Neurocognitive Dysfunction After Anesthesia in Patients With Recent Concussion

April 11, 2025 updated by: Arnoley (Arney) S. Abcejo, Mayo Clinic
Researchers are trying to determine if the impact of a concussion on the brain is affected by anesthesia and surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All subjects will complete pre and post procedure assessments prior to undergoing a planned surgery/anesthetic standard of care.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male or Female >16 years of age with a recent concussion (<10 weeks) from planned procedure under anesthesia.

Exclusion Criteria:

  • Neurologic history including history of severe cognitive disease, disorder, or delay, attention disorder, moderate to severe TBI history, neurovascular order or trauma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Concussion Group
Subjects diagnosed with concussion defined as a clinician-diagnosed disease by the International Classification of Diseases (ICD)-10 due to a head injury with a Glasgow Coma Score ≥13 undergoing a planned surgery/anesthetic standard of care will undergo neurocognitive testing pre and post surgery/anesthetic.
Other: Neurocognitive Testing
A comprehensive assessment of neuropsychometric measures to evaluate cognitive functioning.
Experimental: Matched Subjects Group
Matched subjects without concussion undergoing a planned surgery/anesthetic standard of care, matching for procedural type, sex, age ± 2 years, and adherence to the exclusion criteria will undergo neurocognitive testing pre and post surgery/anesthetic.
Other: Neurocognitive Testing
A comprehensive assessment of neuropsychometric measures to evaluate cognitive functioning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wide Range Achievement Test Fourth Edition, WRAT-4
Time Frame: Pre-anesthetic to one week Post-anesthetic
Change in WRAT-4
Pre-anesthetic to one week Post-anesthetic

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Scale 0-10
Time Frame: Post-operatively to hospital discharge, up to 10 days.
Difference in numeric pain scale between the concussion and non-concussion group. Patients verbally select a value that is in line with the intensity of pain they have experienced in the last 24 hours. Pain Scale is recorded "0" = no pain, "10" = the most pain imaginable.
Post-operatively to hospital discharge, up to 10 days.
Oral morphine equivalent of consumed opioids
Time Frame: Post-operatively to hospital discharge, up to 10 days.
Difference of post-operative opioid use between the concussion and non-concussion group
Post-operatively to hospital discharge, up to 10 days.
Length of hospital stay
Time Frame: Post-operatively to hospital discharge, up to 30 days.
Difference between the concussion and non-concussion group
Post-operatively to hospital discharge, up to 30 days.
Cognitive Deficits identified by NeuroPsychometric Cognitive Testing
Time Frame: Pre-anesthetic to one week Post-anesthetic
Difference between the concussion and non-concussion group.
Pre-anesthetic to one week Post-anesthetic
Sport Concussion Assessment Tool - 5th edition, SCAT-5
Time Frame: Pre-anesthetic to one week Post-anesthetic
The SCAT5 is a standardized tool for evaluating concussions designed for use by physicians and licensed medical professionals. Difference in SCAT5 scores between the concussion and non-concussion group. SCAT5 scores the number of symptoms (0-22) present and the severity of symptoms (0-132).
Pre-anesthetic to one week Post-anesthetic

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Arnoley S Abcejo, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2019

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

April 10, 2025

Study Registration Dates

First Submitted

April 9, 2019

First Submitted That Met QC Criteria

May 14, 2019

First Posted (Actual)

May 16, 2019

Study Record Updates

Last Update Posted (Actual)

April 16, 2025

Last Update Submitted That Met QC Criteria

April 11, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-006578

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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