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Procedure
Patients receiving Craniotomy for Focused Ultrasound
N/A
Waitlist Available
Led By Wynn Legon, PhD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Receiving a Craniotomy with brain mapping
Receiving treatment or monitoring for Epilepsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, immediately after ultrasound (same day, approximately 5-10 minutes after baseline)
Awards & highlights
Study Summary
This trial is testing the effect of low-intensity focused ultrasound on the nervous system, in specific populations within the UVA health system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, immediately after ultrasound (same day, approximately 5-10 minutes after baseline)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, immediately after ultrasound (same day, approximately 5-10 minutes after baseline)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Electrophysiological Changes as a result of Ultrasound
Trial Design
5Treatment groups
Experimental Treatment
Group I: Tremor Patients receiving FUSExperimental Treatment1 Intervention
Patients undergoing high intensity FUS treatment for tremor will be asked to wear a research provided EEG cap while undergoing a non-invasive low intensity Focused Ultrasound research procedure and changes in their tremor will be monitored.
Group II: Tremor Patients receiving DBSExperimental Treatment1 Intervention
Patients undergoing Deep Brain Stimulation (DBS) treatment for tremor will receive a non-invasive Focused Ultrasound stimulation observed through their newly implanted electrode.
Group III: Patients receiving Spinal SurgeryExperimental Treatment1 Intervention
Patients receiving a spinal surgery will undergo a spinal stimulation using electrical stimulation as a part of their normal care. The research procedures will duplicate this with an invasive Focused Ultrasound stimulation.
Group IV: Patients receiving CraniotomyExperimental Treatment1 Intervention
Patients receiving an awake or asleep craniotomy for brain tumors and/or epilepsy will undergo a brain mapping procedure using electrical stimulation as a part of their normal care. The research procedures will duplicate this mapping with an invasive Focused Ultrasound mapping.
Group V: Epilepsy PatientsExperimental Treatment1 Intervention
Patients undergoing long term monitoring for epilepsy will receive a non-invasive form of Focused Ultrasound stimulation which will be measured by their EEG cap and intracranial electrodes which are a part of their normal care.
Find a Location
Who is running the clinical trial?
University of VirginiaLead Sponsor
753 Previous Clinical Trials
1,244,740 Total Patients Enrolled
Wynn Legon, PhDPrincipal InvestigatorUniversity of Virginia
4 Previous Clinical Trials
165 Total Patients Enrolled
Frequently Asked Questions
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