Pro-2-Cool Pivotal Trial II

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
TecTraum Inc.
Study ID
NCT06929923
Status
Recruiting
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Conditions

  • Concussion, Mild

Eligibility Criteria

Sex
ALL
Age
13 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Pro2Cool Device — DEVICE
    The Pro2Cool Device is a non-invasive hypothermic therapy ("cold therapy") device that provides localized cooling of the head and neck. Water and isopropyl alcohol cooled to 6°C by the chiller assembly circulate through the cooling garment to create conductive heat transfer from the scalp and carotid arteries, thus achieving cooling of the brain.
  • Sham Cooling Garment Device — DEVICE
    The sham cooling garment device will be placed with impaired cooling function (only to the head), with sham treatment temperature being set to 19°C (instead of the therapeutic 6°C specification). There will be no thermal nylon barrier that will be used and flow to the neck bladder will be closed.

Study Details

This study is being conducted to determine the clinical safety and efficacy of Pro-2-Cool mediated head and neck cooling when applied after concussion and improved symptomatology among adolescent athletes as quantified by post-concussion symptom severity (PCSS) score.

Key Dates

Start date
Feb 20, 2025
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pro2Cool intervention with standard of care
    The treatment arm will receive standard of care for concussion along with 30 minutes of headneck cooling in the clinic while being monitored for side effects. The Pro2Cool® will be used to provide head and neck cooling.
  • Sham Comparator: Sham Pro2Cool with standard of care
    The control arm will receive standard of care like the treatment group, along with 30 minutes of sham Pro2Cool® placement in the clinic while being monitored for side effects. The Pro2Cool® device will not be used to provide neck cooling; a sham cooling garment device will be placed with impaired cooling function (only to the head), with sham treatment temperature being set to 19°C (instead of the therapeutic 6°C specification).

Primary Outcome Measure

Change quantified by post-concussion symptom severity (PCSS) assessment score [ Time Frame: Post-injury to 72-hour follow-up ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Ingrid Ichesco, MD (PRINCIPAL_INVESTIGATOR)
Akron Children's HospitalAkronOhio44308
Brian Reilly, MD (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic FoundationClevelandOhio44125
Sami Rifat, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Ann Arbor, MI

By research site
University of Michigan· Ann Arbor, MIAkron Children's Hospital· Akron, OHCleveland Clinic Foundation· Cleveland, OH

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