous seizure work-up within 12 months of enrollment date to include:
• 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).
• Willing to maintain seizure diary (3 months before \& 3 months after).
• Involved care provider.
• Written informed consent to participate.
• Ability to comply with all testing, follow-ups, and study appointments and protocols.

You may not qualify if…

• Low seizure frequency (<3 seizures/month).
• Generalized epilepsy (Lennox Gastaut, drop attacks).
• Post infectious epilepsy (post herpetic).
• Unable or unwilling to maintain anti-epilepsy drug dosage for 3 months post treatment.
• Active (current in past 12 months), uncontrolled DSM-5 psychiatric disorder, except for anxiety disorders.
• Recent (past 12 months) history of drugs or alcohol abuse as evidenced by diagnosis of Substance Use Disorder.
• Active suicidal ideation current and past 30 days.
• Clinically significant neurological disorder, except for epilepsy.
• Presence of any neurodegenerative disease suspected on neurological examination. These include but are not limited to: Multisystem atrophy; Progressive supranuclear palsy; Dementia with Lewy bodies; Alzheimer's disease; Parkinson's disease.
• Cerebrovascular disease (multiple CVA or CVA within six months).
• Significant structural brain abnormalities.
• Surgical lesion identifiable on imaging.
• Symptoms and signs of increased intracranial pressure.
• Patients with any types of brain tumors, including metastases.
• Previous vagal nerve stimulator.
• Previous corpus callosotomy.
• Patients who have had deep brain stimulation.
• Prior stereotactic ablation.
• Positive urine drug screen at study entry or any follow-up testing session. For cannabis, exclusion includes positive drug screen with self-report of cannabis use in the past 48 hours.
• Known allergic reaction and/or hypersensitivity to IV dye and/or IV contrasting agent(s).
• Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
• History of claustrophobia.
• Unstable cardiac status including: Unstable angina pectoris on medication; documented myocardial infarction within last 40 days to protocol entry; Congestive heart failure; Severe hypertension (diastolic BP> 100 on medication).
• Patients receiving dialysis;
• Patients with risk factors for intraoperative or postoperative bleeding: Platelet count less than 100,000 per cubic millimeter; PT> 14PTT > 40; INR > 1.43.

Where it is running

• The Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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