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CompletedNCT03952208Updated Apr 16, 2025

Neurocognitive Dysfunction After Anesthesia in Patients With Recent Concussion

An interventional study of Neurocognitive Testing in Concussion, Brain, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-16.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Non-randomized
Ages
16 Years and older
Sex
All
01

Study summary

Researchers are trying to determine if the impact of a concussion on the brain is affected by anesthesia and surgery.

Read the detailed description

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

02

Conditions studied

  • Concussion, Brain
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In context

Brain Concussion

530 studies on the registry are indexed under Brain Concussion; 151 are open to participants now.

This study's enrollment of 52 is below the median of 64 across 364 interventional studies indexed under Brain Concussion.

Browse Brain Concussion studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Neurologic history including history of severe cognitive disease, disorder, or delay, attention disorder, moderate to severe TBI history, neurovascular order or trauma.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherNeurocognitive Testing

    A comprehensive assessment of neuropsychometric measures to evaluate cognitive functioning.

06

What researchers measure

Primary outcomes

  1. Wide Range Achievement Test Fourth Edition, WRAT-4

    Change in WRAT-4

    Time frame: Pre-anesthetic to one week Post-anesthetic

Secondary outcomes

  1. Numeric Pain Scale 0-10

    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.

    Time frame: Post-operatively to hospital discharge, up to 10 days.

  2. Oral morphine equivalent of consumed opioids

    Difference of post-operative opioid use between the concussion and non-concussion group

    Time frame: Post-operatively to hospital discharge, up to 10 days.

  3. Length of hospital stay

    Difference between the concussion and non-concussion group

    Time frame: Post-operatively to hospital discharge, up to 30 days.

  4. Cognitive Deficits identified by NeuroPsychometric Cognitive Testing

    Difference between the concussion and non-concussion group.

    Time frame: Pre-anesthetic to one week Post-anesthetic

  5. Sport Concussion Assessment Tool - 5th edition, SCAT-5

    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).

    Time frame: Pre-anesthetic to one week Post-anesthetic

07

Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03952208
Lead sponsor
Mayo Clinic
Responsible party
Arnoley (Arney) S. Abcejo (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
May 16, 2019
Start date
Feb 21, 2019
Primary completion
Mar 1, 2023
Completion
Apr 10, 2025
Last update
Apr 16, 2025

Study contacts

Arnoley S Abcejo, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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