A Study of TopSpin360 Training Device

NCT ID: NCT06052553

Last Updated: 2025-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-09

Study Completion Date

2026-04-30

Brief Summary

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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

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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

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Control Group

Subjects will receive no intervention for the duration of the hockey season.

Group Type NO_INTERVENTION

No interventions assigned to this group

TopSpin360 Intervention Group

Subjects will use TopSpin360, twice- weekly and use for the duration of the hockey season.

Group Type EXPERIMENTAL

TopSpin360

Intervention Type DEVICE

Helmet training device used to train head to stay stable during jarring impacts through dynamic and multi-planar neck strengthening.

Interventions

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TopSpin360

Helmet training device used to train head to stay stable during jarring impacts through dynamic and multi-planar neck strengthening.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mario Hevesi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mario Hevesi, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Houston Hawkins

Role: CONTACT

507-293-3295

Facility Contacts

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Houston Hawkins

Role: primary

507-293-3295

Other Identifiers

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23-005197

Identifier Type: -

Identifier Source: org_study_id

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