Mild Traumatic Brain InjuryNCT03511339
Pro-2-Cool Device Clinical Study
A study testing TecTraum device in people with Mild Traumatic Brain Injury, run by TecTraum Inc. at 5 sites in United States.
Trial summary
This study is being conducted to quantify the clinical safety and efficacy of head and neck cooling when applied up to 8 days after mild traumatic brain injury (mTBI) among adolescents participating in sporting activities. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- TecTraum device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 5 sitesUnited States
- Study dates
- 4 Nov 2017to 29 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and females ages 12 - 21 years
- Initial provider visit is within 8 days of mTBI injury
- Confirmed mTBI diagnosis from sporting activities
- In generally good health as confirmed by medical history and as determined by site investigator
- Has a symptom score of at least 7 (analogous of the SCAT5 symptoms score)
- Has informed consent obtained per protocol and as required per Institutional Review Board (IRB)
Who cannot join
- Cleared to return to play during initial visit
- Suffers a serious TBI as evidenced by worsening symptoms, specifically:
- Seizure
- Hospitalization
- Existing positive diagnostic testing, which include radiology scans that indicate brain bleed
- Slurred speech, which has not resolved within 72 hours of mTBI injury
Show all 17Show fewer
- Sustains another head or neck injury at the time of mTBI injury which requires medical treatment
- Known or disclosed pregnancy or breast-feeding
- History of a serious medical or psychiatric disorder that include:
- Suicide attempt in the last 6 months
- Unmanaged depression or anxiety
- Hospitalization in the last 6 months for psychiatric treatment
- History of Reynaud's disease or phenomenon, cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia
- Previously diagnosed with a cerebrovascular disorder
- Is unable to understand the study requirements or the informed consent
- Currently enrolled in another investigational research study that may confound the results of this study
- Non-English speaking subjects and parents/legal guardians
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Akron Children's Hospital
Akron, Ohio, 44308-1062
University of Michigan - Michigan Medicine
Ann Arbor, Michigan, 48108
Akron Children's Hospital, Mahoning Valley Campus
Boardman, Ohio, 44512
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Dayton Children's Hospital
Dayton, Ohio, 45404
About this study
Official title: Pro-2-Cool Device Clinical Study: an Assessment of Clinical Efficacy of Hypothermic Therapy Following Mild Traumatic Brain Injury (mTBI) in the Adolescent Athlete as Compared to an Untreated Active Control Population
This study is being conducted to quantify the clinical safety and efficacy of head and neck cooling when applied up to 8 days after mild traumatic brain injury (mTBI) among adolescents participating in sporting activities.
Read the detailed description
This is a single-center, prospective, randomized, non-blinded, dual-arm comparator study that will include two-phases, the 60-patient pilot study (30 patients in the treatment arm and 30 patients in the control arm) followed by a pivotal study (up to 200 patients in the treatment and control arm combined) for a total of up to 260 patients overall in both phases. The pilot study will serve as an opportunity to assess the protocol and make adjustments, if necessary. In addition, descriptive statistics including effect size will be calculated and the safety of the device will be assessed at the conclusion of the pilot study.
Subjects will be assigned to study arm based on a block randomization schedule generated a priori.
The study sponsor believes that the device and therapeutic treatment that will be evaluated in this study is a non-significant risk (NSR) to the subjects.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- TecTraum device
- Keywords
- Concussion, TBI, mTBI
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TecTraum deviceDevice
Also called Pro-2-Cool
A non-invasive hypothermic therapy ("cold therapy") TecTraum device that provides localized cooling of the head and neck.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Brain rest |
| TecTraum Device | Experimental | Treatment with study device Receives: Device: TecTraum device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The SCAT5 overall score will be collected at the initial visit in the Sports Medicine Clinic, and compared to follow-up visits throughout the study, with the objective of demonstrating better outcomes in the treatment group compared to the control group.
Formal statistical hypothesis testing will be employed in the evaluation of this endpoint.
Additionally, comparisons between treatment groups on the baseline SCAT5 (SCAT5-PRE) will be performed at initial visit (as reported by subject) and at each follow-up (72 hours, 10 days, and 4 weeks) separately to evaluate the time trend in recovery. Individual SCAT5 symptoms, each scored on a scale of 0-6, will also be summarized and compared by treatment group to investigate the effect of treatment on specific symptoms. These comparisons are intended to provide additional information on the pattern of recovery and are not attached to intended labeling claims; however, statistical testing of these endpoints will be accompanied by adjustment for multiplicity using the Hochberg-Holm method.
