Use of Resveratrol to Decrease Acute Secondary Brain Injury Following Sports-Related Concussions in Boxers (REPAIR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joshua Gatson, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01321151
First received: March 21, 2011
Last updated: January 7, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Sports Concussion
Dietary Supplement: Resveratrol
Dietary Supplement: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Resveratrol to Decrease Secondary Brain Injury Following Sports-Related Concussions: a Double-Blind, Placebo-Controlled Study

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • To determine the number of adverse events that may be associated with the use of resveratrol in this population. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    To determine safety, Liver Function Tests will be conducted at day 7 and 30 in the boxers after experiencing a concussion to screen for asymptomatic adverse events.


Secondary Outcome Measures:
  • Cognitive Outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The ImPACT cognitive test performance of each subject will be compared to their baseline scores. We hypothesize that resveratrol will improve cognitive performance after injury.

  • Axonal Injury [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    We will determine the efficacy of resveratrol on decreasing axonal injury in the brain using magnetic resonance imaging (MRI) at day 7 after injury.


Enrollment: 12
Study Start Date: March 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar Pill
Placebo control
Dietary Supplement: Placebo
The placebo is a sugar pill. The route of administration is oral, once-a-day for 30 days after injury.
Experimental: Resveratrol
Intervention
Dietary Supplement: Resveratrol
The dose of resveratrol is 500 mg. The route of administration is oral, once-a-day for 30 days after injury.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Boxers between the ages 18-35 years old
  2. Both men and women
  3. Boxers with an estimated concussion (Mild and Moderate) as estimated by the on-site physician or athletic trainer
  4. Subject has provided full written informed consent prior to the performance of any protocol-specified procedure

Exclusion Criteria:

  1. Immediate hospitalization for sports-related concussion (Severe Concussion)
  2. Known inclusion in an interventional clinical trial
  3. Patients with metal implants that would interfere with the MRI scan
  4. Known anemia
  5. Known Pregnancy
  6. Known history of alcohol/drug abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01321151

Locations
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Joshua W. Gatson, Ph.D. University of Texas Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Joshua Gatson, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01321151     History of Changes
Other Study ID Numbers: 092010-188
Study First Received: March 21, 2011
Last Updated: January 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Texas Southwestern Medical Center:
Mild Brain Injury
Concussions
Resveratrol
Boxers
ImPACT
MRI

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Antimutagenic Agents
Anticarcinogenic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014