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A Study of TopSpin360 Training Device

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06052553
Enrollment
60
Registered
2023-09-25
Start date
2023-09-09
Completion date
2027-04-01
Last updated
2026-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Ice Hockey

Brief summary

This research is being done to investigate the novel neck strengthening device, TopSpin360 and its effectiveness on measures of neck strength and cognitive function.

Detailed description

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.

Interventions

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

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 21 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in peak forceBaseline, 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.
Change in normalized peak forceBaseline, post-season (approximately 6 months)Measured by a neck isometric device, peak force divided by participant weight in kilograms.
Change in force steadinessBaseline, post-season (approximately 6 months)Measured by a neck isometric device, average peak force.
Change in rate of force development (RFD)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.
Change in visuo-motor reaction timeBaseline, post-season (approximately 6 months)Measured by a neck isometric device, reported in milliseconds (ms)
Change in blood biomarker levelsBaseline, 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).
Change in salivary biomarkersBaseline, 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).
Change in N100 AmplitudeBaseline, 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.
Change in N100 LatencyBaseline, 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.
Change in P300 AmplitudeBaseline, 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.
Change in P300 LatencyBaseline, 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
Change in N400 AmplitudeBaseline, 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.
Change in N400 LatencyBaseline, 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

MeasureTime frameDescription
Change in King-Devick Test (KDT) scoresBaseline, 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.

Countries

United States

Contacts

CONTACTHouston Hawkins
Hawkins.Houston@mayo.edu507-293-3295
PRINCIPAL_INVESTIGATORMario Hevesi, MD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 23, 2026