HealthyNCT06052553
A Study of TopSpin360 Training Device
A study testing TopSpin360 in people with Healthy, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TopSpin360
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2023to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 21 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fluent English Speaker.
- Medically cleared to play ice hockey.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Houston Hawkins, 507-293-3295, hawkins.houston@mayo.edu
About this study
Official title: The Effectiveness of a Novel Neck Training Device on Objective Neck Strength and Cognitive Measures in Junior A Hockey Players
This research is being done to investigate the novel neck strengthening device, TopSpin360 and its effectiveness on measures of neck strength and cognitive function.
Read the 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.
- Conditions
- Healthy
- Being tested
- TopSpin360
- Keywords
- Ice Hockey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopSpin360Device
Helmet training device used to train head to stay stable during jarring impacts through dynamic and multi-planar neck strengthening.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Subjects will receive no intervention for the duration of the hockey season. |
| TopSpin360 Intervention Group | Experimental | Subjects will use TopSpin360, twice- weekly and use for the duration of the hockey season. Receives: Device: TopSpin360 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak force
Measured by a neck isometric device, maximal load in kilograms that could be applied to head before deviation from neutral position.
Measured: Baseline, post-season (approximately 6 months)
Change in normalized peak force
Measured by a neck isometric device, peak force divided by participant weight in kilograms.
Measured: Baseline, post-season (approximately 6 months)
Change in force steadiness
Measured by a neck isometric device, average peak force.
Measured: Baseline, post-season (approximately 6 months)
Change in rate of force development (RFD)
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.
Measured: Baseline, post-season (approximately 6 months)
Change in visuo-motor reaction time
Measured by a neck isometric device, reported in milliseconds (ms)
Measured: Baseline, post-season (approximately 6 months)
Change in blood biomarker levels
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).
Measured: Baseline, post-season (approximately 6 months)
Change in salivary biomarkers
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).
Measured: Baseline, post-season (approximately 6 months)
Change in N100 Amplitude
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.
Measured: Baseline, post-season (approximately 6 months)
Change in N100 Latency
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.
Measured: Baseline, post-season (approximately 6 months)
Change in P300 Amplitude
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.
Measured: Baseline, post-season (approximately 6 months)
Change in P300 Latency
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
Measured: Baseline, post-season (approximately 6 months)
Change in N400 Amplitude
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.
Measured: Baseline, post-season (approximately 6 months)
Change in N400 Latency
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.
Measured: Baseline, post-season (approximately 6 months)
Secondary outcomes (1)
Change in King-Devick Test (KDT) scores
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.
Measured: Baseline, post-season (approximately 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start9 Sep 2023
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Hevesi, Mayo Clinic
- Investigators
- Mario Hevesi, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052553
- Sponsor's protocol ID
- 23-005197
- Status last verified
- Jul 2026
- First submitted
- 18 Sep 2023
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Novel Neck Training Device on Objective Neck Strength and Cognitive Measures in Junior A Hockey Players
- ClinicalTrials.gov ID
- NCT06052553
- Acronym / sponsor ID
- 23-005197
- Conditions
- Healthy
- Keywords
- Ice Hockey
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 9 Sep 2023 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Subjects will receive no intervention for the duration of the hockey season. |
| TopSpin360 Intervention Group | Experimental | Device: TopSpin360Subjects will use TopSpin360, twice- weekly and use for the duration of the hockey season. |
Who may qualify
- Ages
- 18 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Fluent English Speaker.
- Medically cleared to play ice hockey.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TopSpin360Helmet training device used to train head to stay stable during jarring impacts through dynamic and multi-planar neck strengthening. | Device | TopSpin360 Intervention Group |
Primary outcome
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.
1 secondary outcome
Change in King-Devick Test (KDT) scores
Time frame: Baseline, post-season (approximately 6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mario Hevesi, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TopSpin360 in people with Healthy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Houston Hawkins (507-293-3295, Hawkins.Houston@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peak force (time frame: Baseline, post-season (approximately 6 months)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.