AnxietyPhase 1NCT05032105
The Impact of Focused Ultrasound Thalamotomy of the Anterior Nucleus for Focal-Onset Epilepsy on Anxiety
A Phase 1 study testing Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) in people with Anxiety and Medication-refractory Focal-onset Epilepsy, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety, Medication-refractory Focal-onset Epilepsy
- What is being tested?
- Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2024to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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:
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Show all 40Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: .An Open-label Clinical Trial Evaluating the ExAblate Model 4000 Type-1 Focused Ultrasound Unilateral Thalamotomy for Patients With Treatment-refractory Focal Onset Epilepsy and Comorbid Anxiety.
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.
Read the detailed description
This is an open-label, Phase 1 prospective intervention study. Ten (10) adults with refractory, partial-onset epilepsy with moderate-severe anxiety and able to provide informed consent will be enrolled.
Patients, eligible for Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) of the anterior nucleus of the thalamus (ATN) for treatment-refractory epilepsy and who present moderate-severe anxiety will be enrolled. In addition to the diagnosis of medically refractory epilepsy, patients will need to present moderate to severe anxiety (as measured by the Hamilton Anxiety Rating Scale, HAM-A; HAMA score > 17) and other protocol specific inclusion and exclusion criteria.
Medication-refractory partial or focal-onset epilepsy is often associated with enhanced fear behaviors and clinical anxiety. Exaggerated amygdala reactivity to threat is a cardinal neural phenotype of fear and anxiety disorders. The study will determine if MRgFUSA-ATN is feasible and safe and its effects on anxiety, using neuroimaging and neurological, neurocognitive/neuropsychological, psychiatric assessments before, and 1 day, 1 week, 1 month, 3 months, 6 months and 12 months post MRgFUSA.
Feasibility is defined as the ability to create the desired lesion within the anterior nucleus of the thalamus and perform fMRI to measure threat reactivity.
Safety will be measured by recording and analyzing any adverse effects that may occur from before surgery through 12 months following the surgery. These will include any new onset of neurological deficits, or performance deterioration on neuropsychological testing.
Effects on anxiety will be measured using amygdala reactivity to threat by fMRI and patient- and clinician-reported measures of anxiety symptoms before and after MRgFUSA-ATN up to 12 months.
- Being tested
- Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA)
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA)Device
Unilateral Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) of the anterior nucleus of the thalamus (ATN)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Unilateral Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) of the anterior nucleus of the thalamus (ATN) Receives: Device: Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Safety will be determined by an evaluation of the incidence and severity of MRgFUSA-ATN and other research procedures related adverse events from the 1st study visit through the 12-month post-treatment time point. Post-procedural imaging will be evaluated for evidence of swelling, hemorrhage, and the evolution of the ATN lesion. Emergence of complications will be monitored by neurological examination at day 1, day 7, month 1, month 3, month 6 and month 12 post-procedure. A comprehensive battery of neuropsychological assessments will be conducted by board-certified neuropsychologists at study screening, 3-month and 12-month postoperative time points. All events that are not procedure related will also be captured and recorded.
Measured: 12 months
Target
Feasibility will be determined by ability to create the desired lesion within the anterior nucleus of the thalamus as assessed by neuroimaging
Measured: 1 month
Change in Anxiety symptoms
Change in anxiety symptoms will be measured using clinician-administered HAM-A scale before the procedure and at various time points after the procedure.
HAM-A is the scale of reference used in clinical trials to rate the severity of symptoms of anxiety in patients. It will be collected before and after the procedure at day 1, 7, months 1, 3, 6 and 12 to determine any effect and its change overtime.
Measured: 12 months
Effect on Threat Reactivity
Change in Threat reactivity measured by fMRI task just before and after MRgFUSA
Measured: 1 day
Secondary outcomes (6)
Change in seizure frequency
Change in seizure frequency between before the procedure and after will be assessed by online or hard copy seizure diary
Measured: 12 months
Ability to perform the threat reactivity fMRI task just before and after MRgFUSA
Ability to perform the fMRI task before and after MRgFUSA will be assessed by recording any delay or inability to perform the assessment
Measured: 4 years
Change in self-reported anxiety symptoms
Change in Self-report symptoms of anxiety using the Beck Anxiety Inventory from before the procedure up to 12 months post-procedure.
