Brain Interchange System for Aura

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Baylor College of Medicine, Houston, TX
Aura
Brain Interchange System - Device
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

Overall, this study will investigate the functional utility of stereotyped HFOs by capturing them with a new implantable system (Brain Interchange - BIC of CorTec), which can sample neural data at higher rates >=1kHz and deliver targeted electrical stimulation to achieve seizure control. In contrast to current closed-loop systems (RNS), which wait for the seizure to start before delivering stimulation, the BIC system will monitor the spatial topography and rate of stereotyped HFOs and deliver targeted stimulation to these HFO generating areas to prevent seizures from occurring. If the outcomes of our research in an acute setting become successful, the investigators will execute a clinical trial and run the developed methods with the implantable BIC system in a chronic ambulatory setting.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: In the 4th and 5th years of the project

In the 4th and 5th years of the project
Feasibility of Delivering Closed-Loop Stimulation
Hour 24
Robustness in Data Transmission
Year 3
Feasibility of Detection of Stereotyped HFOs

Trial Safety

Trial Design

1 Treatment Group

Epilepsy
1 of 1
Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Brain Interchange System · No Placebo Group · Phase < 1

Epilepsy
Device
Experimental Group · 1 Intervention: Brain Interchange System · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: in the 4th and 5th years of the project
Closest Location: Baylor College of Medicine · Houston, TX
Photo of baylor college of medicine 1Photo of baylor college of medicine 2Photo of baylor college of medicine 3
2003First Recorded Clinical Trial
0 TrialsResearching Aura
802 CompletedClinical Trials

Who is running the clinical trial?

CorTec GmbHUNKNOWN
Baylor College of MedicineOTHER
910 Previous Clinical Trials
5,981,746 Total Patients Enrolled
University of HoustonLead Sponsor
122 Previous Clinical Trials
39,133 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,239 Previous Clinical Trials
450,552 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have medically refractory epilepsy, and are deemed appropriate candidates for intracranal EEG monitoring.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.