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A Study of TopSpin360 Training Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06052553
Recruitment Status : Recruiting
First Posted : September 25, 2023
Last Update Posted : April 9, 2024
Sponsor:
Information provided by (Responsible Party):
Michael J. Stuart MD, Mayo Clinic

Study Description
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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

Condition or disease Intervention/treatment Phase
Healthy Device: TopSpin360 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effectiveness of a Novel Neck Training Device on Objective Neck Strength and Cognitive Measures in Junior A Hockey Players
Actual Study Start Date : September 9, 2023
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Change in force steadiness [ Time Frame: Baseline, post-season (approximately 6 months) ]
    Measured by a neck isometric device, average peak force.

  4. 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.

  5. Change in visuo-motor reaction time [ Time Frame: Baseline, post-season (approximately 6 months) ]
    Measured by a neck isometric device, reported in milliseconds (ms)

  6. 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).

  7. 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).

  8. 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.

  9. 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.

  10. 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.

  11. 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

  12. 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.

  13. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 21 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06052553


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

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Houston Hawkins    507-293-3295    hawkins.houston@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Michael Stuart, MD Mayo Clinic
More Information
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Responsible Party: Michael J. Stuart MD, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT06052553    
Other Study ID Numbers: 23-005197
First Posted: September 25, 2023    Key Record Dates
Last Update Posted: April 9, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Michael J. Stuart MD, Mayo Clinic:
Ice Hockey