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Intra-operative brain tonometry for Tuberous Sclerosis
N/A
Waitlist Available
Led By Aria Fallah, MD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with epilepsy who candidates for surgical treatment as established by a multidisciplinary committee specialized in epilepsy.
Participants undergoing resective surgery for epilepsy of dysplastic (examples: focal cortical dysplasia, tuberous sclerosis, hemimegalencephaly, polymicrogyria) or non-dysplastic etiology (examples: developmental tumors, gliosis, stroke, Rasmussen encephalitis, Sturge-Weber syndrome).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 36 months
Awards & highlights
Study Summary
This trial is testing a new way to help surgeons more accurately find and remove the part of the brain causing seizures in people with epilepsy that doesn't respond to medication.
Eligible Conditions
- Tuberous Sclerosis
- Polymicrogyria
- Gliosis
- Rasmussen Syndrome
- Epilepsy
- Focal Cortical Dysplasia
- Hemimegalencephaly
- Sturge-Weber Syndrome
- Brain Tumor
- Stroke
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brain tissue stiffness measurements in mmHg as assessed by intraoperative use of a digital tonometer on presumed normal cerebral cortex
Brain tissue stiffness measurements in mmHg as assessed by intraoperative use of a digital tonometer on presumed pathological cerebral cortex
Correlation between brain tissue stiffness measurements in mmHg as assessed by novel intraoperative use of a digital tonometer and results of standard perioperative evaluations, using a 3D model of each brain
Secondary outcome measures
Seizure freedom as assessed clinically on standard postoperative follow-up through study completion, up to 36 months
Surgical complications as assessed clinically on standard postoperative follow-up through study completion, up to 36 months
Trial Design
1Treatment groups
Experimental Treatment
Group I: Brain tonometryExperimental Treatment1 Intervention
Participants undergoing intra-operative brain tissue stiffness measurements using a digital tonometer. Evaluated brain tissue is both presumed normal and abnormal based on results of pre-operative evaluations.
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,523 Previous Clinical Trials
10,279,364 Total Patients Enrolled
4 Trials studying Tuberous Sclerosis
212 Patients Enrolled for Tuberous Sclerosis
Université de MontréalOTHER
211 Previous Clinical Trials
102,284 Total Patients Enrolled
Aria Fallah, MD3.73 ReviewsPrincipal Investigator - University of California, Los Angeles
University of California, Los Angeles
5Patient Review
We are beyond grateful for Dr. Fallah. Our son has not had a seizure in over a year, and this is thanks to him and his team. With the exception of the day of our son's surgery, we've only interacted with Dr. Fallah through telehealth. Even so, he has always been kind, professional, and courteous. He also always answers our questions and concerns promptly and thoroughly.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have been enrolled in this experiment?
"Affirmative. Information hosted on clinicaltrials.gov suggests that this experiment, which was initially posted on July 16th 2018, is actively seeking participants. Around 150 individuals must be recruited from 2 different medical facilities."
Answered by AI
Are there vacant slots left for participants in this experiment?
"The trial is still recruiting patients, with records of the original posting on July 16th 2018 and a recent update from April 9th 2020."
Answered by AI
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