Measured: 12 months
Change in self-reported anxiety symptoms
Change in Self-report symptoms on the Anxiety, Depression, Stress scale from before the procedure up to 12 months post-procedure
Measured: 12 months
Change in quality of life
Change in quality of life between before and after the procedure will be measured using the Quality of Life in Epilepsy Inventory before and up to 12 months after the procedure
Measured: 12 months
Rate of Patient Accrual
Feasibility will be assessed by measuring the rate of patient accrual over the 4 years of the study
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start4 Jun 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, open-label, prospective intervention study of MRgFUSA for adults with refractory, partial-onset epilepsy with moderate-severe anxiety
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kinh Luan Phan, Ohio State University
- Investigators
- Kinh Luan Phan, MD, Principal investigator, Ohio State UniversityTimothy Lucas, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032105
- Sponsor's protocol ID
- 2023H0325
- Status last verified
- Jul 2026
- First submitted
- 21 Aug 2021
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data will be shared via the NIMH Data Archive, in compliance with NIH policy
Publications
Rabut C, Yoo S, Hurt RC, Jin Z, Li H, Guo H, Ling B, Shapiro MG. Ultrasound Technologies for Imaging and Modulating Neural Activity. Neuron. 2020 Oct 14;108(1):93-110. doi: 10.1016/j.neuron.2020.09.003.
PubMed 33058769Krishna V, Sammartino F, Rezai A. A Review of the Current Therapies, Challenges, and Future Directions of Transcranial Focused Ultrasound Technology: Advances in Diagnosis and Treatment. JAMA Neurol. 2018 Feb 1;75(2):246-254. doi: 10.1001/jamaneurol.2017.3129.
PubMed 29228074Kim M, Kim CH, Jung HH, Kim SJ, Chang JW. Treatment of Major Depressive Disorder via Magnetic Resonance-Guided Focused Ultrasound Surgery. Biol Psychiatry. 2018 Jan 1;83(1):e17-e18. doi: 10.1016/j.biopsych.2017.05.008. Epub 2017 May 12. No abstract available.
PubMed 28601192Jung HH, Kim SJ, Roh D, Chang JG, Chang WS, Kweon EJ, Kim CH, Chang JW. Bilateral thermal capsulotomy with MR-guided focused ultrasound for patients with treatment-refractory obsessive-compulsive disorder: a proof-of-concept study. Mol Psychiatry. 2015 Oct;20(10):1205-11. doi: 10.1038/mp.2014.154. Epub 2014 Nov 25.
PubMed 25421403Davidson B, Hamani C, Rabin JS, Goubran M, Meng Y, Huang Y, Baskaran A, Sharma S, Ozzoude M, Richter MA, Levitt A, Giacobbe P, Hynynen K, Lipsman N. Magnetic resonance-guided focused ultrasound capsulotomy for refractory obsessive compulsive disorder and major depressive disorder: clinical and imaging results from two phase I trials. Mol Psychiatry. 2020 Sep;25(9):1946-1957. doi: 10.1038/s41380-020-0737-1. Epub 2020 May 14.
PubMed 32404942Lipsman N, Schwartz ML, Huang Y, Lee L, Sankar T, Chapman M, Hynynen K, Lozano AM. MR-guided focused ultrasound thalamotomy for essential tremor: a proof-of-concept study. Lancet Neurol. 2013 May;12(5):462-8. doi: 10.1016/S1474-4422(13)70048-6. Epub 2013 Mar 21.
PubMed 23523144Hingray C, McGonigal A, Kotwas I, Micoulaud-Franchi JA. The Relationship Between Epilepsy and Anxiety Disorders. Curr Psychiatry Rep. 2019 Apr 29;21(6):40. doi: 10.1007/s11920-019-1029-9.
