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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-operatively to hospital discharge, up to 10 days.
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-operatively to hospital discharge, up to 10 days.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-operatively to hospital discharge, up to 10 days.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Wide Range Achievement Test Fourth Edition, WRAT-4
Secondary outcome measures
Cognitive Deficits identified by NeuroPsychometric Cognitive Testing
Length of hospital stay
Numeric Pain Scale 0-10
+2 moreTrial 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.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,732 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: Concussion Group
- Group 2: Matched Subjects 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research initiative still recruiting participants?
"Affirmative. Clinicaltrials.gov data reveals that this study began on February 21st, 2019 and has been actively searching for 60 patients from a single site since the trial's last update on May 1st 2022."
Answered by AI
How many individuals have participated in this clinical trial thus far?
"Affirmative. Clinicaltrials.gov hosts data which confirms that this trial, first established on February 21st 2019, is now actively seeking participants. 60 patients must be sourced from a single medical facility."
Answered by AI
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