A Study of TopSpin360 Training Device

• ClinicalTrials.gov Identifier: NCT06052553
• Recruitment Status: Recruiting
• First Posted: September 25, 2023
• Last Update Posted: April 9, 2024
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Michael J. Stuart MD, Mayo Clinic

Tracking Information

• First Submitted Date: September 18, 2023
• First Posted Date: September 25, 2023
• Last Update Posted Date: April 9, 2024
• Actual Study Start Date: September 9, 2023
• Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 19, 2023)

• Change in peak force [ Time Frame: Baseline, 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 force [ Time Frame: Baseline, post-season (approximately 6 months) ]
  Measured by a neck isometric device, peak force divided by participant weight in kilograms.
• Change in force steadiness [ Time Frame: Baseline, post-season (approximately 6 months) ]
  Measured by a neck isometric device, average peak force.
• Change in rate of force development (RFD) [ Time Frame: 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 time [ Time Frame: Baseline, post-season (approximately 6 months) ]
  Measured by a neck isometric device, reported in milliseconds (ms)
• Change in blood biomarker levels [ Time Frame: Baseline, 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 biomarkers [ Time Frame: Baseline, 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 Amplitude [ Time Frame: Baseline, 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 Latency [ Time Frame: Baseline, 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 Amplitude [ Time Frame: Baseline, 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 Latency [ Time Frame: Baseline, 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 Amplitude [ Time Frame: Baseline, 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 Latency [ Time Frame: Baseline, 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.

Original Primary Outcome Measures (submitted: September 22, 2023)

• Change in peak force [ Time Frame: Baseline, 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 force [ Time Frame: Baseline, post-season (approximately 6 months) ]
  Measured by a neck isometric device, peak force divided by participant weight in kilograms.
• Change in force steadiness [ Time Frame: Baseline, post-season (approximately 6 months) ]
  Measured by a neck isometric device, average peak force.
• Change in rate of force development (RFD) [ Time Frame: 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 time [ Time Frame: Baseline, post-season (approximately 6 months) ]
  Measured by a neck isometric device, reported in milliseconds (ms)
• Change in blood biomarker levels [ Time Frame: Baseline, post-season (approximately 6 months) ]
  Blood will be at a biomarker level. We will investigate 5 different markers: NfL, SNCB, vWF, SNCA, and BDNF.
• Change in salivary biomarkers [ Time Frame: Baseline, post-season (approximately 6 months) ]
  Salivary biomarkers are relatively new and we will investigate to see if NfL, SNCB, vWF, SNCA, and BDNF.
• Change in N100 Amplitude [ Time Frame: Baseline, 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 Latency [ Time Frame: Baseline, 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 Amplitude [ Time Frame: Baseline, 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 Latency [ Time Frame: Baseline, 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 Amplitude [ Time Frame: Baseline, 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 Latency [ Time Frame: Baseline, 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.

Current Secondary Outcome Measures (submitted: September 22, 2023)

Change in King-Devick Test (KDT) scores [ Time Frame: Baseline, 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of TopSpin360 Training Device
• Official Title: The Effectiveness of a Novel Neck Training Device on Objective Neck Strength and Cognitive Measures in Junior A Hockey Players
• 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: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Healthy

Intervention

Device: TopSpin360

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

Study 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.
  Intervention: Device: TopSpin360

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 22, 2023): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2025
• Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 21 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06052553
• Other Study ID Numbers: 23-005197
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Michael J. Stuart MD, Mayo Clinic
• Original Responsible Party: Michael J. Stuart, Mayo Clinic, Principal Investigator
• Current Study Sponsor: Mayo Clinic
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Michael Stuart, MD; Mayo Clinic

• PRS Account: Mayo Clinic
• Verification Date: April 2024