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

Q: Who can participate in NCT05032105?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT05032105?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

.An Open-label Clinical Trial Evaluating the ExAblate Model 4000 Type-1 Focused Ultrasound Unilateral Thalamotomy for Patients with Treatment-refractory Focal Onset Epilepsy and Comorbid Anxiety.

The Impact of Focused Ultrasound Thalamotomy of the Anterior Nucleus for Focal-Onset Epilepsy on Anxiety (NCT05032105) is a Phase 1 interventional studying Anxiety and Medication-refractory Focal-onset Epilepsy, sponsored by Ohio State University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Anxiety, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 10 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form to participate. - Ability to comply with all testing, follow-ups, and study appointments and protocols. Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * History of abnormal bleeding and/or coagulopathy. * Receiving anticoagulant (e.g., Warfarin) or antiplatelet (e.g., aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk of hemorrhage (e.g., Avastin) within one month of scheduled focused ultrasound procedure. * History of intracranial hemorrhage. * Active or suspected, acute or chronic uncontrolled infection or known life-threatening systemic disease; * History of immunocompromised status, including patients who are HIV positive. * Subjects with remarkable atrophy and poor healing capacity of the scalp. * Evidence for calcifications that might interfere with treatment safety (per CT). * Skull Density Ratio (SDR) \<0.4. * Pregnancy or lactation or planning to become pregnant during the time-period of the study. * Any illness that in the investigators' opinion preclude participation in this study. * Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hrs of total table time); * IQ score of \<70 on the Wechsler Advanced Clinical Solutions - Test of Premorbid Functioning (TOPF), measured as part of screening neuropsychological assessment. * Presence of significant cognitive impairment as determined with a score ≤24 on the Mini Mental Status Examination (MMSE). * Patients unable to communicate with the investigator and staff. * Legal incapacity or limited legal capacity.

Treatments Being Tested

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)

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The Ohio State University

Columbus, Ohio, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05032105), the sponsor (Ohio State University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05032105 clinical trial studying?

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 tolerat… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05032105?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05032105?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05032105. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05032105. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.