Sports ConcussionPhase 1/2REPAIRNCT01321151
Use of Resveratrol to Decrease Acute Secondary Brain Injury Following Sports-Related Concussions in Boxers
A Phase 1/2 study testing Resveratrol in people with Sports Concussion, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Sports-related concussions are a serious problem in football, boxing, and other full contact sports. After experiencing consecutive concussions, there is an increase in neurological deficits that can lead to long-term cognitive problems (Dementia pugilistica). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Sports Concussion
- What is being tested?
- Resveratrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Nov 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Boxers between the ages 18-35 years old
- Both men and women
- Boxers with an estimated concussion (Mild and Moderate) as estimated by the on-site physician or athletic trainer
- Subject has provided full written informed consent prior to the performance of any protocol-specified procedure
Who cannot join
- Immediate hospitalization for sports-related concussion (Severe Concussion)
- Known inclusion in an interventional clinical trial
- Patients with metal implants that would interfere with the MRI scan
- Known anemia
- Known Pregnancy
- Known history of alcohol/drug abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: Use of Resveratrol to Decrease Secondary Brain Injury Following Sports-Related Concussions: a Double-Blind, Placebo-Controlled Study
Sports-related concussions are a serious problem in football, boxing, and other full contact sports. After experiencing consecutive concussions, there is an increase in neurological deficits that can lead to long-term cognitive problems (Dementia pugilistica). To combat this increase in brain damage, novel strategies need to be developed to protect athletes that are participating in these full contact sports. The purpose of this study is to elucidate whether resveratrol decreases brain injury and improves brain function after experiencing a concussion in boxers.
Read the detailed description
Each year, approximately 3 million sports-related concussions occur in athletes. Only about 5% of these concussions are treated in the hospital setting. To date, there are no effective interventions used at decreasing the levels of oxidant injury and inflammation within these athletes. The standard form of care in these athletes is usually rest and light exercise for 1 -2 weeks, before returning to the sport. Within this brain injury population, administration of a neuro-protectant agent immediately following the concussion may alleviate or prevent secondary injury and subsequent development of long-term cognitive deficits such as Chronic Traumatic Encephalopathy (CTE) and Dementia pugilistica (DP). Since sports-related concussions are a serious problem in our youth, by using safe interventions, we believe that the levels of oxidant injury and brain inflammation will be decreased. In addition, these neuro-protective agents may improve cognition in these boxers, and decrease the incidence of DP.
Following brain injury, the secondary injury that immediately follows consists of heightened damage by oxygen radicals, which in turn damages vital lipids, proteins, and nucleic acids. This damage is exacerbated by highly acidic conditions with lead to the release of iron and the production of more harmful oxygen radicals. An increase in these oxygen radicals has been observed from minutes to hours within the primary injury. In addition, there is an increase in inflammation as well as excitotoxicity in the brain after traumatic injury. To combat this secondary injury, the use of anti-oxidants in individuals is warranted to decrease the amount of brain damage and cognitive decline after experiencing a severe brain injury. For example, resveratrol (3,5,4'-trihydroxystilbene) which is a polyphenol compound that is commonly found in grapes, is a nutritional supplement with anti-oxidant and anti-inflammatory properties with great promise for treating TBI secondary injury. A number of researchers have demonstrated that resveratrol protect multiple organs (heart, kidney, brain) from ischemia after injury. With respect to the brain, resveratrol has been shown to protect from oxidative stress, Huntington's disease, and stroke. Additionally, following TBI in various animal models, resveratrol protected from severe brain injuries. Results from these brain studies suggest that resveratrol protects from a plethora of injuries and may afford protection from secondary injury in individuals suffering from a severe brain injury.
In this pilot clinical trial, boxers (n=30) will be consented to participate in this study prior to engaging in a boxing match. The concussion history will be collected before enrolling. Baseline cognitive testing and magnetic resonance imaging (MRI) scan will be performed to obtain both structural and functional data. Only 12 boxers that have a concussion will be enrolled in this study. After participating in the boxing match, if the boxer has been diagnosed with having a concussion by the ringside physician, the boxers will be treated with an oral dose of the active trans-resveratrol (500 mg) or placebo within 2 hours of completion of the boxing match. The boxer will be treated with either resveratrol or placebo (depending on the randomization schedule) once a day for 30 days. Cognitive testing and MRI scans will be conducted on day 7 after the concussion.
- Conditions
- Sports Concussion
- Being tested
- Resveratrol, Placebo
- Keywords
- Mild Brain Injury, Concussions, Resveratrol, Boxers, ImPACT, MRI
- Medical subject headings
- Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDrug
The dose of resveratrol is 500 mg. The route of administration is oral, once-a-day for 30 days after injury.
