Neurocognitive Dysfunction After Anesthesia in Patients With Recent Concussion

NCT03952208 | Completed

• 1 other identifier: 18-006578
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Concussion, Brain

Outcome Measures

Primary Outcomes (1)

• Wide Range Achievement Test Fourth Edition, WRAT-4

  Change in WRAT-4

  Pre-anesthetic to one week Post-anesthetic

Secondary Outcomes (5)

• Numeric Pain Scale 0-10

  Post-operatively to hospital discharge, up to 10 days.

• Oral morphine equivalent of consumed opioids

  Post-operatively to hospital discharge, up to 10 days.

• Length of hospital stay

  Post-operatively to hospital discharge, up to 30 days.

• Cognitive Deficits identified by NeuroPsychometric Cognitive Testing

  Pre-anesthetic to one week Post-anesthetic

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

  Pre-anesthetic to one week Post-anesthetic

Study Arms (2)

Concussion Group

EXPERIMENTAL

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

Matched Subjects Group

EXPERIMENTAL

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

Neurocognitive Testing OTHER

A comprehensive assessment of neuropsychometric measures to evaluate cognitive functioning.

Concussion Group; Matched Subjects Group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Arnoley S Abcejo, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: May 16, 2019
• Study Start: February 21, 2019
• Primary Completion: March 1, 2023
• Study Completion: April 10, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

US (1)