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NCT Number: NCT06565442

Feasibility of Using NeuraSignal Transcranial Doppler Robot

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

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UAB Department of Anesthesiology and Perioperative Medicine

Birmingham, Alabama, 35249, United States

Location contact

Shanna Graves

CONTACT

[email protected]

205-975-2845

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NeuraSignal transcranial doppler robot

Device

measure cerebral blood flow correlated with arterial blood pressure to generate individualized cerebral autoregulatory curves

Primary outcomes

  1. Primary outcome

    Time frame: one year

    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

Secondary outcomes

  1. Secondary outcome

    Time frame: one year

    left or right shifting of the autoregulatory curve as a result of vasopressor use

Study contacts

Contact information is provided by the study sponsor or research team.

LaShun Horn

CONTACT

[email protected]

(205) 996-2606

Shanna Graves

CONTACT

[email protected]

205-975-2845

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 22, 2024
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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