Focused Ultrasound Thalamotomy for Epilepsy and Anxiety

Overseen By Anne-Marie Duchemin

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ohio State University

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Low seizure frequency, Generalized epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new, non-invasive brain procedure using focused ultrasound to help individuals with hard-to-treat epilepsy and anxiety. The goal is to determine if Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) is safe and effective in reducing anxiety and seizures by targeting the anterior nucleus of the thalamus. This trial suits those who experience frequent seizures despite multiple medications and who manage anxiety. Participants should be comfortable following study protocols and willing to maintain a seizure diary. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Do I have to stop taking my current medications for the trial?

The trial requires that you maintain a stable dosage of your current anti-epileptic and psychotropic/psychoactive medications for 3 months before and after enrollment. So, you should not stop taking your current medications.

What prior data suggests that this procedure is safe for patients with epilepsy and anxiety?

Research shows that Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) is being explored as a potential treatment for epilepsy and anxiety. This non-invasive procedure uses sound waves to target specific small areas in the brain, such as the anterior nucleus of the thalamus, which may be linked to seizures and anxiety.

Studies have found that MRgFUSA is generally well-tolerated. While some research supports its use for treating epilepsy, information on its long-term safety remains limited. Therefore, its long-term safety is not yet certain.

Since this trial is in an early stage, it primarily aims to understand the safety and basic effects of MRgFUSA. Although initial results are promising, more research is needed to fully understand its safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) for epilepsy and anxiety because it offers a non-invasive alternative to traditional surgical treatments. Unlike standard options that might involve medication or open surgery, MRgFUSA uses precise ultrasound waves to target and ablate specific areas of the brain, potentially reducing side effects and recovery time. This technique allows for highly accurate treatment of the anterior nucleus of the thalamus, which plays a key role in these conditions, without the need for incisions. The precision and non-invasive nature of MRgFUSA make it a promising option for patients who are looking for effective treatment with minimal disruption to their daily lives.

What evidence suggests that Magnetic Resonance Imaging-guided Focused Ultrasound Ablation might be an effective treatment for epilepsy and anxiety?

Research has shown that MRI-guided Focused Ultrasound Ablation (MRgFUSA), which participants in this trial will receive, may help treat epilepsy unresponsive to medication. This method accurately targets the anterior nucleus of the thalamus, a brain region believed to contribute to seizures. High-intensity focused ultrasounds (HIFU) are increasingly used to manage this type of epilepsy, with MRI aiding in precise targeting. Although evidence remains in the early stages, initial findings suggest that MRgFUSA could improve outcomes for patients with drug-resistant epilepsy. This approach might also help reduce anxiety related to epilepsy. ^{1 2 5 6 7}

Who Is on the Research Team?

Kinh Luan Phan, MD

Principal Investigator

Ohio State University

Timothy Lucas, MD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for adults with focal epilepsy and moderate to severe anxiety who haven't responded well to treatments. They must have had a stable medication dose for 3 months, experience at least 3 seizures per month, and be able to follow the study's procedures. People can't join if they have low seizure frequency, certain other neurological conditions, recent substance abuse, or are pregnant.

Inclusion Criteria

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)

Ability to comply with all testing, follow-ups, and study appointments and protocols

I have had 3 or more seizures a month in the last 3 months.

Exclusion Criteria

Active suicidal ideation current and past 30 days

I am currently on dialysis.

IQ score of <70 on the Wechsler Advanced Clinical Solutions - Test of Premorbid Functioning (TOPF), measured as part of screening neuropsychological assessment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo Unilateral Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) of the anterior nucleus of the thalamus

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including neuroimaging and neuropsychological assessments

12 months

Multiple visits at day 1, week 1, month 1, month 3, month 6, and month 12

Long-term Follow-up

Participants' anxiety and seizure frequency are monitored using various assessments

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA)

Trial Overview The trial tests MR-guided Focused Ultrasound Ablation (MRgFUSA) on the anterior nucleus of the thalamus in patients with treatment-resistant focal epilepsy and anxiety. It aims to see if this non-invasive procedure is safe and reduces both seizures and anxiety symptoms.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Unilateral Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) of the anterior nucleus of the thalamus (ATN)

Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) is already approved in United States for the following indications:

Approved in United States as MRgFUSA for:

• Essential Tremor
• Tremor-dominant Parkinson's disease
• Internal Globus Pallidus for Parkinson's disease dyskinesia

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05032105

Study Details | NCT05032105 | The Impact of Focused ... The purpose of this study is to evaluate the feasibility, safety, and effects on anxiety of high intensity focused ultrasound ablation (FUSA) in patients ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10672423/

MR-Guided Focused Ultrasound for Refractory Epilepsy ... magnetic resonance imaging can improve outcomes ... Image-guided high-intensity focused ultrasound for conduction block of peripheral nerves.

3. karger.com karger.com/doi/10.1159/000545716

Focused Ultrasound in the Treatment of Epilepsy When paired with magnetic resonance imaging (MRI) for targeting, both ablative and neuromodulatory FUS offer exceptional spatial precision and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0035378723011451

Focused ultrasounds: What is their future in epileptology? ... High intensity focused ultrasounds (HIFU) are being increasingly advocated as a useful tool in the management of focal drug-resistant epilepsy.

5. provider.healthybluenc.com provider.healthybluenc.com/medpolicies/healthybluenc/active/mp_pw_a050053.html

MED.00057 MRI Guided High Intensity Focused ... The evidence regarding bilateral MRgFUS is in the early stages and is limited to short-term outcomes with no data on long-term safety. ... Secondary efficacy ...

6. anthem.com anthem.com/medpolicies/abc/active/mp_pw_a050053.html

MED.00057 MRI Guided High Intensity Focused ... This document addresses magnetic resonance imaging (MRI) guided high intensity focused ultrasound ... outcomes with no data on long-term safety. The current ...

7. fusfoundation.org fusfoundation.org/for-researchers-and-clinicians/foundation-funded-research-projects/

Foundation Funded Research Projects Will ablation of the pallidothalamic tract treat cervical dystonia? A pilot trial of safety and effectiveness of Magnetic Resonance-guided Focused Ultrasound ( ...