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NCT05032105 · ClinicalTrials.gov registry record · Phase 1
The Impact of Focused Ultrasound Thalamotomy of the Anterior Nucleus for Focal-Onset Epilepsy on Anxiety
A Phase 1 study of Anxiety and Medication-refractory Focal-onset Epilepsy, sponsored by Ohio State University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05032105: Recruiting Phase 1 study of Anxiety and Medication-refractory Focal-onset Epilepsy, sponsored by Ohio State University.
NCT05032105 is a Phase 1 study of Anxiety and Medication-refractory Focal-onset Epilepsy that is actively recruiting participants, run by Ohio State University. The registered enrollment target is 10 participants, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05032105, a Phase 1 study of Anxiety and Medication-refractory Focal-onset Epilepsy, is actively recruiting participants, sponsored by Ohio State University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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
Conditions Studied
Interventions
- DEVICE Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA)
Study Locations (1)
Ohio
- The Ohio State University - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2024-06-04 |
| Est. Completion | 2025-12 |
| Phase | Phase 1 |
What NCT05032105 shows while recruiting
NCT05032105 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Anxiety appearing as the primary indexed condition, and to 1 intervention - of which Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) is the first listed.
NCT05032105 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05032105 about?
NCT05032105 is a clinical study titled "The Impact of Focused Ultrasound Thalamotomy of the Anterior Nucleus for Focal-Onset Epilepsy on Anxiety". 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 di...
What is the current status of trial NCT05032105?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2024-06-04. Estimated completion is 2025-12.
What conditions does trial NCT05032105 study?
This clinical trial studies the following conditions: Anxiety, Medication-refractory Focal-onset Epilepsy.
What interventions are being tested in trial NCT05032105?
The interventions under investigation include: Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) (DEVICE).
Who is sponsoring clinical trial NCT05032105?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05032105 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05032105's enrollment target sits among peer trials
10 355th of 364 higher than 6 of 364 other Anxiety trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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