Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-25 @ 3:31 AM
NCT ID:
NCT05032105
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.
* 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 includes the Wechsler Advanced Clinical Solutions - Test of Premorbid Functioning (TOPF).
* ≥ 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.
Exclusion Criteria:
* 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; Parkinson'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 medication).
* 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 scheduled focused ultrasound procedure.
* 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.
* Subjects 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05032105
Study Brief:
Protocol Section:
NCT05032105