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NCT Number: 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 function.

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Key information

Conditions

Age range

18 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Houston Hawkins

CONTACT

[email protected]

507-293-3295

About this study

The neck plays a very important role in head positioning, stabilization, and decrease risk and severity. Neck extension strength measure has been associated with a decrease in concussion risk in male rugby players. Neck muscle characteristics may play a vital role in mitigating head accelerations due to contact thus reducing head impact severity. We hypothesize enhanced neuromuscular characteristics of cervical muscles will decrease brain impairments due to repeated contact.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fluent English Speaker.
  • Medically cleared to play ice hockey.

Exclusion criteria

  • Clinically documented hearing issues.
  • In-ear hearing aid or cochlear implant.
  • Implanted pacemaker or defibrillator.
  • Metal or plastic implants in skull. lack of verbal fluency in the English language.
  • History of seizures.
  • Allergy to rubbing alcohol or EEG gel.

Treatment and study plan

TopSpin360

Device

Helmet training device used to train head to stay stable during jarring impacts through dynamic and multi-planar neck strengthening.

Primary outcomes

  1. Change in peak force

    Time frame: Baseline, post-season (approximately 6 months)

    Measured by a neck isometric device, maximal load in kilograms that could be applied to head before deviation from neutral position.

  2. Change in normalized peak force

    Time frame: Baseline, post-season (approximately 6 months)

    Measured by a neck isometric device, peak force divided by participant weight in kilograms.

  3. Change in force steadiness

    Time frame: Baseline, post-season (approximately 6 months)

    Measured by a neck isometric device, average peak force.

  4. Change in rate of force development (RFD)

    Time frame: Baseline, post-season (approximately 6 months)

    Automatically collected by the TopSpin360 device, the multi-planar rate of force development (RFD) in pounds of force per second collected in both clockwise and counterclockwise.

  5. Change in visuo-motor reaction time

    Time frame: Baseline, post-season (approximately 6 months)

    Measured by a neck isometric device, reported in milliseconds (ms)

  6. Change in blood biomarker levels

    Time frame: Baseline, post-season (approximately 6 months)

    Blood will be at a biomarker level. We will investigate 5 different markers: NfL, SNCB, vWF, SNCA, and BDNF. Each biomarker will be measured in Nanograms per Milliliter (ng/ml).

  7. Change in salivary biomarkers

    Time frame: Baseline, post-season (approximately 6 months)

    Salivary biomarkers are relatively new and we will investigate to see if NfL, SNCB, vWF, SNCA, and BDNF. Each biomarker will be measured in Nanometer per milliliter (ng/ml).

  8. Change in N100 Amplitude

    Time frame: Baseline, post-season (approximately 6 months)

    Electroencephalograph (EEG) recording of brain electrical activity N100 potential amplitude. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores.

  9. Change in N100 Latency

    Time frame: Baseline, post-season (approximately 6 months)

    Electroencephalograph (EEG) recording of brain electrical activity N100 potential latency. Increased latencies are indicative of slower responses. Obtained by EEG recording of N100 potential amplitude. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores.

  10. Change in P300 Amplitude

    Time frame: Baseline, post-season (approximately 6 months)

    Electroencephalograph (EEG) recording of brain electrical activity P300 potential amplitude. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores.

  11. Change in P300 Latency

    Time frame: Baseline, post-season (approximately 6 months)

    Electroencephalograph (EEG) recording of brain electrical activity P300 potential latency. Increased latencies are indicative of slower responses. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores

  12. Change in N400 Amplitude

    Time frame: Baseline, post-season (approximately 6 months)

    Electroencephalograph (EEG) recording of brain electrical activity N400 potential amplitude. Increased amplitudes are indicative of larger signals. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores.

  13. Change in N400 Latency

    Time frame: Baseline, post-season (approximately 6 months)

    Electroencephalograph (EEG) recording of brain electrical activity N400 potential latency. Increased latencies are indicative of slower responses. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores.

Secondary outcomes

  1. Change in King-Devick Test (KDT) scores

    Time frame: Baseline, post-season (approximately 6 months)

    A rapid number-naming test that requires individuals to read 3 numbered patters aloud as fast as possible, the resulting time if the KDT score. The post-season score is compared to the pre-season baseline. An increase in the number of seconds required to read the 3 number patterns is considered to be significant.

Study contacts

Contact information is provided by the study sponsor or research team.

Houston Hawkins

CONTACT

[email protected]

507-293-3295

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

The Effectiveness of a Novel Neck Training Device on Objective Neck Strength and Cognitive Measures in Junior A Hockey Players

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 25, 2023
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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