PubMed 31037466Jackson MJ, Turkington D. Depression and anxiety in epilepsy. J Neurol Neurosurg Psychiatry. 2005 Mar;76 Suppl 1(Suppl 1):i45-47. doi: 10.1136/jnnp.2004.060467. No abstract available.
PubMed 15718221Janiri D, Moser DA, Doucet GE, Luber MJ, Rasgon A, Lee WH, Murrough JW, Sani G, Eickhoff SB, Frangou S. Shared Neural Phenotypes for Mood and Anxiety Disorders: A Meta-analysis of 226 Task-Related Functional Imaging Studies. JAMA Psychiatry. 2020 Feb 1;77(2):172-179. doi: 10.1001/jamapsychiatry.2019.3351.
PubMed 31664439Etkin A, Wager TD. Functional neuroimaging of anxiety: a meta-analysis of emotional processing in PTSD, social anxiety disorder, and specific phobia. Am J Psychiatry. 2007 Oct;164(10):1476-88. doi: 10.1176/appi.ajp.2007.07030504.
PubMed 17898336Gorka SM, Young CB, Klumpp H, Kennedy AE, Francis J, Ajilore O, Langenecker SA, Shankman SA, Craske MG, Stein MB, Phan KL. Emotion-based brain mechanisms and predictors for SSRI and CBT treatment of anxiety and depression: a randomized trial. Neuropsychopharmacology. 2019 Aug;44(9):1639-1648. doi: 10.1038/s41386-019-0407-7. Epub 2019 May 6.
PubMed 31060042Phan KL, Coccaro EF, Angstadt M, Kreger KJ, Mayberg HS, Liberzon I, Stein MB. Corticolimbic brain reactivity to social signals of threat before and after sertraline treatment in generalized social phobia. Biol Psychiatry. 2013 Feb 15;73(4):329-36. doi: 10.1016/j.biopsych.2012.10.003. Epub 2012 Nov 17.
PubMed 23164370Sripada CS, Angstadt M, McNamara P, King AC, Phan KL. Effects of alcohol on brain responses to social signals of threat in humans. Neuroimage. 2011 Mar 1;55(1):371-80. doi: 10.1016/j.neuroimage.2010.11.062. Epub 2010 Nov 29.
PubMed 21122818Paulus MP, Feinstein JS, Castillo G, Simmons AN, Stein MB. Dose-dependent decrease of activation in bilateral amygdala and insula by lorazepam during emotion processing. Arch Gen Psychiatry. 2005 Mar;62(3):282-8. doi: 10.1001/archpsyc.62.3.282.
PubMed 15753241Salanova V, Witt T, Worth R, Henry TR, Gross RE, Nazzaro JM, Labar D, Sperling MR, Sharan A, Sandok E, Handforth A, Stern JM, Chung S, Henderson JM, French J, Baltuch G, Rosenfeld WE, Garcia P, Barbaro NM, Fountain NB, Elias WJ, Goodman RR, Pollard JR, Troster AI, Irwin CP, Lambrecht K, Graves N, Fisher R; SANTE Study Group. Long-term efficacy and safety of thalamic stimulation for drug-resistant partial epilepsy. Neurology. 2015 Mar 10;84(10):1017-25. doi: 10.1212/WNL.0000000000001334. Epub 2015 Feb 6.
PubMed 25663221
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- .An Open-label Clinical Trial Evaluating the ExAblate Model 4000 Type-1 Focused Ultrasound Unilateral Thalamotomy for Patients With Treatment-refractory Focal Onset Epilepsy and Comorbid Anxiety.
- ClinicalTrials.gov ID
- NCT05032105
- Acronym / sponsor ID
- 2023H0325
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label, Phase 1 prospective intervention study. Ten (10) adults with refractory, partial-onset epilepsy with moderate-severe anxiety and able to provide informed consent will be enrolled.
Patients, eligible for Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) of the anterior nucleus of the thalamus (ATN) for treatment-refractory epilepsy and who present moderate-severe anxiety will be enrolled. In addition to the diagnosis of medically refractory epilepsy, patients will need to present moderate to severe anxiety (as measured by the Hamilton Anxiety Rating Scale, HAM-A; HAMA score > 17) and other protocol specific inclusion and exclusion criteria.
