# Epilepsy Seizure Detection with Innovative Tripolar EEG (tEEG)

> **NIH NIH U44** · CREMEDICAL CORPORATION · 2021 · $748,550

## Abstract

PROJECT SUMMARY
Electroencephalography (EEG) is an essential component in the evaluation of epilepsy, the most common
serious brain disorder worldwide. Misdiagnosis of epilepsy is very common and occurs in up to 50% of the
patients. Artifact contamination seriously hinders the effectiveness of EEG and is a root cause of misdiagnosis.
CREmedical is developing a tripolar concentric ring electrode (TCRE) sensor and a t-Interface that registers
tripolar EEG (tEEG) and emulated EEG (eEEG). tEEG resolves the fundamental drawbacks of conventional
EEG, providing significant improvement in signal fidelity, spatial resolution, and registering of higher frequency
brain activities, where conventional EEG is lacking. There is increasing interest in the epilepsy community in
analyzing high-frequency oscillations (HFOs) for localizing epileptogenic zones.
The overall objective of this SBIR fast-track project is to complete the necessary non-clinical and clinical
activities in order to enable the transition of the device from lab to clinical use. This project integrates
multidisciplinary expertise in technology, epilepsy, neurophysiology, and regulatory affairs.
The Phase I objective is to complete the non-clinical development activities necessary for commercialization
and obtaining IRB approval for initiating a clinical trial in epilepsy.
Ph I - Milestone 1: Obtain clear non-binding indication from the FDA that our proposed clinical trial protocol is
likely sufficient to obtain a 510 (k) regulatory clearance.
Ph I - Milestone 2: Obtain IRB confirmation that the proposed pre-clinical testing and clinical protocol are
appropriate to support the non-significant risk (NSR) clinical trial.
Ph I - Milestone 3: Develop head phantom and computer simulation to test contribution of local reference.
Ph I - Milestone 4: Establish Design and Quality Systems Control process.
Ph I - Milestone 5: Perform design verification and validation in pursuant to regulatory and industry standards.
The Phase II objective is to demonstrate the safety and efficacy of the tEEG device in recording electrical
brain activities in persons with epilepsy in preparation for obtaining FDA clearance.
Ph II – Milestone 1: Proven usability. (A) Do EEG technologists have problems applying and removing the
TCREs? (B) Are the tEEG and eEEG data interpretable? (C) Can tEEG and eEEG record patterns that are
also visible with concurrent conventional EEG?
Ph II – Milestone 2: Superiority of tEEG for artifacts suppression.
Ph II – Milestone 3: Superiority of tEEG for seizure detection.
Ph II – Milestone 4: Comparison between simultaneous intracranial recordings and tEEG for seizure
localization.

## Key facts

- **NIH application ID:** 10200485
- **Project number:** 1U44NS121559-01
- **Recipient organization:** CREMEDICAL CORPORATION
- **Principal Investigator:** Walter Grant Besio
- **Activity code:** U44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $748,550
- **Award type:** 1
- **Project period:** 2021-08-01 → 2024-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10200485

## Citation

> US National Institutes of Health, RePORTER application 10200485, Epilepsy Seizure Detection with Innovative Tripolar EEG (tEEG) (1U44NS121559-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10200485. Licensed CC0.

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