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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how anesthesia (medication that induces sleep during surgery) and surgery affect the brain after a concussion. Participants will undergo neurocognitive testing (brain function tests) before and after surgery. The trial includes two groups: one with individuals who have experienced a concussion and another with those who have not but are undergoing similar surgeries. Candidates may qualify if they have had a concussion in the past 10 weeks and are planning surgery with anesthesia. As an unphased trial, this study provides a unique opportunity to contribute to understanding the effects of anesthesia on brain recovery following a concussion.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. It's best to ask the trial coordinators for more details.

What prior data suggests that neurocognitive testing is safe for assessing anesthesia's impact on concussion?

Research has shown that neurocognitive tests, like those used in this trial, are generally safe for participants. These tests assess brain function, often following events such as a concussion.

While the tests themselves are safe, studies have found that surgery and anesthesia can sometimes impair brain function. For instance, some research indicated that after surgery, individuals with a concussion might experience more difficulties with thinking and memory than those who do not undergo surgery.

It is important to note that not everyone will experience these issues; this highlights a potential risk. The tests in this trial help researchers understand how anesthesia and surgery might affect brain function after a concussion. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how anesthesia might impact neurocognitive function after a concussion. Unlike standard care, which typically focuses on direct treatment of concussion symptoms through rest and gradual return to activities, this trial investigates the potential cognitive changes that anesthesia might bring in post-concussion scenarios. By using neurocognitive testing before and after surgery, the study aims to uncover whether anesthesia contributes to cognitive differences in those with concussions compared to those without. This could lead to more informed decisions regarding surgical care in patients with recent concussions.

What evidence suggests that neurocognitive testing is effective for assessing the impact of anesthesia on brain function after a concussion?

Research shows that anesthesia, the medicine used to prevent pain during surgery, might affect the brain differently in people who have had a concussion. This trial divides participants into two groups: the Concussion Group, consisting of subjects diagnosed with a concussion, and the Matched Subjects Group, consisting of subjects without a concussion. Studies have found that people with brain injuries, like concussions, may experience more changes in thinking and memory after surgery with anesthesia compared to those without such injuries. Evidence suggests that anesthesia might contribute to these changes, especially in those with recent brain injuries. This ongoing research aims to better understand these effects and how they might impact recovery. ^{3 4 6 7 8}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12189922/

Neurocognitive Outcomes After Extracranial Surgery and ... This study investigated whether individuals with mild-to-moderate traumatic brain injury (TBI) are at increased risk of neurocognitive ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2839926

One-Year Outcomes After Traumatic Brain Injury and Early ... The results of this study demonstrate an association between early EC surgery after TBI and worse functional, cognitive, and disability outcomes ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03952208

Neurocognitive Dysfunction After Anesthesia in Patients ... Researchers are trying to determine if the impact of a concussion on the brain is affected by anesthesia and surgery. Detailed Description. All subjects will ...

4. mdpi.com mdpi.com/2079-7737/14/6/640/review_report

Neurocognitive Outcomes After Extracranial Surgery and ... Khan et al have provided exciting systematic review and meta-analysis study which summarizes the neurocognitive outcomes after extracranial surgery and GA

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7000285/

Anesthesia for the patient with a recently diagnosed ... Effects of anesthesia on outcome in patients with concussion​​ Anesthetic management has the potential to have a significant impact on outcome in concussed ...

6. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2813029

Clinical Outcomes After Traumatic Brain Injury and ... Extracranial surgery and anesthesia were associated with worse functional and cognitive outcomes at 2 weeks and 6 months after injury.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10719833/

Clinical Outcomes After Traumatic Brain Injury and Exposure ... The findings support an association between exposure to extracranial surgery and anesthesia and worse outcomes after TBI in both functional and ...

8. withpower.com withpower.com/trial/phase-cognitive-dysfunction-1-2019-8168d

Anesthesia's Impact on Neurocognitive Function After ... 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.