Neurocognitive Dysfunction After Anesthesia in Patients With Recent Concussion

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

Study Overview

• Status: Active, not recruiting
• Conditions: Concussion, Brain
• Intervention / Treatment: Other: Neurocognitive Testing

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

• Study Contact: Name: Amy L Amsbaugh; Phone Number: 507-538-7538; Email: amsbaugh.amy@mayo.edu
• Study Contact Backup: Name: Brenda Anderson; Phone Number: 507-255-7157; Email: anderson.brenda@mayo.edu

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	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	Difference between the concussion and non-concussion group	Post-operatively to hospital discharge, up to 30 days.
Cognitive Deficits identified by NeuroPsychometric Cognitive Testing	Difference between the concussion and non-concussion group.	Pre-anesthetic to one week Post-anesthetic
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).	Pre-anesthetic to one week Post-anesthetic

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2019
• Primary Completion (Actual): March 1, 2023
• Study Completion (Anticipated): March 1, 2024

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): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Neurocognitive Disorders; Craniocerebral Trauma; Trauma, Nervous System; Cognition Disorders; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Cognitive Dysfunction; Brain Concussion
• 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