Medication-refractory partial or focal-onset epilepsy is often associated with enhanced fear behaviors and clinical anxiety. Exaggerated amygdala reactivity to threat is a cardinal neural phenotype of fear and anxiety disorders. The study will determine if MRgFUSA-ATN is feasible and safe and its effects on anxiety, using neuroimaging and neurological, neurocognitive/neuropsychological, psychiatric assessments before, and 1 day, 1 week, 1 month, 3 months, 6 months and 12 months post MRgFUSA.
Feasibility is defined as the ability to create the desired lesion within the anterior nucleus of the thalamus and perform fMRI to measure threat reactivity.
Safety will be measured by recording and analyzing any adverse effects that may occur from before surgery through 12 months following the surgery. These will include any new onset of neurological deficits, or performance deterioration on neuropsychological testing.
Effects on anxiety will be measured using amygdala reactivity to threat by fMRI and patient- and clinician-reported measures of anxiety symptoms before and after MRgFUSA-ATN up to 12 months.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, open-label, prospective intervention study of MRgFUSA for adults with refractory, partial-onset epilepsy with moderate-severe anxiety
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA)Unilateral Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) of the anterior nucleus of the thalamus (ATN) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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.
Key exclusion criteria (40 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA)Unilateral Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) of the anterior nucleus of the thalamus (ATN) | Device | Intervention |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 12 months
Safety will be determined by an evaluation of the incidence and severity of MRgFUSA-ATN and other research procedures related adverse events from the 1st study visit through the 12-month post-treatment time point. Post-procedural imaging will be evaluated for evidence of swelling, hemorrhage, and the evolution of the ATN lesion. Emergence of complications will be monitored by neurological examination at day 1, day 7, month 1, month 3, month 6 and month 12 post-procedure. A comprehensive battery of neuropsychological assessments will be conducted by board-certified neuropsychologists at study screening, 3-month and 12-month postoperative time points. All events that are not procedure related will also be captured and recorded.
Target
Time frame: 1 month
Feasibility will be determined by ability to create the desired lesion within the anterior nucleus of the thalamus as assessed by neuroimaging
Change in Anxiety symptoms
Time frame: 12 months
Change in anxiety symptoms will be measured using clinician-administered HAM-A scale before the procedure and at various time points after the procedure. HAM-A is the scale of reference used in clinical trials to rate the severity of symptoms of anxiety in patients. It will be collected before and after the procedure at day 1, 7, months 1, 3, 6 and 12 to determine any effect and its change overtime.
Effect on Threat Reactivity
Time frame: 1 day
Change in Threat reactivity measured by fMRI task just before and after MRgFUSA
6 secondary outcomes
Change in seizure frequency
Time frame: 12 months
Ability to perform the threat reactivity fMRI task just before and after MRgFUSA
Time frame: 4 years
Change in self-reported anxiety symptoms
Time frame: 12 months
Change in self-reported anxiety symptoms
Time frame: 12 months
Change in quality of life
Time frame: 12 months
Rate of Patient Accrual
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Background: PubMed 33058769Rabut C, Yoo S, Hurt RC, Jin Z, Li H, Guo H, Ling B, Shapiro MG. Ultrasound Technologies for Imaging and Modulating Neural Activity. Neuron. 2020 Oct 14;108(1):93-110. doi: 10.1016/j.neuron.2020.09.003.
- Background: PubMed 29228074Krishna V, Sammartino F, Rezai A. A Review of the Current Therapies, Challenges, and Future Directions of Transcranial Focused Ultrasound Technology: Advances in Diagnosis and Treatment. JAMA Neurol. 2018 Feb 1;75(2):246-254. doi: 10.1001/jamaneurol.2017.3129.
- Background: PubMed 28601192Kim M, Kim CH, Jung HH, Kim SJ, Chang JW. Treatment of Major Depressive Disorder via Magnetic Resonance-Guided Focused Ultrasound Surgery. Biol Psychiatry. 2018 Jan 1;83(1):e17-e18. doi: 10.1016/j.biopsych.2017.05.008. Epub 2017 May 12. No abstract available.
