Actively Recruiting
The Impact of Focused Ultrasound Thalamotomy of the Anterior Nucleus for Focal-Onset Epilepsy on Anxiety
Led by Ohio State University · Updated on 2025-03-24
10
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Impact of Focused Ultrasound Thalamotomy of the Anterior Nucleus for Focal-Onset Epilepsy on Anxiety
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Disabling, medically refractory epilepsy with failure of two or more anti-epileptic drugs
- Focal onset seizures with or without secondary generalization
- Recent seizure evaluation within 12 months including EEG and MRI/PET imaging
- Average of three or more seizures per month in the last three months
- Stable medication doses for at least three months before enrollment
- Moderate to severe anxiety with Hamilton Anxiety Rating Scale score greater than 17
- Anterior nucleus of the thalamus identifiable on MRI
- Willingness to maintain a seizure diary for three months before and after treatment
- Presence of an involved care provider
- Ability to provide written informed consent
- Ability to comply with all study testing, follow-ups, and appointments
You will not qualify if you...
- Low seizure frequency (less than three seizures per month)
- Generalized epilepsy such as Lennox Gastaut syndrome or drop attacks
- Post infectious epilepsy such as post herpetic epilepsy
- Inability or unwillingness to maintain anti-epileptic drug dosage for three months after treatment
- Active or uncontrolled psychiatric disorders other than anxiety
- Recent history of substance abuse in the past 12 months
- Active suicidal thoughts in the past 30 days
- Clinically significant neurological disorders besides epilepsy
- Neurodegenerative diseases such as Parkinson's or Alzheimer's
- Recent cerebrovascular disease or significant structural brain abnormalities
- Presence of brain tumors
- Previous brain surgeries including vagal nerve stimulation or deep brain stimulation
- Positive urine drug screen at study entry or follow-ups
- Allergic reactions to IV dye or contrast agents
- MRI contraindications such as implanted metallic devices or claustrophobia
- Unstable heart conditions or severe hypertension
- Receiving dialysis
- Risk factors for bleeding or abnormal blood clotting
- History of intracranial hemorrhage
- Active or uncontrolled infections or life-threatening diseases
- Immunocompromised status including HIV positive
- Poor scalp healing or skull abnormalities affecting treatment
- Skull Density Ratio less than 0.4
- Pregnancy, breastfeeding, or planning pregnancy during the study
- IQ score below 70 or significant cognitive impairment
- Inability to communicate with study staff
- Legal incapacity or limited legal capacity
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
A
Anne-Marie Duchemin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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