Partial Seizures With Secondary GeneralizationNCT03417297

A Pilot Study: Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy

A study testing High Intensity Focused Ultrasound in people with Partial Seizures With Secondary Generalization and Focal Epilepsy With Secondary Generalization, run by University of North Carolina, Chapel Hill at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Partial Seizures With Secondary Generalization, Focal Epilepsy With Secondary Generalization
What is being tested?: High Intensity Focused Ultrasound
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 24 Apr 2018to May 2028
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Medically refractory epilepsy (≥2 antiepileptic drug failures) deemed disabling by the patient and study investigators.
Focal seizures with secondary generalization; with or without primary generalized seizures.
≥ 3 seizures/month on average based on seizure diary of patient's preferred format during the three months prior to enrollment.
Stable prescribed epilepsy medication dosages, including stopping or starting medication, for 3 months before enrollment.
Anterior Nucleus (AN) identifiable on MRI (structural T1 and T2 images).
Willing to maintain seizure diary (3 months before \& 3 months after the study treatment).

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Involved caregiver such as a spouse, family member, or family friend willing to provide reliable care during the study participation.
Ability to provide written informed consent to participate.
Previous seizure work-up to include:
Home EEG, Epilepsy Monitoring Unit (EMU) video EEG, or intracranial EEG.
Baseline neuropsychological assessment, which includes the Wechsler Advanced Clinical Solutions - Test of Premorbid Functioning (TOPF). Participants obtaining an Intelligence Quotient (IQ) score of ≥70 on the TOPF will be included.
High-definition MRI imaging/Position emission tomography (PET) imaging.

Who cannot join

Have on average less than 3 seizures a month.
Have an indwelling vagal nerve stimulator.
Have severe untreated neuropsychiatric disorders (e.g., untreated depression or behavioral problems).
History of drug or alcohol abuse in the last 12 months.
Presence of primary generalized epilepsy (e.g., Lennox Gastaut, drop attacks).
Presence of post-infectious epilepsy (i.e., epilepsy from post-herpetic encephalitis).

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Previous corpus callosotomy (surgery to cut the fibers, called the corpus callosum, that separate each half of the brain).
Significant structural brain abnormalities.
Unable or unwilling to maintain your current anti-seizure drug dosage for 3 months post-treatment.
Pregnant or not practicing birth control methods.
History of claustrophobia (fear of closed spaces).
Presence of an MRI contraindicated implanted metal or medical device (e.g., pacemaker, metallic joints, or insulin pump).
Uncontrolled hypertension or other comorbid conditions (e.g., uncontrolled heart or lung disease).
Skull Density Ratio (SDR) <0.4.
IQ score of <70 on the Wechsler Advanced Clinical Solutions - Test of Premorbid Functioning (TOPF), a measure conducted as part of baseline neuropsychological assessment.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: A Pilot Open-label Clinical Trial Evaluating the ExAblate Model 4000 Type-1 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 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.

Read the detailed description

This is an open-label prospective intervention study. Ten (10) adults with refractory, focal epilepsy with secondary generalization and able to provide informed consent will undergo focused ultrasound (FUS) thalamotomy. In addition to the diagnosis of medically refractory epilepsy, these patients will need to meet protocol specific inclusion and exclusion criteria. These adults will be screened from the patients being cared for by the epilepsy program at the University of North Carolina at Chapel Hill or referred from elsewhere for enrollment in the study. Initially, 3 participants will be enrolled and followed for 3 months to assess the safety of study intervention. Pending review by the Data and Safety Monitoring Committee (DSMC) and the US Food and Drug Administration (FDA), additional subjects will be enrolled.

This pilot study is being conducted to test the feasibility of this device in order to confirm the design and operating specifications of the device including the ability to identify and accurately ablate the target focus within the Anterior Nucleus.

Safety will be assessed by the frequency of side effects, e.g., new onset of neurological deficits, performance deterioration on neuropsychological testing. Feasibility is defined as the ability to create the desired lesion within the anterior nucleus.

