A Study of TopSpin360 Training Device
- Conditions
- Healthy
- Interventions
- Device: TopSpin360
- Registration Number
- NCT06052553
- Lead Sponsor
- Mayo Clinic
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Fluent English Speaker.
- Medically cleared to play ice hockey.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TopSpin360 Intervention Group TopSpin360 Subjects will use TopSpin360, twice- weekly and use for the duration of the hockey season.
- Primary Outcome Measures
Name Time Method Change in peak force 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 Baseline, post-season (approximately 6 months) Measured by a neck isometric device, peak force divided by participant weight in kilograms.
Change in force steadiness Baseline, post-season (approximately 6 months) Measured by a neck isometric device, average peak force.
Change in N100 Latency 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 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) 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 Baseline, post-season (approximately 6 months) Measured by a neck isometric device, reported in milliseconds (ms)
Change in blood biomarker levels 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 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 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 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 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 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
Name Time Method Change in King-Devick Test (KDT) scores 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.
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States