Using focused ultrasound to treat epilepsy

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

This study is testing whether a new ultrasound treatment can help adults with hard-to-control epilepsy by targeting a specific part of their brain to reduce seizures.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of North Carolina, Chapel Hill (Academic / other)
• Locations: 1 site (Chapel Hill, North Carolina)
• Trial ID: NCT03417297 on ClinicalTrials.gov

What this trial studies

This pilot study evaluates the safety and feasibility of Magnetic Resonance Imaging-guided focused ultrasound (MRgFUS) for patients with refractory partial-onset epilepsy. The study involves ten adults who will undergo a procedure using the ExAblate transcranial system to target the Anterior Nucleus of the brain, which may be responsible for their seizures. Participants will be monitored for adverse effects and seizure frequency, with assessments conducted over a 12-month period. The study aims to confirm the device's ability to accurately ablate the target area and improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults with disabling, medically refractory epilepsy characterized by focal onset seizures and secondary generalization.

Not a fit: Patients who have not experienced multiple medication failures or those with non-focal seizures may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for patients with epilepsy who do not respond to medication.

How similar studies have performed: While focused ultrasound is a novel approach in epilepsy treatment, similar studies have shown promising results in other neurological conditions.

Eligibility criteria

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.
* Previous seizure work-up within 12 months of enrollment date to include:

  1. Home EEG or Epilepsy Monitoring Unit (EMU) video EEG or intracranial EEG.
  2. 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.
  3. High-definition MRI imaging/Position emission tomography (PET) imaging

Exclusion Criteria:

* Low seizure frequency (\<3 seizures/month).
* Indwelling vagal nerve stimulator.
* Severe untreated neuropsychiatric disorders (untreated depression or behavioral problems).
* Recent history of drugs or alcohol abuse.
* Primary generalized epilepsy (Lennox Gastaut, drop attacks).
* Post infectious epilepsy (i.e., 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).
* MRI contraindicated implanted metal or medical device.
* Uncontrolled hypertension or other comorbid conditions
* 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.

Where this trial is running

Chapel Hill, North Carolina

• University of North Carolina-Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Vibhor Krishna, MD SM — University of North Carolina, Chapel Hill
• Study coordinator: Heather L Ward, BS

Conditions Partial Seizures With Secondary Generalization