TopSpin360 Device for Neck Strength and Brain Function Improvement

Overseen By Houston Hawkins

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Hearing issues, Seizures, Implants, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 6 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called TopSpin360, designed to improve neck strength and brain function. It focuses on ice hockey players using the device twice a week during the hockey season. The trial includes two groups: one group will use the device, while the other will not engage in any special activities. The trial seeks ice hockey players who are fluent in English and medically cleared to play. As an unphased trial, participants can contribute to innovative research that may enhance athletic performance and safety.

Will I have to stop taking my current medications?

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

What prior data suggests that the TopSpin360 device is safe for neck strengthening and cognitive function improvement?

Research shows that the TopSpin360 device strengthens and stabilizes the neck, potentially lowering the risk of concussions. One study found the device effective in a 14-week neck strengthening program, with participants using it for short sessions of about 10-15 minutes, twice a week.

The device is primarily used for performance training. Although not officially approved as a medical treatment, it is recognized for enhancing sports safety. While specific data on side effects is lacking, the device is designed with safety and performance in mind and is generally well-tolerated by users.

Since this device isn't classified as a medical treatment, its safety relies more on its use in sports training rather than clinical trials. However, its acceptance in sports communities suggests it is generally safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TopSpin360 device because it offers a novel approach to improving neck strength and brain function, particularly for athletes. Unlike traditional exercises or physical therapy, this device uses dynamic rotational exercises to target the neck muscles more effectively. This unique mechanism might enhance stability and potentially reduce the risk of concussions, a feature that current standard care options do not directly address. Additionally, the ease of use and integration into regular sports routines make it a promising tool for ongoing athlete wellness.

What evidence suggests that the TopSpin360 device is effective for improving neck strength and cognitive function?

In this trial, participants in the TopSpin360 Intervention Group will use the TopSpin360 device. Research shows that this device strengthens neck muscles in all directions. Studies suggest that stronger neck muscles can reduce the risk of head injuries, benefiting athletes. Early results indicate that using TopSpin360 might enhance brain function, though more data is needed. By targeting specific neck muscles, the device aims to provide both physical and mental benefits. Overall, evidence supports its potential to strengthen neck muscles and possibly improve brain health. ^{1 2 6 7 8}

Who Is on the Research Team?

Mario Hevesi, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for healthy individuals who are medically cleared to play ice hockey and can speak English fluently. It's not suitable for those with pacemakers, hearing issues, skull implants, seizure history, or allergies to rubbing alcohol or EEG gel.

Inclusion Criteria

Medically cleared to play ice hockey

Fluent English Speaker

Exclusion Criteria

You are allergic to rubbing alcohol or the gel used for EEG testing.

Implanted pacemaker or defibrillator

I am not fluent in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the TopSpin360 device twice-weekly for the duration of the hockey season

Approximately 6 months

Follow-up

Participants are monitored for changes in biomarkers and cognitive measures post-season

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TopSpin360

Trial Overview The study is examining the TopSpin360 training device to see if it improves neck strength and cognitive function in participants who are active ice hockey players.

How Is the Trial Designed?

Group I: TopSpin360 Intervention Group Experimental Treatment 1 Intervention

Subjects will use TopSpin360, twice- weekly and use for the duration of the hockey season.

Group II: Control Group Active Control 1 Intervention

Subjects will receive no intervention for the duration of the hockey season.

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 involving 20 healthy participants, a fully immersive virtual reality game (VRPhysio) successfully prompted neck movements that were identified by physiotherapists as appropriate rehabilitation exercises.

No adverse events were reported during the session, suggesting that VR gamification could be a safe and effective method for encouraging adherence to neck rehabilitation exercises, warranting further evaluation in randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gamification of Cervical Spine Physiotherapy by Virtual Reality Software: Is This Real Rehabilitation? Gavish, L., Weissberger, O., Barzilay, Y.[2023]

A pilot study involving 18 participants (8 in the intervention group and 10 in the control group) demonstrated that a novel neuromuscular neck training device significantly improved dynamic and static neck strength after 7 weeks of training, with peak revolutions per minute (RPM) increasing from 122.8 to 252.3.

The intervention group showed a large positive effect in isometric neck strength, particularly in axial rotation, suggesting that this training could enhance neck muscle coordination and potentially reduce the risk of injuries like concussions and whiplash.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Effects of a Novel Neuromuscular Neck Training Device on Multiplanar Static and Dynamic Neck Strength: A Pilot Study. Versteegh, TH., Dickey, JP., Emery, CA., et al.[2021]

The CROM device demonstrated the highest reliability for measuring cervical range of motion in patients with neck pain, showing excellent reliability overall except for moderate reliability in right rotation.

iPhone applications for measuring cervical range of motion provided good to excellent reliability, making them a viable option for clinical use, while Android applications showed inconsistent reliability and are not recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone Applications as a Suitable Alternative to CROM Device and Inclinometers in Assessing the Cervical Range of Motion in Patients With Nonspecific Neck Pain. Ghorbani, F., Kamyab, M., Azadinia, F.[2022]

The Patient-Specific Functional Scale demonstrated excellent reliability (R = .92) and validity (correlation coefficients ranging from r = .73 to .83) when assessing disability in 31 patients with neck dysfunction, indicating it is a trustworthy tool for measuring patient outcomes.

