Back to resultsNeurocognitive Dysfunction After Anesthesia in Patients With Recent Concussion
Primary Purpose
Concussion, Brain
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neurocognitive Testing
Sponsored by
About this trial
This is an interventional basic science trial for Concussion, Brain
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Concussion Group
Matched Subjects Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Wide Range Achievement Test Fourth Edition, WRAT-4
Change in WRAT-4
Secondary Outcome Measures
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.
Oral morphine equivalent of consumed opioids
Difference of post-operative opioid use between the concussion and non-concussion group
Length of hospital stay
Difference between the concussion and non-concussion group
Cognitive Deficits identified by NeuroPsychometric Cognitive Testing
Difference between the concussion and non-concussion group.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03952208
Brief Title
Neurocognitive Dysfunction After Anesthesia in Patients With Recent Concussion
Official Title
Neurocognitive Dysfunction After Anesthesia in Patients With Recent Concussion
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 21, 2019 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Researchers are trying to determine if the impact of a concussion on the brain is affected by anesthesia and surgery.
Detailed Description
All subjects will complete pre and post procedure assessments prior to undergoing a planned surgery/anesthetic standard of care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Brain
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Concussion Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Matched Subjects Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Neurocognitive Testing
Intervention Description
A comprehensive assessment of neuropsychometric measures to evaluate cognitive functioning.
Primary Outcome Measure Information:
Title
Wide Range Achievement Test Fourth Edition, WRAT-4
Description
Change in WRAT-4
Time Frame
Pre-anesthetic to one week Post-anesthetic
Secondary Outcome Measure Information:
Title
Numeric Pain Scale 0-10
Description
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.
Title
Oral morphine equivalent of consumed opioids
Description
Difference of post-operative opioid use between the concussion and non-concussion group
Time Frame
Post-operatively to hospital discharge, up to 10 days.
Title
Length of hospital stay
Description
Difference between the concussion and non-concussion group
Time Frame
Post-operatively to hospital discharge, up to 30 days.
Title
Cognitive Deficits identified by NeuroPsychometric Cognitive Testing
Description
Difference between the concussion and non-concussion group.
Time Frame
Pre-anesthetic to one week Post-anesthetic
Title
Sport Concussion Assessment Tool - 5th edition, SCAT-5
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnoley S Abcejo, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Neurocognitive Dysfunction After Anesthesia in Patients With Recent Concussion
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