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Neurocognitive Dysfunction After Anesthesia in Patients With Recent Concussion

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ClinicalTrials.gov Identifier: NCT03952208
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Arnoley (Arney) S. Abcejo, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Concussion, Brain Other: Neurocognitive Testing Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Neurocognitive Dysfunction After Anesthesia in Patients With Recent Concussion
Actual Study Start Date : February 21, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

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.




Primary Outcome Measures :
  1. Wide Range Achievement Test Fourth Edition, WRAT-4 [ Time Frame: Pre-anesthetic to one week Post-anesthetic ]
    Change in WRAT-4


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. Length of hospital stay [ Time Frame: Post-operatively to hospital discharge, up to 30 days. ]
    Difference between the concussion and non-concussion group

  4. Cognitive Deficits identified by NeuroPsychometric Cognitive Testing [ Time Frame: Pre-anesthetic to one week Post-anesthetic ]
    Difference between the concussion and non-concussion group.

  5. 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).



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952208


Contacts
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Contact: Amy L Amsbaugh 507-538-7538 amsbaugh.amy@mayo.edu
Contact: Brenda Anderson 507-255-7157 anderson.brenda@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Amy L Amsbaugh         
Principal Investigator: Arnoley S Abcejo, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Arnoley S Abcejo, MD Mayo Clinic

Additional Information:
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Responsible Party: Arnoley (Arney) S. Abcejo, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03952208     History of Changes
Other Study ID Numbers: 18-006578
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cognitive Dysfunction
Brain Concussion
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
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