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New treatment option for Anxiety
Official title The Impact of Focused Ultrasound Thalamotomy of the Anterior Nucleus for Focal-Onset Epilepsy on Anxiety
ClinicalTrials.gov ID: NCT05032105
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Disabling, medically refractory epilepsy (≥2 anti-epileptic drug failures).
- Focal onset seizures with secondary generalization; with or without primary generalized seizures.
- Previous seizure work-up within 12 months of enrollment date to include: A. Home EEG or EMU video EEG or intracranial EEG. B. High definition MRI...
- ≥ 3 seizures/month on average within 3 months of enrollment.
- Stable medication (including anti-epileptic and psychotropic/psychoactive medications) dosage for 3 months before enrollment.
You likely can't join if
- Low seizure frequency (\<3 seizures/month).
- Generalized epilepsy (Lennox Gastaut, drop attacks).
- Post infectious epilepsy (post herpetic).
- Unable or unwilling to maintain anti-epilepsy drug dosage for 3 months post treatment.
- Active (current in past 12 months), uncontrolled DSM-5 psychiatric disorder, except for anxiety disorders.
- Recent (past 12 months) history of drugs or alcohol abuse as evidenced by diagnosis of Substance Use Disorder.
See the full eligibility criteria
Who can join
- Disabling, medically refractory epilepsy (≥2 anti-epileptic drug failures).
- Focal onset seizures with secondary generalization; with or without primary generalized seizures.
- Previous seizure work-up within 12 months of enrollment date to include: A. Home EEG or EMU video EEG or intracranial EEG. B. High definition MRI imaging/PET imaging. C. Baseline neuropsychological assessment, which...
- ≥ 3 seizures/month on average within 3 months of enrollment.
- Stable medication (including anti-epileptic and psychotropic/psychoactive medications) dosage for 3 months before enrollment.
- Moderate-severe anxiety as measured by the Hamilton Anxiety Rating Scale (HAM-A) score \> 17.
- 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.
- Ability to comply with all testing, follow-ups, and study appointments and protocols.
What rules you out
- Low seizure frequency (\<3 seizures/month).
- Generalized epilepsy (Lennox Gastaut, drop attacks).
- Post infectious epilepsy (post herpetic).
- Unable or unwilling to maintain anti-epilepsy drug dosage for 3 months post treatment.
- Active (current in past 12 months), uncontrolled DSM-5 psychiatric disorder, except for anxiety disorders.
- Recent (past 12 months) history of drugs or alcohol abuse as evidenced by diagnosis of Substance Use Disorder.
- Active suicidal ideation current and past 30 days.
- Clinically significant neurological disorder, except for epilepsy.
- Presence of any neurodegenerative disease suspected on neurological examination. These include but are not limited to: Multisystem atrophy; Progressive supranuclear palsy; Dementia with Lewy bodies; Alzheimer's disease...
- Cerebrovascular disease (multiple CVA or CVA within six months).
- Significant structural brain abnormalities.
- Surgical lesion identifiable on imaging.
- Symptoms and signs of increased intracranial pressure.
- Patients with any types of brain tumors, including metastases.
- Previous vagal nerve stimulator.
- Previous corpus callosotomy.
- Patients who have had deep brain stimulation.
- Prior stereotactic ablation.
- Positive urine drug screen at study entry or any follow-up testing session. For cannabis, exclusion includes positive drug screen with self-report of cannabis use in the past 48 hours.
- Known allergic reaction and/or hypersensitivity to IV dye and/or IV contrasting agent(s).
- Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
- History of claustrophobia.
- Unstable cardiac status including: Unstable angina pectoris on medication; documented myocardial infarction within last 40 days to protocol entry; Congestive heart failure; Severe hypertension (diastolic BP\> 100 on...
- Patients receiving dialysis;
- Patients with risk factors for intraoperative or postoperative bleeding: Platelet count less than 100,000 per cubic millimeter; PT\> 14PTT \> 40; INR \> 1.43.
- History of abnormal bleeding and/or coagulopathy.
- Receiving anticoagulant (e.g., Warfarin) or antiplatelet (e.g., aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk of hemorrhage (e.g., Avastin) within one month of...
- History of intracranial hemorrhage.
- Active or suspected, acute or chronic uncontrolled infection or known life-threatening systemic disease;
- History of immunocompromised status, including patients who are HIV positive.
- people with remarkable atrophy and poor healing capacity of the scalp.
- Evidence for calcifications that might interfere with treatment safety (per CT).
- Skull Density Ratio (SDR) \<0.4.
- Pregnancy or lactation or planning to become pregnant during the time-period of the study.
- Any illness that in the investigators' opinion preclude participation in this study.
- Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hrs of total table time);
- IQ score of \<70 on the Wechsler Advanced Clinical Solutions - Test of Premorbid Functioning (TOPF), measured as part of screening neuropsychological assessment.
- Presence of significant cognitive impairment as determined with a score ≤24 on the Mini Mental Status Examination (MMSE).
- Patients unable to communicate with the investigator and staff.
- Legal incapacity or limited legal capacity.
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.