A Study of TopSpin360 Training Device

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06052553
• Other study ID #: 23-005197
• Status: Recruiting
• Phase: N/A
• Start date: September 9, 2023
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: Houston Hawkins
• Phone: 507-293-3295
• Email: Hawkins.Houston[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• TopSpin360
Helmet training device used to train head to stay stable during jarring impacts through dynamic and multi-planar neck strengthening.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	Change in force steadiness	Measured by a neck isometric device, average peak force.	Baseline, post-season (approximately 6 months)
Primary	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)
Primary	Change in visuo-motor reaction time	Measured by a neck isometric device, reported in milliseconds (ms)	Baseline, post-season (approximately 6 months)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)