Cervical Spine Musculature for Concussion

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better ways to diagnose concussions and prevent future sports injuries by focusing on neck muscle control and vision training. Researchers believe that improving understanding of brain function can lead to better concussion diagnoses and lower the risk of injuries. The treatment being tested involves exercises for the cervical spine musculature (neck muscles). The trial seeks athletes aged 12 to 30 who regularly play sports and have no neck injuries or conditions that limit neck movement.

As an unphased trial, this study offers athletes a unique opportunity to contribute to groundbreaking research that could enhance sports safety and injury prevention.

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 prior data suggests that this protocol is safe for cervical spine musculature?

Research shows that strengthening neck muscles can reduce the risk of concussions in sports. Studies have found that increasing neck strength by just one pound can lower concussion risk by 5%. Exercising neck muscles is not only safe but also effective in preventing injuries. Reports indicate no serious side effects from strengthening neck muscles, making this method well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard concussion treatments that primarily focus on managing symptoms like headaches and dizziness with medication and rest, focusing on the cervical spine musculature offers a unique approach. Researchers are excited about this treatment because it targets the cervical spine muscles, which might play a role in stabilizing the head and neck post-injury, potentially reducing concussion symptoms. This novel approach could complement existing treatments by addressing the physical aspects of concussion recovery, offering a more holistic recovery path.

What evidence suggests that cervical spine musculature is effective for concussion?

Research shows that strengthening neck muscles can help reduce sports-related concussions. Studies have found that athletes with stronger necks experience fewer concussions. One study noted that increased neck strength led to less head movement and lower impact during sports. Another study reported a significant increase in neck strength among athletes over 12 weeks. Overall, stronger neck muscles seem to protect against concussions by stabilizing the head during impact. Participants in this trial will focus on strengthening the cervical spine musculature to evaluate its effectiveness in preventing concussions. ^{2 3 6 7 8}

Who Is on the Research Team?

David Soma, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1360859225003249

Does strengthening the cervical spine musculature ...

Two studies answered the primary objective that strengthening the cervical spine musculature reduces the incidence of sports-related concussions ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39229396/

Concussion Reduction in Division I and II Athletes

Results: All athletic teams experienced a significant increase in cervical strength during the 12-week intervention (α = 0.05, p < 0.05).

3.

jospt.org

jospt.org/doi/10.2519/jospt.2019.8582

The Potential Role of the Cervical Spine in Sports-Related ...

A stronger neck can decrease head acceleration, and is associated with reduced head velocity, peak acceleration, and displacement during impact ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6449018/

CHARACTERIZATION OF CERVICAL SPINE IMPAIRMENTS ...

This study provides preliminary data to support the framework for a cervical spine evaluation tool in children and adolescents following concussion.

5.

jospt.org

jospt.org/doi/10.2519/jospt.2023.11727

The Relationship Between Neck Strength and Sports ...

Five studies reported a relationship between greater neck strength or motor control and reduced concussion incidence. Pooled results from 4 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7102493/

The Potential Role of the Cervical Spine in Sports-Related ...

Neck strength, girth, and cervical spine posture have been identified as potential factors that reduce SRC risk by decreasing linear and rotational head ...

7.

cureus.com

cureus.com/articles/277314-concussion-reduction-in-division-i-and-ii-athletes-effects-of-simple-cervical-spine-exercise-regimen

Concussion Reduction in Division I and II Athletes: Effects ...

Research has indicated that every one-pound increase in neck strength corresponds to a 5% decrease in concussion risk [23]. A systematic review ...

8.

ncaa.org

ncaa.org/sports/2014/1/14/the-importance-of-training-the-head-and-neck.aspx

The Importance of Training the Head and Neck

Her results indicated that for every pound of improved neck strength, an individual reduces his or her concussion risk. Dr. Comstock from her ...