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Anesthesia's Impact on Neurocognitive Function After Concussion
N/A
Waitlist Available
Led By Arnoley S Abcejo, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must not have
Neurologic history including history of severe cognitive disease, disorder, or delay
History of neurovascular order or trauma.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-operatively to hospital discharge, up to 10 days.
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if anesthesia affects the brain differently in people who have had a concussion.
Who is the study for?
This trial is for men and women over the age of 16 who have had a concussion within the last 10 weeks and are scheduled for a procedure that requires anesthesia. It's not open to those with severe cognitive diseases, moderate to severe traumatic brain injury (TBI), attention disorders, or past neurovascular trauma.
What is being tested?
The study aims to assess how anesthesia and surgery might affect brain function after a recent concussion. Participants will undergo neurocognitive testing before and after their procedures to measure any changes.
What are the potential side effects?
Since this trial involves standard medical procedures rather than new medications, side effects are related to typical risks associated with anesthesia such as nausea, drowsiness, sore throat, confusion or memory issues post-surgery.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of severe cognitive or neurological conditions.
Select...
I have had a stroke or brain injury.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-operatively to hospital discharge, up to 30 days.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-operatively to hospital discharge, up to 30 days.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Wide Range Achievement Test Fourth Edition, WRAT-4
Secondary study objectives
Cognitive Deficits identified by NeuroPsychometric Cognitive Testing
Length of hospital stay
Numeric Pain Scale 0-10
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Matched Subjects GroupExperimental Treatment1 Intervention
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.
Group II: Concussion GroupExperimental Treatment1 Intervention
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.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,339 Previous Clinical Trials
3,062,093 Total Patients Enrolled
Arnoley S Abcejo, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of severe cognitive or neurological conditions.You have had a significant head injury in the past.I have had a stroke or brain injury.I am over 16 and had a concussion less than 10 weeks ago from a planned procedure.You have been diagnosed with attention disorder in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Matched Subjects Group
- Group 2: Concussion Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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