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

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

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Device: TopSpin360

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Houston Hawkins; Phone Number: 507-293-3295; Email: hawkins.houston@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Houston Hawkins; Phone Number: 507-293-3295; Email: hawkins.houston@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: TopSpin360; Helmet training device used to train head to stay stable during jarring impacts through dynamic and multi-planar neck strengthening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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)
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in King-Devick Test (KDT) scores	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.	Baseline, post-season (approximately 6 months)

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Michael Stuart, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 6, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Ice Hockey
• Other Study ID Numbers: 23-005197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No