The Impact of Focused Ultrasound Thalamotomy of the Anterior Nucleus for Focal-Onset Epilepsy on Anxiety
NCT ID: NCT05032105
Last Updated: 2025-03-24
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE1
Total Enrollment
10 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-06-04
Study Completion Date
2025-12-31
Brief Summary
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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.
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A Study to Evaluate the Safety and Effectiveness of Magnetic Resonance-Guided Ultrasound Ablation of the Anterior Nucleus of Thalamus for the Treatment of Drug-resistant Epilepsy.
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Detailed Description
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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.
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.
Conditions
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Anxiety
Medication-refractory Focal-onset Epilepsy
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Single arm, open-label, prospective intervention study of MRgFUSA for adults with refractory, partial-onset epilepsy with moderate-severe anxiety
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
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Intervention
Unilateral Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) of the anterior nucleus of the thalamus (ATN)
Group Type
EXPERIMENTAL
Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA)
Intervention Type
DEVICE
Unilateral Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) of the anterior nucleus of the thalamus (ATN)
Interventions
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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)
Intervention Type
DEVICE
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Ohio State University
OTHER
Sponsor Role
lead
Responsible Party
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Timothy Lucas
Professor, Neurological Surgery
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Kinh Luan Phan, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Timothy Lucas, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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The Ohio State University
Columbus, Ohio, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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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.
Reference Type
BACKGROUND
Krishna 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.
Reference Type
BACKGROUND
Kim 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.
Reference Type
BACKGROUND
Jung 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.
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BACKGROUND
Davidson 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.
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BACKGROUND
Lipsman 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.
Reference Type
BACKGROUND
Hingray 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.
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BACKGROUND
Jackson 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.
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Janiri 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.
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BACKGROUND
Etkin 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.
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Gorka 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.
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BACKGROUND
Phan 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.
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BACKGROUND
Sripada 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.
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BACKGROUND
Paulus 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.
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BACKGROUND
Salanova 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.
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BACKGROUND
Ranjan M, Boutet A, Bhatia S, Wilfong A, Hader W, Lee MR, Rezai AR, Adelson PD. Neuromodulation beyond neurostimulation for epilepsy: scope for focused ultrasound. Expert Rev Neurother. 2019 Oct;19(10):937-943. doi: 10.1080/14737175.2019.1635013. Epub 2019 Jul 2.
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So RQ, Krishna V, King NKK, Yang H, Zhang Z, Sammartino F, Lozano AM, Wennberg RA, Guan C. Prediction and detection of seizures from simultaneous thalamic and scalp electroencephalography recordings. J Neurosurg. 2017 Jun;126(6):2036-2044. doi: 10.3171/2016.7.JNS161282. Epub 2016 Oct 7.
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BACKGROUND
Biraben A, Taussig D, Thomas P, Even C, Vignal JP, Scarabin JM, Chauvel P. Fear as the main feature of epileptic seizures. J Neurol Neurosurg Psychiatry. 2001 Feb;70(2):186-91. doi: 10.1136/jnnp.70.2.186.
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BACKGROUND
Krishna V, Sammartino F, Cosgrove R, Ghanouni P, Schwartz M, Gwinn R, Eisenberg H, Fishman P, Chang JW, Taira T, Kaplitt M, Rezai A, Rumia J, Gedroyc W, Igase K, Kishima H, Yamada K, Ohnishi H, Halpern C. Predictors of Outcomes After Focused Ultrasound Thalamotomy. Neurosurgery. 2020 Aug 1;87(2):229-237. doi: 10.1093/neuros/nyz417.
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Boulogne S, Catenoix H, Ryvlin P, Rheims S. Long-lasting seizure-related anxiety in patients with temporal lobe epilepsy and comorbid psychiatric disorders. Epileptic Disord. 2015 Sep;17(3):340-4. doi: 10.1684/epd.2015.0757.
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Krishna V, King NK, Sammartino F, Strauss I, Andrade DM, Wennberg RA, Lozano AM. Anterior Nucleus Deep Brain Stimulation for Refractory Epilepsy: Insights Into Patterns of Seizure Control and Efficacious Target. Neurosurgery. 2016 Jun;78(6):802-11. doi: 10.1227/NEU.0000000000001197.
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Sammartino F, Yeh FC, Krishna V. Longitudinal analysis of structural changes following unilateral focused ultrasound thalamotomy. Neuroimage Clin. 2019;22:101754. doi: 10.1016/j.nicl.2019.101754. Epub 2019 Mar 12.
Reference Type
BACKGROUND
Other Identifiers
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2023H0325
Identifier Type: -
Identifier Source: org_study_id
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