Feasibility of Using NeuraSignal Transcranial Doppler Robot

NCT ID: NCT06565442

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-02-15

Study Completion Date

2027-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Autoregulation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

NeuraSignal transcranial doppler robot

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NeuraSignal transcranial doppler robot

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Emily Wasson

MD, MPH Assistant Professor Division of Critical Care Department of Anesthesiology and Perioperative Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Emily A Wasson, MD,MPH

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UAB Department of Anesthesiology and Perioperative Medicine

Birmingham, Alabama, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Shanna Graves

Role: CONTACT

Phone: 205-975-2845

Email: [email protected]

LaShun Horn

Role: CONTACT

Phone: (205) 996-2606

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Shanna Graves

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UAB

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-300013270

Identifier Type: -

Identifier Source: org_study_id