PlaceboDrug
The placebo is a sugar pill. The route of administration is oral, once-a-day for 30 days after injury.
| Study group | Role | What they receive |
|---|---|---|
| Sugar Pill | Placebo comparator | Placebo control Receives: Drug: Placebo |
| Resveratrol | Experimental | Intervention Receives: Drug: Resveratrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Function Testing (Aspartate Transaminase [AST]/Alanine Transaminase [ALT] Ratios) to Screen for Adverse Events.
Liver Function Tests will be conducted on day 7 after concussion.
Measured: Day 7 post concussion
Liver Function Testing (Aspartate Transaminase [AST]/Alanine Transaminase [ALT] Ratios) to Screen for Adverse Events.
Liver Function Tests will be conducted on day 30 after concussion.
Measured: 30 Days post concussion
Secondary outcomes (4)
Functional Connectivity in Concussed Boxers
Functional connectivity magnetic resonance imaging
Measured: 30 Days
Reaction Time Composite as Assessed by Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Cognitive Test Performance
The reaction time composite score (range 0.5-0.8) is an average of: modules 3,4, 5, then divided by 3.The higher the composite score, the worse the outcomes.
- Average correct reaction time of interference stage of module 3 (X's and O'S) - Measures the number of correctly identified items (total possible correct =12), scoring 0-12. There is 4 trials of this module completed. Measures the average reaction time for correct responses on the interference (distracter) test
- Average correct reaction time of module 4 (Symbol Match) - Provides the number of correct matches out of 27 when the symbol number pairings are visible. The quicker the response time for each correctly identified symbol match indicates a better outcome.
- Average correct reaction time of module 5 (Color Match) - is number of correct color matches. The quicker the response time to a correct color match is a better outcome.
Each modules is measured in percentage correct
Measured: 7 days post concussion
Reaction Time Composite as Assessed by Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Cognitive Test Performance
The reaction time composite score (range 0.5-0.8) is an average of: modules 3,4, 5, then divided by 3.The higher the composite score, the worse the outcomes.
- Average correct reaction time of interference stage of module 3 (X's and O'S) - Measures the number of correctly identified items (total possible correct =12), scoring 0-12. There is 4 trials of this module completed. Measures the average reaction time for correct responses on the interference (distracter) test
- Average correct reaction time of module 4 (Symbol Match) - Provides the number of correct matches out of 27 when the symbol number pairings are visible. The quicker the response time for each correctly identified symbol match indicates a better outcome.
- Average correct reaction time of module 5 (Color Match) - is number of correct color matches. The quicker the response time to a correct color match is a better outcome.
Each modules is measured in percentage correct
Measured: 24-72 hours post concussion
Reaction Time Composite as Assessed by Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Cognitive Test Performance
The reaction time composite score (range 0.5-0.8) is an average of: modules 3,4, 5, then divided by 3.The higher the composite score, the worse the outcomes.
- Average correct reaction time of interference stage of module 3 (X's and O'S) - Measures the number of correctly identified items (total possible correct =12), scoring 0-12. There is 4 trials of this module completed. Measures the average reaction time for correct responses on the interference (distracter) test
- Average correct reaction time of module 4 (Symbol Match) - Provides the number of correct matches out of 27 when the symbol number pairings are visible. The quicker the response time for each correctly identified symbol match indicates a better outcome.
- Average correct reaction time of module 5 (Color Match) - is number of correct color matches. The quicker the response time to a correct color match is a better outcome.
Each modules is measured in percentage correct
Measured: 30 days post concussion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sports ConcussionStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Gatson, University of Texas Southwestern Medical Center
- Investigators
- Joshua W. Gatson, Ph.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321151
- Sponsor's protocol ID
- STU 092010-188
- Acronym
- REPAIR
- Status last verified
- Jan 2021
- First submitted
- 21 Mar 2011
- Last updated
- 11 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Resveratrol to Decrease Secondary Brain Injury Following Sports-Related Concussions: a Double-Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT01321151
- Acronym / sponsor ID
- REPAIR / STU 092010-188
- Conditions
- Sports Concussion
- Keywords
- Mild Brain Injury, Concussions, Resveratrol, Boxers, ImPACT, MRI
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 23 Mar 2011 (estimated)
- Results
- Posted 11 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sports-related concussions are a serious problem in football, boxing, and other full contact sports. After experiencing consecutive concussions, there is an increase in neurological deficits that can lead to long-term cognitive problems (Dementia pugilistica). To combat this increase in brain damage, novel strategies need to be developed to protect athletes that are participating in these full contact sports. The purpose of this study is to elucidate whether resveratrol decreases brain injury and improves brain function after experiencing a concussion in boxers.
