Clinical trial NCT06052553: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Ice Hockey
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 21
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Change in peak force
timeFrame: Baseline, post-season (approximately 6 months)
measure: Change in normalized peak force
timeFrame: Baseline, post-season (approximately 6 months)
measure: Change in force steadiness
timeFrame: Baseline, post-season (approximately 6 months)
measure: Change in rate of force development (RFD)
timeFrame: Baseline, post-season (approximately 6 months)
measure: Change in visuo-motor reaction time
timeFrame: Baseline, post-season (approximately 6 months)
measure: Change in blood biomarker levels
timeFrame: Baseline, post-season (approximately 6 months)
measure: Change in salivary biomarkers
timeFrame: Baseline, post-season (approximately 6 months)
measure: Change in N100 Amplitude
timeFrame: Baseline, post-season (approximately 6 months)
measure: Change in N100 Latency
timeFrame: Baseline, post-season (approximately 6 months)
measure: Change in P300 Amplitude
timeFrame: Baseline, post-season (approximately 6 months)
measure: Change in P300 Latency
timeFrame: Baseline, post-season (approximately 6 months)
measure: Change in N400 Amplitude
timeFrame: Baseline, post-season (approximately 6 months)
measure: Change in N400 Latency
timeFrame: Baseline, post-season (approximately 6 months)
Secondary outcomes:
measure: Change in King-Devick Test (KDT) scores
timeFrame: Baseline, post-season (approximately 6 months)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mario Hevesi, MD
role: PRINCIPAL_INVESTIGATOR
References: