A Study of TopSpin360 Training Device

NCT06052553 | Recruiting FDA Device

• 1 other identifier: 23-005197
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Ice Hockey

Outcome Measures

Primary Outcomes (13)

• Change in peak force

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

  Baseline, post-season (approximately 6 months)

• Change in normalized peak force

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

  Baseline, post-season (approximately 6 months)

• Change in force steadiness

  Measured by a neck isometric device, average peak force.

  Baseline, post-season (approximately 6 months)

• Change in rate of force development (RFD)

  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.

  Baseline, post-season (approximately 6 months)

• Change in visuo-motor reaction time

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

  Baseline, post-season (approximately 6 months)

• Change in blood biomarker levels

  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).

  Baseline, post-season (approximately 6 months)

• Change in salivary biomarkers

  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).

  Baseline, post-season (approximately 6 months)

• Change in N100 Amplitude

  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.

  Baseline, post-season (approximately 6 months)

• Change in N100 Latency

  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.

  Baseline, post-season (approximately 6 months)

• Change in P300 Amplitude

  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.

  Baseline, post-season (approximately 6 months)

• Change in P300 Latency

  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

  Baseline, post-season (approximately 6 months)

• Change in N400 Amplitude

  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.

  Baseline, post-season (approximately 6 months)

• Change in N400 Latency

  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.

  Baseline, post-season (approximately 6 months)

Secondary Outcomes (1)

• Change in King-Devick Test (KDT) scores

  Baseline, post-season (approximately 6 months)

Study Arms (2)

Control Group

NO INTERVENTION

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

TopSpin360 Intervention Group

EXPERIMENTAL

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

Device: TopSpin360

Interventions

TopSpin360 DEVICE

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

TopSpin360 Intervention Group

Eligibility Criteria

• Age: 18 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Study Officials

• Mario Hevesi, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Houston Hawkins

CONTACT

507-293-3295; Hawkins.Houston@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: September 9, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)