Cervical Spine Musculature for Concussion

Recruiting at 2 trial locations

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Neck conditions, Head lice, Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 months

4000 Participants Needed

Trial Summary

What is the purpose of this trial?

The overall objective is to provide an onsite diagnosis with subsequent return to play criteria, as well as, lower the risk of traumatic brain injury by primary prevention through cervical spine neuromuscular control and vision training. The central hypothesis is that improved understanding of neurocognitive measures and function will provide improved diagnosis of concussion and help reduce the incidence of subsequent sports-related injury.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of cervical spine musculature treatment for concussion?

Research suggests that improving cervical spine alignment and neck strength may help reduce concussion symptoms and the risk of future concussions, as seen in a case study of a rugby player. Additionally, understanding neck muscle characteristics can aid in developing targeted treatments for concussion-related issues. ^{1 2 3 4 5}

Is cervical spine musculature treatment generally safe for humans?

The research does not provide specific safety data for cervical spine musculature treatment, but it discusses its role in improving post-concussion symptoms and suggests that understanding neck muscle strength and morphology could lead to better treatment protocols. ^{1 2 3 4 5}

How does the treatment for cervical spine musculature differ from other concussion treatments?

This treatment focuses on strengthening the neck muscles to potentially reduce concussion risk, which is different from other treatments that may not address neck strength. It is unique because it targets the cervical spine (neck area) to improve head stability and reduce injury risk, rather than just treating symptoms after a concussion occurs. ^{1 2 3 4 5}

Research Team

David Soma, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for competitive or recreational athletes aged between 12 and 30 years old who are looking to get a quick diagnosis of concussion with criteria to return to play. It's not suitable for those who may be pregnant, have conditions affecting neck movement or strength, or have had recent head lice exposure.

Exclusion Criteria

Known or suspected pregnancy

I cannot move or test the strength of my neck due to a pre-existing condition.

Recent exposure to head lice

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cervical spine neuromuscular control and vision training to improve neurocognitive measures and reduce concussion risk

4 months

Follow-up

Participants are monitored for changes in blood metabolite profiles and neurocognitive function after the intervention

4 weeks

Treatment Details

Interventions

• Cervical spine musculature

Trial Overview The study aims to diagnose concussions on-site and prevent brain injuries by training the muscles in the cervical spine (neck) and improving vision-related reactions. The goal is better understanding of neurocognitive measures related to sports injuries.

Participant Groups

Group I: Cervical spine musculature Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

A 27-year-old professional rugby player with a history of 20 concussions showed significant improvement in post-concussion syndrome after 30 sessions of cervical rehabilitation, with lasting benefits observed over 6 years.

Post-treatment, the player's cervical spinal alignment improved significantly, and he experienced only two additional concussions in the following six years, suggesting that correcting cervical alignment may help reduce the risk of future concussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-concussion syndrome and concussion incidence improved in a pro rugby player following cervical spine rehab: case study and 6-year follow-up. Strauss, S., Lightstone, DF., Fedorchuk, C., et al.[2023]

In a study of 73 children and adolescents undergoing physical therapy after a concussion, 90% exhibited cervical impairments in at least three out of five assessment categories, highlighting the commonality of these issues post-injury.

The most frequently observed impairments were in posture (99%) and myofascial issues (98%), indicating that targeted physical therapy interventions should focus on these areas to effectively address cervical spine impairments following concussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CHARACTERIZATION OF CERVICAL SPINE IMPAIRMENTS IN CHILDREN AND ADOLESCENTS POST-CONCUSSION. Tiwari, D., Goldberg, A., Yorke, A., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Post-concussion syndrome and concussion incidence improved in a pro rugby player following cervical spine rehab: case study and 6-year follow-up. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Cervical Spine Dysfunction Following Pediatric Sports-Related Head Trauma. [2020]

3. Australia pubmed.ncbi.nlm.nih.gov

The role of cervical muscles in mitigating concussion. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Sex-related differences in sternocleidomastoid muscle morphology in healthy young adults: A cross-sectional magnetic resonance imaging measurement study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

CHARACTERIZATION OF CERVICAL SPINE IMPAIRMENTS IN CHILDREN AND ADOLESCENTS POST-CONCUSSION. [2022]