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NCT03417297 · ClinicalTrials.gov registry record · NA
A Pilot Study: Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy
A NA study of Partial Seizures With Secondary Generalization and Focal Epilepsy With Secondary Generalization, sponsored by University of North Carolina, Chapel Hill.
- Active
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT03417297: Active NA study of Partial Seizures With Secondary Generalization and Focal Epilepsy With Secondary Generalization, sponsored by University of North Carolina, Chapel Hill.
NCT03417297 is a NA study of Partial Seizures With Secondary Generalization and Focal Epilepsy With Secondary Generalization that is active but no longer recruiting, run by University of North Carolina, Chapel Hill. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03417297, a NA study of Partial Seizures With Secondary Generalization and Focal Epilepsy With Secondary Generalization, is active but no longer recruiting, sponsored by University of North Carolina, Chapel Hill.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to assess the safety and feasibility of unilateral focused ultrasound thalamotomy in adults with focal onset epilepsy whose medicines are not working well. The ExAblate (ExAblate) transcranial system is the name of the device that will be used to create and send ultrasound waves through the scalp and skull precisely to a small structure located in the center of the brain. This structure is known as the "Anterior Nucleus", and is an important region in the brain that may cause seizures. Safety will be measured by recording and analyzing the frequency of side effects throughout participation. Feasibility will be measured by the ability to create a lesion in the anterior nucleus.
Primary Outcome
Feasibility is defined as the ability to create the desired lesion within the anterior nucleus in 80% or more of participants.
Conditions Studied
Interventions
- DEVICE High Intensity Focused Ultrasound
Study Locations (1)
North Carolina
- University of North Carolina-Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-04-24 |
| Est. Completion | 2028-05 |
| Phase | NA |
What the registry record for NCT03417297 still lists
NCT03417297 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 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Partial Seizures With Secondary Generalization appearing as the primary indexed condition, and to 1 intervention - of which High Intensity Focused Ultrasound is the first listed.
NCT03417297 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03417297 about?
NCT03417297 is a clinical study titled "A Pilot Study: Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy". The purpose of this study is to assess the safety and feasibility of unilateral focused ultrasound thalamotomy in adults with focal onset epilepsy whose medicines are not working well. The ExAblate (ExAblate) transcranial system is the name of the device that will be used to create and send ultrasou...
What is the current status of trial NCT03417297?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2018-04-24. Estimated completion is 2028-05.
What conditions does trial NCT03417297 study?
This clinical trial studies the following conditions: Partial Seizures With Secondary Generalization, Focal Epilepsy With Secondary Generalization.
What interventions are being tested in trial NCT03417297?
The interventions under investigation include: High Intensity Focused Ultrasound (DEVICE).
Who is sponsoring clinical trial NCT03417297?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03417297 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03417297's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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