NCT05032105 The Impact of Focused Ultrasound Thalamotomy of the Anterior Nucleus for Focal-Onset Epilepsy on Anxiety
| NCT ID | NCT05032105 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Ohio State University |
| Condition | Anxiety |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-06-04 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2024-06-04 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Kinh Luan Phan, MD
PRINCIPAL INVESTIGATOR
Ohio State University
Frequently Asked Questions
Who can join the NCT05032105 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Anxiety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05032105 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05032105 currently recruiting?
Yes, NCT05032105 is actively recruiting participants. Contact the research team at anne-marie.duchemin@osumc.edu for enrollment information.
Where is the NCT05032105 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT05032105 clinical trial?
NCT05032105 is sponsored by Ohio State University. The principal investigator is Kinh Luan Phan, MD at Ohio State University. The trial plans to enroll 10 participants.
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