- Background: PubMed 25421403Jung HH, Kim SJ, Roh D, Chang JG, Chang WS, Kweon EJ, Kim CH, Chang JW. Bilateral thermal capsulotomy with MR-guided focused ultrasound for patients with treatment-refractory obsessive-compulsive disorder: a proof-of-concept study. Mol Psychiatry. 2015 Oct;20(10):1205-11. doi: 10.1038/mp.2014.154. Epub 2014 Nov 25.
- Background: PubMed 32404942Davidson B, Hamani C, Rabin JS, Goubran M, Meng Y, Huang Y, Baskaran A, Sharma S, Ozzoude M, Richter MA, Levitt A, Giacobbe P, Hynynen K, Lipsman N. Magnetic resonance-guided focused ultrasound capsulotomy for refractory obsessive compulsive disorder and major depressive disorder: clinical and imaging results from two phase I trials. Mol Psychiatry. 2020 Sep;25(9):1946-1957. doi: 10.1038/s41380-020-0737-1. Epub 2020 May 14.
- Background: PubMed 23523144Lipsman N, Schwartz ML, Huang Y, Lee L, Sankar T, Chapman M, Hynynen K, Lozano AM. MR-guided focused ultrasound thalamotomy for essential tremor: a proof-of-concept study. Lancet Neurol. 2013 May;12(5):462-8. doi: 10.1016/S1474-4422(13)70048-6. Epub 2013 Mar 21.
- Background: PubMed 31037466Hingray C, McGonigal A, Kotwas I, Micoulaud-Franchi JA. The Relationship Between Epilepsy and Anxiety Disorders. Curr Psychiatry Rep. 2019 Apr 29;21(6):40. doi: 10.1007/s11920-019-1029-9.
- Background: PubMed 15718221Jackson MJ, Turkington D. Depression and anxiety in epilepsy. J Neurol Neurosurg Psychiatry. 2005 Mar;76 Suppl 1(Suppl 1):i45-47. doi: 10.1136/jnnp.2004.060467. No abstract available.
- Background: PubMed 31664439Janiri D, Moser DA, Doucet GE, Luber MJ, Rasgon A, Lee WH, Murrough JW, Sani G, Eickhoff SB, Frangou S. Shared Neural Phenotypes for Mood and Anxiety Disorders: A Meta-analysis of 226 Task-Related Functional Imaging Studies. JAMA Psychiatry. 2020 Feb 1;77(2):172-179. doi: 10.1001/jamapsychiatry.2019.3351.
- Background: PubMed 17898336Etkin A, Wager TD. Functional neuroimaging of anxiety: a meta-analysis of emotional processing in PTSD, social anxiety disorder, and specific phobia. Am J Psychiatry. 2007 Oct;164(10):1476-88. doi: 10.1176/appi.ajp.2007.07030504.
- Background: PubMed 31060042Gorka SM, Young CB, Klumpp H, Kennedy AE, Francis J, Ajilore O, Langenecker SA, Shankman SA, Craske MG, Stein MB, Phan KL. Emotion-based brain mechanisms and predictors for SSRI and CBT treatment of anxiety and depression: a randomized trial. Neuropsychopharmacology. 2019 Aug;44(9):1639-1648. doi: 10.1038/s41386-019-0407-7. Epub 2019 May 6.
- Background: PubMed 23164370Phan KL, Coccaro EF, Angstadt M, Kreger KJ, Mayberg HS, Liberzon I, Stein MB. Corticolimbic brain reactivity to social signals of threat before and after sertraline treatment in generalized social phobia. Biol Psychiatry. 2013 Feb 15;73(4):329-36. doi: 10.1016/j.biopsych.2012.10.003. Epub 2012 Nov 17.
- Individual participant dataSharing planned: No. Data will be shared via the NIMH Data Archive, in compliance with NIH policy
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Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kinh Luan Phan, MD principal investigator
Ohio State University
Timothy Lucas, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) in people with Anxiety and Medication-refractory Focal-onset Epilepsy, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05032105, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.