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
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Brain Concussion
• Cognitive Dysfunction
• Concussion, Brain

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