RECRUITING

The Impact of Focused Ultrasound Thalamotomy of the Anterior Nucleus for Focal-Onset Epilepsy on Anxiety

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Conditions

AnxietyMedication-refractory Focal-onset Epilepsy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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.

Quick Facts

Study Start:2024-01-23
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05032105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Disabling, medically refractory epilepsy (≥2 anti-epileptic drug failures).
  2. * Focal onset seizures with secondary generalization; with or without primary generalized seizures.
  3. * Previous seizure work-up within 12 months of enrollment date to include:
  4. * ≥ 3 seizures/month on average within 3 months of enrollment.
  5. * Stable medication (including anti-epileptic and psychotropic/psychoactive medications) dosage for 3 months before enrollment.
  6. * Moderate-severe anxiety as measured by the Hamilton Anxiety Rating Scale (HAM-A) score \> 17.
  7. * Anterior Nucleus (AN) identifiable on MRI (structural T1 and T2 images).
  8. * Willing to maintain seizure diary (3 months before \& 3 months after).
  9. * Involved care provider.
  10. * Written informed consent to participate.
  11. * Ability to comply with all testing, follow-ups, and study appointments and protocols.
  1. * Low seizure frequency (\<3 seizures/month).
  2. * Generalized epilepsy (Lennox Gastaut, drop attacks).
  3. * Post infectious epilepsy (post herpetic).
  4. * Unable or unwilling to maintain anti-epilepsy drug dosage for 3 months post treatment.
  5. * Active (current in past 12 months), uncontrolled DSM-5 psychiatric disorder, except for anxiety disorders.
  6. * Recent (past 12 months) history of drugs or alcohol abuse as evidenced by diagnosis of Substance Use Disorder.
  7. * Active suicidal ideation current and past 30 days.
  8. * Clinically significant neurological disorder, except for epilepsy.
  9. * 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.
  10. * Cerebrovascular disease (multiple CVA or CVA within six months).
  11. * Significant structural brain abnormalities.
  12. * Surgical lesion identifiable on imaging.
  13. * Symptoms and signs of increased intracranial pressure.
  14. * Patients with any types of brain tumors, including metastases.
  15. * Previous vagal nerve stimulator.
  16. * Previous corpus callosotomy.
  17. * Patients who have had deep brain stimulation.
  18. * Prior stereotactic ablation.
  19. * 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.
  20. * Known allergic reaction and/or hypersensitivity to IV dye and/or IV contrasting agent(s).
  21. * Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
  22. * History of claustrophobia.
  23. * 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).
  24. * Patients receiving dialysis;
  25. * Patients with risk factors for intraoperative or postoperative bleeding: Platelet count less than 100,000 per cubic millimeter; PT\> 14PTT \> 40; INR \> 1.43.
  26. * History of abnormal bleeding and/or coagulopathy.
  27. * 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.
  28. * History of intracranial hemorrhage.
  29. * Active or suspected, acute or chronic uncontrolled infection or known life-threatening systemic disease;
  30. * History of immunocompromised status, including patients who are HIV positive.
  31. * Subjects with remarkable atrophy and poor healing capacity of the scalp.
  32. * Evidence for calcifications that might interfere with treatment safety (per CT).
  33. * Skull Density Ratio (SDR) \<0.4.
  34. * Pregnancy or lactation or planning to become pregnant during the time-period of the study.
  35. * Any illness that in the investigators' opinion preclude participation in this study.
  36. * 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);
  37. * IQ score of \<70 on the Wechsler Advanced Clinical Solutions - Test of Premorbid Functioning (TOPF), measured as part of screening neuropsychological assessment.
  38. * Presence of significant cognitive impairment as determined with a score ≤24 on the Mini Mental Status Examination (MMSE).
  39. * Patients unable to communicate with the investigator and staff.
  40. * Legal incapacity or limited legal capacity.

Contacts and Locations

Study Contact

Anne-Marie Duchemin
CONTACT
614-293-5517
anne-marie.duchemin@osumc.edu

Principal Investigator

Kinh Luan Phan, MD
PRINCIPAL_INVESTIGATOR
Ohio State University
Timothy Lucas, MD
PRINCIPAL_INVESTIGATOR
Ohio State University

Study Locations (Sites)

The Ohio State University
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State University

  • Kinh Luan Phan, MD, PRINCIPAL_INVESTIGATOR, Ohio State University
  • Timothy Lucas, MD, PRINCIPAL_INVESTIGATOR, Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-23
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-01-23
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Anxiety
  • Medication-refractory Focal-onset Epilepsy