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Clinical Trials/NCT06052553
NCT06052553
Recruiting
Not Applicable

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

Mayo Clinic1 site in 1 country60 target enrollmentSeptember 9, 2023
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Mayo Clinic
Enrollment
60
Locations
1
Primary Endpoint
Change in peak force
Status
Recruiting
Last Updated
6 months ago

Overview

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

The neck plays a very important role in head positioning, stabilization, and decrease risk and severity. Neck extension strength measure has been associated with a decrease in concussion risk in male rugby players. Neck muscle characteristics may play a vital role in mitigating head accelerations due to contact thus reducing head impact severity. We hypothesize enhanced neuromuscular characteristics of cervical muscles will decrease brain impairments due to repeated contact.

Registry
clinicaltrials.gov
Start Date
September 9, 2023
End Date
April 1, 2026
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mario Hevesi

Principal Investigator

Mayo Clinic

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.

Outcomes

Primary Outcomes

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 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 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 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.

Secondary Outcomes

  • Change in King-Devick Test (KDT) scores(Baseline, post-season (approximately 6 months))

Study Sites (1)

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