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Developing a novel system combining cognitive assessment with PASCALL FDA-cleared intraoperative anesthesia EEG brain monitor to prevent postoperative neurocognitive disorders in aging patients

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R42AG084399-01
Agency Tracking Number: R42AG084399
Amount: $299,893.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIA
Solicitation Number: PAS22-197
Timeline
Solicitation Year: 2022
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-09-30
Award End Date (Contract End Date): 2024-06-30
Small Business Information
200 PORTLAND ST FL 5
Boston, MA 02114-1722
United States
DUNS: 116842769
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 TUAN LEMAU
 (617) 982-4274
 tuan@pascallsystems.com
Business Contact
 TUAN LE MAU
Phone: (617) 982-4274
Email: tuan@pascallsystems.com
Research Institution
 MASSACHUSETTS GENERAL HOSPITAL
 
55 FRUIT STREET
BOSTON, MA 02114-2621
United States

 Domestic Nonprofit Research Organization
Abstract

Each day, more than 100,000 patients undergo general anesthesia in the United States. The
current practice of general anesthesia is prone to over-sedating patients, either due to the lack of
brain monitoring or using brain monitors with inaccurate indices. Over-sedation (at 28% incidence)
contributes to perioperative neurocognitive disorders (PNDs) in elderly population (≥65yrs). The
cost of PND is enormous to the healthcare system, at least $70B in healthcare expenditures
annually in the United State with the long-term healthcare cost at $44M per patient per case per
year.
PASCALL mission is to improve personalized anesthesia across peri- and intra-operative care.
Intraoperatively, supported by NIA sister grant AG066325, we developed PASCALL Wireless
EEG monitoring system (M0) for the operating room (OR) to improve anesthesia management,
reduce over-sedation and reduce long-term PND. Our system received FDA clearance in May
2022.
This grant project proposes a significant innovation that combines perioperative cognitive
assessment with intraoperative monitoring using PASCALL FDA-cleared monitor to enable timely
anesthesia care and effective monitoring of PNDs. PASCALL realizes this innovation through
three (3) specific aims:
(Aim 1) To develop Perioperative Monitoring of Neurocognitive Disorders test battery
(pMiND) and integrate with Pascall FDA-cleared Wireless EEG system (PASCALL M0)
(Aim 2) To develop an algorithm to identify surgical patients at greater risk of post-
operative delirium and
(Aim 3) To develop and integrate a measure to estimate intra-operative anesthetic
requirements to brain monitoring systems in the operating room (OR) into Pascall FDA-
cleared Wireless EEG system (M0)
Although there are a multitude of current cognitive assessment products, none were designed for
perioperative monitoring (Aim 1) nor able to provide at-risk score and anesthetic requirement to
an intraoperative monitoring system (Aim 2-3).
The success of this novel project will make pre-operative cognitive assessment easy to
administer. The contribution of this project is to shift current practices of general anesthesia
towards more personalized patient care, especially for patients’ population at risk with PND. The
proposed project is innovative because it combines preoperative cognitive assessment with
intraoperative brain state monitoring. The cognitive assessment is designed for reliability and
usability to fit the fast-paced surgery workflow and highly specific to the identification and
reduction of PND in elderly patients.

* Information listed above is at the time of submission. *

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