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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 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.

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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.

Interventions

  • DEVICE Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA)

Study Locations (1)

Ohio

  • The Ohio State University - Columbus

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2024-06-04
Est. Completion 2025-12
Phase Phase 1

Sponsor

Ohio State University

552 total trials

What the Registry Record Tells You About NCT05032105

The ClinicalTrials.gov registry entry for NCT05032105 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (98% lower). The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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