Can sound waves calm both seizures and anxiety?
NCT ID NCT05032105
First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time
Summary
This early-stage trial is testing whether a non-invasive procedure called focused ultrasound can safely reduce both seizures and anxiety in people with treatment-resistant epilepsy. The ultrasound targets a small region in the brain thought to be involved in both conditions. Researchers are evaluating safety, changes in anxiety symptoms, and brain responses to threat.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) — a non-invasive procedure that uses ultrasound waves to target a small area in the brain
- What this could lead to
- If it works, this could offer a non-invasive surgical option for people with epilepsy and anxiety who have not responded to medication.
- What could go wrong
- This is a very early, small trial with only 2 participants, so results may not apply broadly. The procedure involves creating a brain lesion, which carries risks like swelling, bleeding, or neurological changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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2 people
The number who actually took part.
- Started
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Jun 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Ohio State University
Columbus, Ohio, 43210, United States
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