NCT05122728 · Walter Reed National Military Medical Center
Post-Concussion Musculoskeletal Injury Risks
What this study is about
Musculoskeletal injuries (MSKI) and traumatic brain injury (TBI) are the signature injuries of the ongoing military conflicts. MSKI affect 800,000 Service Members annually and TBI have impacted more than 350,000 in the past 19 years and account for 22% of all combat casualties. Concussion, a mild form of TBI, increases MSKI risk in physically active individuals, including Service Members.
View original scientific description
Musculoskeletal injuries (MSKI) and traumatic brain injury (TBI) are the signature injuries of the ongoing military conflicts. MSKI affect 800,000 Service Members annually and TBI have impacted more than 350,000 in the past 19 years and account for 22% of all combat casualties. Concussion, a mild form of TBI, increases MSKI risk in physically active individuals, including Service Members. The overall goal of the study is to identify the neuromuscular control mechanisms that increase MSKI risk following concussion. It is hypothesized that concussed individuals will display abnormal neuromuscular function that increases MSKI risk, as compared to non-concussed controls. The study will employ a multi-center, prospective, case-matched control observational study to identify the differences in neuromuscular function following concussion that may contribute to increased MSKI risk. Once the neuromuscular control mechanisms that increase MSKI risk following concussion are identified, targeted risk mitigation strategies can be developed to reduce MSKI risk.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Concussed Cohort
- 18-40 years old.
- Self-reported asymptomatic post-concussion following enrollment into the study and monitoring of symptoms by research personnel via daily self-reported symptom questionnaires.
- Recruited within 5 days following being diagnosed with a concussion, and at least 72 hours prior to self-reporting as asymptomatic.
- Access to a functional email address and the internet for completion of patient reported outcomes (PROs) and musculoskeletal injury measures. Non-Concussed Cohort
- 18-40 years old.
- Active duty Service members and physically active civilians.
- No self-report history of concussion within the previous 5 years.
- No lingering post-concussion signs/symptoms.
- Same gender as the matched concussed participant.
- Within ±5% of the matched concussed participant's height, weight, and body mass index.
- Within ±2 years of age of the matched concussed participant.
- Participant in the same physical activities (work, recreational sports, average type \[no impact, low-impact, high-impact\] and duration of physical activity)
Exclusion criteria
- Post-Concussion Cohort AND Healthy Non-Concussed Cohort
- Unable to read or comprehend the English language.
- Admitted to the hospital following concussion.
- Sustained a concussion not related to physical activity participation (e.g., blast-related injury, fall from a ladder, motor vehicle accident).
- Loss of consciousness longer than 30 minutes.
- Alteration in consciousness longer than 24 hours.
- Post-traumatic amnesia lasting longer than 1 day.
- Glasgow Coma Scale below 13.
- Abnormal brain imaging findings.
- Sustained a concussion that took longer than 21 days for the individual to report as asymptomatic.
- A MSKI within the last 6 months that resulted in altered or missed physical activity for 3 or more consecutive days.
- History of MSKI surgery.
- Pregnant females (will be eligible for participation in the study once medically cleared to RTD/A by a qualified and licensed healthcare provider following the end of the pregnancy).
- Participants will be excluded if they present any known contraindications for electrical stimulation. These contraindications include conditions such as: active deep vein thrombosis/thrombophlebitis, any acute injury with concurrent inflammation, hemorrhagic conditions, impaired circulation, impaired local sensations, presence of infection (osteomyelitis, tuberculosis), malignancy, recently radiated tissue, skin disease/damage and/or at-risk skin.
- Present with any implanted pacemaker, electronic device, or plastic/cement material
Where
- Athens, Georgia
- Bethesda, Maryland
- Fort Bragg, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 27, 2026 · Source of record for eligibility and locations