Seizure frequency data will be collected by seizure questionnaire. Quality of life will be measured by the Quality of Life in Epilepsy Inventory (QOLIE-31). Imaging analysis will include a comparison of pre- and post-intervention imaging to identify brain networks associated with clinical outcomes and determine changes in resting-state functional connectivity (assessed by fMRI), as well as in structural (assessed by volumetric T1 and T2 weighted imaging) and microstructural (assessed by diffusion tensor imaging) brain anatomy.

Subject satisfaction with FUS thalamotomy will be assessed by the Epilepsy Surgery Satisfaction Questionnaire (ESSQ-19).

Conditions: Partial Seizures With Secondary Generalization, Focal Epilepsy With Secondary Generalization
Being tested: High Intensity Focused Ultrasound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High Intensity Focused UltrasoundDevice
Also called ExAblate Model 4000 Type-1 Focused Ultrasound
Participants will undergo high intensity focused ultrasound surgery utilizing magnetic resonance (MR) imaging guidance using a 3 Tesla scanner.

Study groups in NCT03417297
Study group	Role	What they receive
high intensity focused ultrasound	Experimental	Initially, 3 patients will be enrolled and followed for 3 months to assess the safety of study intervention which is unilateral focused ultrasound thalamotomy (anterior nucleus). These data will be reviewed by the Data and Safety Monitoring Committee (DSMC) and the FDA. If approval is granted by the DSMC and FDA, then additional subjects will be enrolled. Receives: Device: High Intensity Focused Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants with Successful Lesion Creation
Feasibility is defined as the ability to create the desired lesion within the anterior nucleus in 80% or more of participants.
Measured: during the surgical procedure
Number of Participants with Adverse Events
Safety will be assessed by the frequency of side effects, e.g. new onset of neurological deficits, performance deterioration on neuropsychological testing.
Measured: 12 months

Secondary outcomes (3)

Change in Number of Seizures Reported Across Time
Captured by participant-recorded seizure questionnaires. Assessed at Baseline, Day 7, Day 30, and months 3, 6, 12 and 24.
Measured: up to 24 months
Total QOLIE-31-P Score Across Time
The Quality of Life in Epilepsy Inventory-31-Problems (QOLIE-31-P) is a survey of health-related quality of life for adults with epilepsy. The QOLIE-31-P is completed by the patient. It contains 39 items, of which a total of 30 are used to make up 7 different subscales. Scores range from 0-100, with higher scores indicating a greater level of functioning and QoL. Assessed at Baseline, and months 1, 3, 6, and 12.
Measured: up to 12 months
Change MRI parameter (water diffusivity)
Water Diffusivity assessed by structural and microstructural MRI in a voxel-wise manner and compared between pre and post operative MRI.
Measured: Baseline, (Day 1), Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Apr 2018May 2028

First posted31 Jan 2018
Study start24 Apr 2018
Primary completionMay 2028 (estimated)
Study completionMay 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Partial Seizures With Secondary GeneralizationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: This is a pilot study. Ten (10) adults with refractory, focal epilepsy with secondary generalization and able to provide informed consent will undergo focused ultrasound (FUS) thalamotomy. Initially, 3 participants will be enrolled and followed for 3 months to assess the safety of study intervention. Pending review by the Data and Safety Monitoring Committee (DSMC) and the US Food and Drug Administration (FDA), additional subjects will be enrolled.
Masking: None (open label)
Enrolment: 10 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03417297
Sponsor's protocol ID: 22-0350
Status last verified: Aug 2026
First submitted: 10 Jan 2018
Last updated: 7 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Krishna V, Mindel J, Sammartino F, Block C, Dwivedi AK, Van Gompel JJ, Fountain N, Fisher R. A phase 1 open-label trial evaluating focused ultrasound unilateral anterior thalamotomy for focal onset epilepsy. Epilepsia. 2023 Apr;64(4):831-842. doi: 10.1111/epi.17535. Epub 2023 Mar 1.
PubMed 36745000