Recruiting

TopSpin360

Sponsor:

Mayo Clinic

Code:

NCT06052553

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 21

Healthy Volunteers: Accepted

Interventions

TopSpin360

Study Details

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.

Conditions

Healthy

Study ID

NCT06052553

Start date

Sep 9, 2023

Status verified date

Jul, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 21

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

no intervention: Control Group

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

experimental: TopSpin360 Intervention Group

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

Interventions

TopSpin360

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

Primary outcome measure

  • Change in peak force [ Time Frame: Baseline, post-season (approximately 6 months) ]
  • Change in normalized peak force [ Time Frame: Baseline, post-season (approximately 6 months) ]
  • Change in force steadiness [ Time Frame: Baseline, post-season (approximately 6 months) ]
  • Change in rate of force development (RFD) [ Time Frame: Baseline, post-season (approximately 6 months) ]
  • Change in visuo-motor reaction time [ Time Frame: Baseline, post-season (approximately 6 months) ]
  • Change in blood biomarker levels [ Time Frame: Baseline, post-season (approximately 6 months) ]
  • Change in salivary biomarkers [ Time Frame: Baseline, post-season (approximately 6 months) ]
  • Change in N100 Amplitude [ Time Frame: Baseline, post-season (approximately 6 months) ]
  • Change in N100 Latency [ Time Frame: Baseline, post-season (approximately 6 months) ]
  • Change in P300 Amplitude [ Time Frame: Baseline, post-season (approximately 6 months) ]
  • Change in P300 Latency [ Time Frame: Baseline, post-season (approximately 6 months) ]
  • Change in N400 Amplitude [ Time Frame: Baseline, post-season (approximately 6 months) ]
  • Change in N400 Latency [ Time Frame: Baseline, post-season (approximately 6 months) ]

Central Contacts and Locations

Central contacts

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

More Information

Sponsor

Mayo Clinic

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • Ice Hockey

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-07-22.