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NCT03952208 Clinical Trial

Neurocognitive Dysfunction After Anesthesia in Patients With Recent Concussion

Concussion, Brain Clinical Trial

Official title:
Neurocognitive Dysfunction After Anesthesia in Patients With Recent Concussion

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03952208
Other study ID # 18-006578
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 21, 2019
Est. completion date March 2025

Study information
Verified date April 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 52
Est. completion date March 2025
Est. primary completion date March 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Neurocognitive Testing
A comprehensive assessment of neuropsychometric measures to evaluate cognitive functioning.

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Wide Range Achievement Test Fourth Edition, WRAT-4 Change in WRAT-4 Pre-anesthetic to one week Post-anesthetic
Secondary 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.
Secondary 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.
Secondary Length of hospital stay Difference between the concussion and non-concussion group Post-operatively to hospital discharge, up to 30 days.
Secondary Cognitive Deficits identified by NeuroPsychometric Cognitive Testing Difference between the concussion and non-concussion group. Pre-anesthetic to one week Post-anesthetic
Secondary 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
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