Anesthesia's Impact on Neurocognitive Function After Concussion

Overseen By Amy L Amsbaugh

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Severe cognitive disease, Attention disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

52 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Arnoley S Abcejo, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Matched Subjects Group Experimental Treatment 1 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 Group Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+