A Pilot Study: Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 1/12/2019 |
| Start Date: | April 24, 2018 |
| End Date: | February 28, 2021 |
| Contact: | Angela S Emerson, MPH |
| Email: | angela.emerson@osumc.edu |
| Phone: | 614.685.3141 |
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 Magnetic Resonance
Imaging-guided focused ultrasound (MRgFUS) in patients with epilepsy whose medicines are not
working well. The 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 the seizures. Safety will be measured by
recording and analyzing any adverse effects that may occur from the day of the experimental
surgery through 12 months following the surgery.
Imaging-guided focused ultrasound (MRgFUS) in patients with epilepsy whose medicines are not
working well. The 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 the seizures. Safety will be measured by
recording and analyzing any adverse effects that may occur from the day of the experimental
surgery through 12 months following the surgery.
This is a open-label prospective intervention study. Ten (10) adults with refractory,
partial-onset epilepsy with secondary generalization and able to provide informed consent
will be enrolled. 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 Ohio State
University 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), an additional 7
participants will be enrolled.
This pilot study is being conducted to test this 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 absence 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 diary. Quality of life will be measured
by the Quality of Life in Epilepsy Inventory -31. Imaging analysis will include study of
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.
partial-onset epilepsy with secondary generalization and able to provide informed consent
will be enrolled. 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 Ohio State
University 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), an additional 7
participants will be enrolled.
This pilot study is being conducted to test this 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 absence 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 diary. Quality of life will be measured
by the Quality of Life in Epilepsy Inventory -31. Imaging analysis will include study of
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.
Inclusion Criteria:
- Disabling, medically refractory epilepsy (≥2 anti-epileptic drug failures)
- Focal onset seizures with secondary generalization; with or without primary
generalized seizures.
- ≥ 3 seizures/month on average within 3 months of enrollment.
- Stable medication dosage 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).
- Involved care provider.
- Written informed consent to participate.
- 18-65 years of age, inclusive.
- Previous seizure work-up within 12 months of enrollment date to include:
- Home EEG or EMU video EEG or intracranial EEG.
- Baseline neuropsychological assessment, which includes the Wechsler Advanced
Clinical Solutions - Test of Premorbid Functioning (TOPF). Subjects obtaining an
IQ score of ≥70 on the TOPF will be included.
- High definition MRI imaging/PET imaging.
Exclusion Criteria:
- Low seizure frequency (<3 seizures/month).
- Previous vagal nerve stimulator.
- Severe untreated neuropsychiatric disorders (untreated depression or behavioral
problems).
- Recent history of drugs or alcohol abuse.
- Generalized epilepsy (Lennox Gastaut, drop attacks).
- Post infectious epilepsy (post herpetic).
- Previous corpus callosotomy.
- Significant structural brain abnormalities.
- Unable or unwilling to maintain drug dosage for 3 months post treatment.
- Pregnant or not practicing birth control method acceptable to the principal
investigator.
- History of claustrophobia.
- Known allergic reaction and/or hypersensitivity to IV dye and/or IV contrasting
agent(s).
- 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.
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