52 Participants Needed

Anesthesia's Impact on Neurocognitive Function After Concussion

BA
AL
Overseen ByAmy L Amsbaugh
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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

Research Team

AS

Arnoley S Abcejo, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

I am over 16 and had a concussion less than 10 weeks ago from a planned procedure.

Exclusion 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.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-procedure Assessment

Participants undergo neurocognitive testing before the planned surgery/anesthetic

1 week
1 visit (in-person)

Procedure

Participants undergo planned surgery/anesthetic standard of care

1 day
1 visit (in-person)

Post-procedure Assessment

Participants undergo neurocognitive testing after the surgery/anesthetic

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Neurocognitive Testing
Trial Overview 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
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Recruited
3,221,000+
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