Concussion, MildNCT06929923
Pro-2-Cool Pivotal Trial II
A study testing Pro2Cool Device in people with Concussion, Mild, run by TecTraum Inc. at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 21 years
- Conditions the study is for
- Concussion, Mild
- What is being tested?
- Pro2Cool Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Feb 2025to Jun 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 13 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and females, 13-21 years of age
- Confirmed concussion diagnosis consistent with American Congress Rehabilitation Medicine guidelines 21, without any of the following:
- Glasgow Coma Scale (GCS) score of less than 13 at 30 minutes post-injury
- Loss of consciousness greater than 30 minutes
- Post-traumatic amnesia lasting over 24 hours
- Glasgow Coma Scale (GCS) ≥ 13 at the time of initial injury for study enrollment.
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- Post-Concussion Symptom Scale Score minimum of 15
- Initial provider visit is within 7 days of injury
- In generally good health as confirmed by medical history and determined by site investigator or designated trained healthcare professional under the supervision of the principal investigator.
- Has informed consent obtained per protocol and as required per Institutional Review Board
Who cannot join
- Age < 13 years or > 21 years
- Inability to understand the study requirements or provide informed consent
- Cleared to return to play during initial visit
- Prior participation in a Pro2Cool Clinical Study
- Serious traumatic brain injury as evidenced by worsening symptoms:
- Vomiting > 2 episodes following injury
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- Seizure
- Hospitalization
- Radiology scan indicating brain bleed
- Slurred speech which has not resolved within 72 hours of concussive injury
- Physical (e.g., head or neck injury that requires medical treatment) or mental disability hindering adequate response to assessment of symptoms
- Hemodynamic instability/medical condition requiring further acute life-saving medical intervention
- History of psychiatric disorder that includes suicide attempts within the last 6 months, unmanaged depression or anxiety, hospitalization for psychiatric treatment within the last 6 months
- Known brain mass, intracranial hemorrhage, skull fracture
- Scalp abnormalities including laceration or bleeding
- Presence of ventriculoperitoneal (VP) shunt
- Known hematological malignancies, including, but not limited to: multiple myeloma, leukemia, and lymphoma
- Known history of Reynaud's Disease compromised liver function, cold agglutination, cold sensitivity, cryoglobulinemia, cryofibrinogenemia, and/or a history of severe migraines
- Known or disclosed pregnancy or breast-feeding
- Sustains another head or neck injury at the time of concussive injury which requires medical treatment
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Rebecca Zickert contact
United States3 sites, 3 recruiting
- Recruiting
Akron Children's Hospital
Akron, Ohio, 44308
Brian Reilly, MD
- Not yet recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Ingrid Ichesco, MD
- Not yet recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44125
Sami Rifat, MD
About this study
Official title: A Double-Blind, Randomized Study of Clinical Efficacy of Hypothermic Therapy Following Concussion in Adolescent Athletes as Compared to a Sham-Controlled Population
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.
Read the detailed description
This is a multi-center, prospective, randomized, double-blinded, dual-arm comparative study enrolling up to a total of 66 patients (approximately 33 patients in the treatment arm and 33 patients in the control arm) following sports-related, concussion.
- Conditions
- Concussion, Mild
- Being tested
- Pro2Cool Device, Sham Cooling Garment Device
- Keywords
- Non-invasive hypothermic therapy, Sports-related concussion
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro2Cool DeviceDevice
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 DeviceDevice
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 group | Role | What they receive |
|---|---|---|
| Pro2Cool intervention with standard of care | Experimental | 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. Receives: Device: Pro2Cool Device |
| Sham Pro2Cool with standard of care | Sham comparator | 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). Receives: Device: Sham Cooling Garment Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change quantified by post-concussion symptom severity (PCSS) assessment score
Measured: Post-injury to 72-hour follow-up
Secondary outcomes (1)
Number of adverse events associated with the head-and-neck cooling treatment
Measured: Treatment to 72-hour follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start20 Feb 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TecTraum Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Reilly, MD, Principal investigator, Children's Hospital Medical Center of Akron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929923
- Sponsor's protocol ID
- 1380718
- Status last verified
- Aug 2026
- First submitted
- 14 Apr 2025
- Last updated
- 12 Aug 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 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized Study of Clinical Efficacy of Hypothermic Therapy Following Concussion in Adolescent Athletes as Compared to a Sham-Controlled Population
- ClinicalTrials.gov ID
- NCT06929923
- Acronym / sponsor ID
- 1380718
- Conditions
- Concussion, Mild
- Keywords
- Non-invasive hypothermic therapy, Sports-related concussion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- TecTraum Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 16 Apr 2025 (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 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.
Detailed description
This is a multi-center, prospective, randomized, double-blinded, dual-arm comparative study enrolling up to a total of 66 patients (approximately 33 patients in the treatment arm and 33 patients in the control arm) following sports-related, concussion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pro2Cool intervention with standard of care | Experimental | Device: Pro2Cool DeviceThe 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 Pro2Cool with standard of care | Sham comparator | Device: Sham Cooling Garment DeviceThe 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). |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Males and females, 13-21 years of age
- Confirmed concussion diagnosis consistent with American Congress Rehabilitation Medicine guidelines 21, without any of the following:
- Glasgow Coma Scale (GCS) ≥ 13 at the time of initial injury for study enrollment.
- Post-Concussion Symptom Scale Score minimum of 15
- Initial provider visit is within 7 days of injury
Key exclusion criteria (20 listed)
- Age < 13 years or > 21 years
- Inability to understand the study requirements or provide informed consent
- Cleared to return to play during initial visit
- Prior participation in a Pro2Cool Clinical Study
- Serious traumatic brain injury as evidenced by worsening symptoms:
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 |
|---|---|---|
| Pro2Cool DeviceThe 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. | Device | Pro2Cool intervention with standard of care |
| Sham Cooling Garment DeviceThe 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. | Device | Sham Pro2Cool with standard of care |
Primary outcome
Change quantified by post-concussion symptom severity (PCSS) assessment score
Time frame: Post-injury to 72-hour follow-up
1 secondary outcome
Number of adverse events associated with the head-and-neck cooling treatment
Time frame: Treatment to 72-hour follow-up
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 12 Aug 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.
Rebecca Zickert contact
Brian Reilly, MD principal investigator
Children's Hospital Medical Center of Akron
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pro2Cool Device in people with Concussion, Mild, run by TecTraum Inc. at 3 sites 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 10 inclusion and 20 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 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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 John Zak, MD, MBA (216-789-7676, jzak@tectraum.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change quantified by post-concussion symptom severity (PCSS) assessment score (time frame: Post-injury to 72-hour follow-up). 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 12 Aug 2026.