Detailed description
Each year, approximately 3 million sports-related concussions occur in athletes. Only about 5% of these concussions are treated in the hospital setting. To date, there are no effective interventions used at decreasing the levels of oxidant injury and inflammation within these athletes. The standard form of care in these athletes is usually rest and light exercise for 1 -2 weeks, before returning to the sport. Within this brain injury population, administration of a neuro-protectant agent immediately following the concussion may alleviate or prevent secondary injury and subsequent development of long-term cognitive deficits such as Chronic Traumatic Encephalopathy (CTE) and Dementia pugilistica (DP). Since sports-related concussions are a serious problem in our youth, by using safe interventions, we believe that the levels of oxidant injury and brain inflammation will be decreased. In addition, these neuro-protective agents may improve cognition in these boxers, and decrease the incidence of DP.
Following brain injury, the secondary injury that immediately follows consists of heightened damage by oxygen radicals, which in turn damages vital lipids, proteins, and nucleic acids. This damage is exacerbated by highly acidic conditions with lead to the release of iron and the production of more harmful oxygen radicals. An increase in these oxygen radicals has been observed from minutes to hours within the primary injury. In addition, there is an increase in inflammation as well as excitotoxicity in the brain after traumatic injury. To combat this secondary injury, the use of anti-oxidants in individuals is warranted to decrease the amount of brain damage and cognitive decline after experiencing a severe brain injury. For example, resveratrol (3,5,4'-trihydroxystilbene) which is a polyphenol compound that is commonly found in grapes, is a nutritional supplement with anti-oxidant and anti-inflammatory properties with great promise for treating TBI secondary injury. A number of researchers have demonstrated that resveratrol protect multiple organs (heart, kidney, brain) from ischemia after injury. With respect to the brain, resveratrol has been shown to protect from oxidative stress, Huntington's disease, and stroke. Additionally, following TBI in various animal models, resveratrol protected from severe brain injuries. Results from these brain studies suggest that resveratrol protects from a plethora of injuries and may afford protection from secondary injury in individuals suffering from a severe brain injury.
In this pilot clinical trial, boxers (n=30) will be consented to participate in this study prior to engaging in a boxing match. The concussion history will be collected before enrolling. Baseline cognitive testing and magnetic resonance imaging (MRI) scan will be performed to obtain both structural and functional data. Only 12 boxers that have a concussion will be enrolled in this study. After participating in the boxing match, if the boxer has been diagnosed with having a concussion by the ringside physician, the boxers will be treated with an oral dose of the active trans-resveratrol (500 mg) or placebo within 2 hours of completion of the boxing match. The boxer will be treated with either resveratrol or placebo (depending on the randomization schedule) once a day for 30 days. Cognitive testing and MRI scans will be conducted on day 7 after the concussion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar Pill | Placebo comparator | Drug: PlaceboPlacebo control |
| Resveratrol | Experimental | Drug: ResveratrolIntervention |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Boxers between the ages 18-35 years old
- Both men and women
- Boxers with an estimated concussion (Mild and Moderate) as estimated by the on-site physician or athletic trainer
- Subject has provided full written informed consent prior to the performance of any protocol-specified procedure
Key exclusion criteria (6 listed)
- Immediate hospitalization for sports-related concussion (Severe Concussion)
- Known inclusion in an interventional clinical trial
- Patients with metal implants that would interfere with the MRI scan
- Known anemia
- Known Pregnancy
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 |
|---|---|---|
| ResveratrolThe dose of resveratrol is 500 mg. The route of administration is oral, once-a-day for 30 days after injury. | Drug | Resveratrol |
| PlaceboThe placebo is a sugar pill. The route of administration is oral, once-a-day for 30 days after injury. | Drug | Sugar Pill |
Primary outcome
Liver Function Testing (Aspartate Transaminase [AST]/Alanine Transaminase [ALT] Ratios) to Screen for Adverse Events.
Time frame: Day 7 post concussion
Liver Function Tests will be conducted on day 7 after concussion.
Liver Function Testing (Aspartate Transaminase [AST]/Alanine Transaminase [ALT] Ratios) to Screen for Adverse Events.
Time frame: 30 Days post concussion
Liver Function Tests will be conducted on day 30 after concussion.
4 secondary outcomes
Functional Connectivity in Concussed Boxers
Time frame: 30 Days
Reaction Time Composite as Assessed by Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Cognitive Test Performance
Time frame: 7 days post concussion
Reaction Time Composite as Assessed by Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Cognitive Test Performance
Time frame: 24-72 hours post concussion
Reaction Time Composite as Assessed by Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Cognitive Test Performance
Time frame: 30 days post concussion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joshua W. Gatson, Ph.D. principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Resveratrol in people with Sports Concussion, run by University of Texas Southwestern Medical Center 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 4 inclusion and 6 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 11 Feb 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Liver Function Testing (Aspartate Transaminase [AST]/Alanine Transaminase [ALT] Ratios) to Screen for Adverse Events. (time frame: Day 7 post concussion). The study lists 2 primary outcomes in all. 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 11 Feb 2021.