Feasibility of Using NeuraSignal Transcranial Doppler Robot

Feasibility of Using NeuraSignal Transcranial Doppler Robot for Generating Cerebral Autoregulation Curves in Neuro ICU Patients Admitted for Blood Pressure Management After Spinal Surgery

The purpose of this study is to determine the feasibility of using the NeuraSignal transcranial doppler robot in a neuro ICU setting to measure cerebral blood flow correlated with arterial blood pressure to generate individualized cerebral autoregulatory curves

Study Overview

• Status: Not yet recruiting
• Conditions: Cerebral Autoregulation
• Intervention / Treatment: Device: NeuraSignal transcranial doppler robot

Detailed Description

This study aims to explore the feasibility of using the NeuraSignal transcranial doppler robot to generate cerebral autoregulation curves in adult patients admitted to the neuro ICU with a newly diagnosed brain mass. Cerebral blood flow measurements as calculated by a transcranial doppler robot will be time-correlated with arterial blood pressure measurements to generate personalized cerebral autoregulation curves. The study will be conducted prospectively and observationally on 20 patients as a pilot study for feasibility management.

Cerebral autoregulation has historically been difficult to quantify, in part due to the difficulty in measuring cerebral blood flow directly. Transcranial doppler (TCD) is a well-established method of calculating cerebral blood flow based on velocity through the middle cerebral arteries, however traditional methods of performing TCD are time consuming and require technical and procedural training. It also carries the established risk of miscalculation with variation in intra-operator technique differences and miscalculations due to inappropriate angle of the probe. The NeuraSignal transcranial doppler robot offers a potential tool to make obtaining cerebral blood flow calculations easier and, with the use of AI to determine optimal windows, significantly decreases intra-operator differences and errors associated with inappropriate probe angle. Cerebral blood flow calculated in this way can then be correlated with arterial blood pressure and used to build cerebral autoregulatory curves in near real time. This study aims to build on previous studies deriving and using personalized cerebral autoregulatory curves and determine the feasibility of using the TCD robot in this way to make individualized cerebral autoregulatory curves more accessible as a tool for personalized blood pressure management.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Shanna Graves; Phone Number: 205-975-2845; Email: shannagraves@uabmc.edu
• Study Contact Backup: Name: LaShun Horn; Phone Number: (205) 996-2606; Email: llhorn@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • UAB Department of Anesthesiology and Perioperative Medicine
      • Contact: Shanna Graves; Phone Number: 205-975-2845; Email: shannagraves@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the Neuro ICU for blood pressure management (MAP management) after spinal surgery

Description

Inclusion Criteria:

• 18-89
• Patients admitted to the Neuro ICU for blood pressure management (MAP management) after spinal surgery

Exclusion Criteria:

• Patients under 18 years (or bodyweight <50kg if age unknown),
• prisoners
• pregnant women,
• non-English speaking,
• patients enrolled in concurrent
• ongoing interventional trial
• students of UAB
• employees of UAB
• targeting specific populations
• patients with previously diagnosed brain pathology
• patients with open wounds over temporal bones precluding transcranial doppler

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Group; Using the NeuraSignal transcranial doppler robot in a neuro ICU setting to measure cerebral blood flow correlated with arterial blood pressure to generate individualized cerebral autoregulatory curves.	Device: NeuraSignal transcranial doppler robot; measure cerebral blood flow correlated with arterial blood pressure to generate individualized cerebral autoregulatory curves

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome	Cerebral autoregulatory curve generation using the NeuraSignal transcranial doppler robot correlated with arterial blood pressure measurements in neuro ICU patients admitted for blood pressure management after spinal surgery	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary outcome	left or right shifting of the autoregulatory curve as a result of vasopressor use	one year

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Emily A Wasson, MD,MPH, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): December 14, 2026
• Study Completion (Estimated): December 15, 2027

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: IRB-300013270; UAB (Other Identifier: UAB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To be determined.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No