The scale was sensitive to changes in disability over time, showing strong correlations with other established measures, and was equally effective as the Neck Disability Index in detecting changes, supporting its use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The patient-specific functional scale: validation of its use in persons with neck dysfunction. Westaway, MD., Stratford, PW., Binkley, JM.[2022]

The new test for detecting neck movement accuracy showed better reliability in asymptomatic individuals compared to those with chronic whiplash-associated disorders (WAD), indicating it may be more effective for assessing healthy neck function.

The test successfully discriminated between the two groups, revealing that individuals with chronic WAD had poorer performance in neck movement accuracy, which could help in evaluating and treating neck pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new clinical test for cervicocephalic kinesthetic sensibility: "the fly". Kristjansson, E., Hardardottir, L., Asmundardottir, M., et al.[2019]

In a study involving 152 participants with neck pain, combining local neck treatment with joint position sense (JPS) and balance exercises led to the most significant improvements in proprioception and balance, with medium to large effect sizes observed.

All treatment combinations resulted in both short- and long-term benefits for neck pain, dizziness, and related symptoms, but the addition of sensorimotor training helped maintain these improvements over 6 to 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of adding rehabilitation of cervical related sensorimotor control to manual therapy and exercise for neck pain: A randomized controlled trial. Sremakaew, M., Jull, G., Treleaven, J., et al.[2023]

The NSE-1 neck training machine effectively increased neck strength in air force pilots, with improvements of up to 83.7% in various neck movements after 6 weeks of training.

The training was conducted safely and effectively, utilizing advanced technologies like adaptive hydraulics and biological feedback to optimize resistance and velocity during exercises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Research, design and application of model NSE-1 neck muscle training machine for pilots]. Cheng, H., Wang, Z., Liu, S., et al.[2011]

In a study of 55 participants with chronic neck pain, McKenzie exercises combined with traditional physical therapy led to significantly greater improvements in pain severity, cervical mobility, and functional disability compared to deep neck flexor (DNF) exercises combined with scapulothoracic exercises.

Both exercise interventions resulted in reduced neck pain and increased range of motion, but the McKenzie group showed superior outcomes over the DNF group and the control group after 6 weeks of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of McKenzie protocol vs. deep neck flexor and scapulothoracic exercises in subjects with chronic neck pain - a randomized controlled study. Abdel-Aziem, AA., Mohamed, RR., Draz, AH., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06052553

NCT06052553 | A Study of TopSpin360 Training Device This research is being done to investigate the novel neck strengthening device, TopSpin360 and its effectiveness on measures of neck strength and cognitive ...

2. topspin360.com topspin360.com/research/

Research on TopSpin360 - TopSpin Technologies Discover how TopSpin360 enhances neck strength. Explore the research findings that highlight its effectiveness across all three planes of neck motion.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11624327/

Evaluating a 14-week neck strengthening protocol for ... Increased neck strength has been linked to a potential decrease in traumatic brain injuries (TBI). The purpose was to determine the efficacy of a ...

4. sportsmith.co sportsmith.co/articles/neck-training-to-improve-performance-and-injury-outcomes/

Neck training to improve performance and injury outcomes Athletes with weakened neck muscles who are experiencing neck pain exhibit deficits in strength related outcomes including strength-endurance, ...

5. mayo.edu mayo.edu/research/clinical-trials/cls-20555396

Effectiveness of TOPSPIN360 on Measures of Neck ... The purpose of this study is to investigate the effectiveness of a novel training device (TopSpin360) on measures of neck strength as well as cognitive in ...

6. topspin360.com topspin360.com/?page_id=3901

Research on TopSpin360 - TopSpin Technologies TopSpin360 was developed as a performance training tool to improve neck strength and dynamic stability. It is not a medical device and is not intended to ...

7. x.com x.com/topspin360

TopSpin360 - Dynamic Neck Strength A device for mitigating the risk of concussions through dynamic strength training of the neck. Winner of the NFL 1st & Future competition.

8. topspin360.com topspin360.com/how-it-works/

How the TopSpin360 Works Learn how the TopSpin360 enhances neck strength and plays a vital role in the prevention of head injury, promoting safer practices in sports and fitness.