Concussion, BrainNCT03952208
Neurocognitive Dysfunction After Anesthesia in Patients With Recent Concussion
A study testing Neurocognitive Testing in people with Concussion, Brain, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to determine if the impact of a concussion on the brain is affected by anesthesia and surgery. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Concussion, Brain
- What is being tested?
- Neurocognitive Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2019to 10 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male or Female >16 years of age with a recent concussion (<10 weeks) from planned procedure under anesthesia.
Who cannot join
- Neurologic history including history of severe cognitive disease, disorder, or delay, attention disorder, moderate to severe TBI history, neurovascular order or trauma.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Researchers are trying to determine if the impact of a concussion on the brain is affected by anesthesia and surgery.
Read the detailed description
All subjects will complete pre and post procedure assessments prior to undergoing a planned surgery/anesthetic standard of care.
- Conditions
- Concussion, Brain
- Being tested
- Neurocognitive Testing
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurocognitive TestingOther
A comprehensive assessment of neuropsychometric measures to evaluate cognitive functioning.
| Study group | Role | What they receive |
|---|---|---|
| Concussion Group | Experimental | 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. Receives: Other: Neurocognitive Testing |
| Matched Subjects Group | Experimental | 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. Receives: Other: Neurocognitive Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wide Range Achievement Test Fourth Edition, WRAT-4
Change in WRAT-4
Measured: Pre-anesthetic to one week Post-anesthetic
Secondary outcomes (5)
Numeric Pain Scale 0-10
Difference in numeric pain scale between the concussion and non-concussion group. Patients verbally select a value that is in line with the intensity of pain they have experienced in the last 24 hours. Pain Scale is recorded "0" = no pain, "10" = the most pain imaginable.
Measured: Post-operatively to hospital discharge, up to 10 days.
Oral morphine equivalent of consumed opioids
Difference of post-operative opioid use between the concussion and non-concussion group
Measured: Post-operatively to hospital discharge, up to 10 days.
Length of hospital stay
Difference between the concussion and non-concussion group
Measured: Post-operatively to hospital discharge, up to 30 days.
Cognitive Deficits identified by NeuroPsychometric Cognitive Testing
Difference between the concussion and non-concussion group.
Measured: Pre-anesthetic to one week Post-anesthetic
Sport Concussion Assessment Tool - 5th edition, SCAT-5
The SCAT5 is a standardized tool for evaluating concussions designed for use by physicians and licensed medical professionals. Difference in SCAT5 scores between the concussion and non-concussion group. SCAT5 scores the number of symptoms (0-22) present and the severity of symptoms (0-132).
Measured: Pre-anesthetic to one week Post-anesthetic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start21 Feb 2019
- Primary completion1 Mar 2023
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnoley (Arney) S. Abcejo, Mayo Clinic
- Investigators
- Arnoley S Abcejo, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952208
- Sponsor's protocol ID
- 18-006578
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2019
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Dysfunction After Anesthesia in Patients With Recent Concussion
- ClinicalTrials.gov ID
- NCT03952208
- Acronym / sponsor ID
- 18-006578
- Conditions
- Concussion, Brain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 16 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 complete pre and post procedure assessments prior to undergoing a planned surgery/anesthetic standard of care.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concussion Group | Experimental | Other: Neurocognitive TestingSubjects 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. |
| Matched Subjects Group | Experimental | Other: Neurocognitive TestingMatched 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Male or Female >16 years of age with a recent concussion (<10 weeks) from planned procedure under anesthesia.
Key exclusion criteria (1 listed)
- Neurologic history including history of severe cognitive disease, disorder, or delay, attention disorder, moderate to severe TBI history, neurovascular order or trauma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurocognitive TestingA comprehensive assessment of neuropsychometric measures to evaluate cognitive functioning. | Other | Concussion Group, Matched Subjects Group |
Primary outcome
Wide Range Achievement Test Fourth Edition, WRAT-4
Time frame: Pre-anesthetic to one week Post-anesthetic
Change in WRAT-4
5 secondary outcomes
Numeric Pain Scale 0-10
Time frame: Post-operatively to hospital discharge, up to 10 days.
Oral morphine equivalent of consumed opioids
Time frame: Post-operatively to hospital discharge, up to 10 days.
Length of hospital stay
Time frame: Post-operatively to hospital discharge, up to 30 days.
Cognitive Deficits identified by NeuroPsychometric Cognitive Testing
Time frame: Pre-anesthetic to one week Post-anesthetic
Sport Concussion Assessment Tool - 5th edition, SCAT-5
Time frame: Pre-anesthetic to one week Post-anesthetic
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnoley S Abcejo, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurocognitive Testing in people with Concussion, Brain, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wide Range Achievement Test Fourth Edition, WRAT-4 (time frame: Pre-anesthetic to one week Post-anesthetic). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.