Measured: Change from initial visit to 4 weeks
Secondary outcomes (1)
Recovery time from initial visit, summarized by group and compared in the treatment group to control.
Recovery time from initial visit will be formally evaluated for differences between treatment and control.
Measured: Initial visit through earliest follow up where complete recovery is observed, maximum of 4 weeks after initial visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start4 Nov 2017
- Primary completion27 Apr 2022
- Study completion29 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Traumatic Brain InjuryStudies 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
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- TecTraum Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners, Akron Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Joseph Congeni, MD, Principal investigator, Akron Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511339
- Sponsor's protocol ID
- 1289670
- Status last verified
- May 2023
- First submitted
- 30 Mar 2018
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Congeni J, Murray T, Kline P, Bouhenni R, Morgan D, Liebig C, Lesak A, McNinch NL. Preliminary Safety and Efficacy of Head and Neck Cooling Therapy After Concussion in Adolescent Athletes: A Randomized Pilot Trial. Clin J Sport Med. 2022 Jul 1;32(4):341-347. doi: 10.1097/JSM.0000000000000916. Epub 2021 Mar 10.
PubMed 34009790
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pro-2-Cool Device Clinical Study: an Assessment of Clinical Efficacy of Hypothermic Therapy Following Mild Traumatic Brain Injury (mTBI) in the Adolescent Athlete as Compared to an Untreated Active Control Population
- ClinicalTrials.gov ID
- NCT03511339
- Acronym / sponsor ID
- 1289670
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- Concussion, TBI, mTBI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- TecTraum Inc.Industry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners, Akron Children's Hospital
- Study start
- 4 Nov 2017 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 29 May 2022 (actual)
- First posted
- 27 Apr 2018 (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 quantify the clinical safety and efficacy of head and neck cooling when applied up to 8 days after mild traumatic brain injury (mTBI) among adolescents participating in sporting activities.
Detailed description
This is a single-center, prospective, randomized, non-blinded, dual-arm comparator study that will include two-phases, the 60-patient pilot study (30 patients in the treatment arm and 30 patients in the control arm) followed by a pivotal study (up to 200 patients in the treatment and control arm combined) for a total of up to 260 patients overall in both phases. The pilot study will serve as an opportunity to assess the protocol and make adjustments, if necessary. In addition, descriptive statistics including effect size will be calculated and the safety of the device will be assessed at the conclusion of the pilot study.
Subjects will be assigned to study arm based on a block randomization schedule generated a priori.
The study sponsor believes that the device and therapeutic treatment that will be evaluated in this study is a non-significant risk (NSR) to the subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Brain rest |
| TecTraum Device | Experimental | Device: TecTraum deviceTreatment with study device |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Males and females ages 12 - 21 years
- Initial provider visit is within 8 days of mTBI injury
- Confirmed mTBI diagnosis from sporting activities
- In generally good health as confirmed by medical history and as determined by site investigator
- Has a symptom score of at least 7 (analogous of the SCAT5 symptoms score)
Key exclusion criteria (17 listed)
- Cleared to return to play during initial visit
- Suffers a serious TBI as evidenced by worsening symptoms, specifically:
- Seizure
- Hospitalization
- Existing positive diagnostic testing, which include radiology scans that indicate brain bleed
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 |
|---|---|---|
| TecTraum deviceAlso: Pro-2-CoolA non-invasive hypothermic therapy ("cold therapy") TecTraum device that provides localized cooling of the head and neck. | Device | TecTraum Device |
Primary outcome
The SCAT5 overall score will be collected at the initial visit in the Sports Medicine Clinic, and compared to follow-up visits throughout the study, with the objective of demonstrating better outcomes in the treatment group compared to the control group.
Time frame: Change from initial visit to 4 weeks
Formal statistical hypothesis testing will be employed in the evaluation of this endpoint. Additionally, comparisons between treatment groups on the baseline SCAT5 (SCAT5-PRE) will be performed at initial visit (as reported by subject) and at each follow-up (72 hours, 10 days, and 4 weeks) separately to evaluate the time trend in recovery. Individual SCAT5 symptoms, each scored on a scale of 0-6, will also be summarized and compared by treatment group to investigate the effect of treatment on specific symptoms. These comparisons are intended to provide additional information on the pattern of recovery and are not attached to intended labeling claims; however, statistical testing of these endpoints will be accompanied by adjustment for multiplicity using the Hochberg-Holm method.
1 secondary outcome
Recovery time from initial visit, summarized by group and compared in the treatment group to control.
Time frame: Initial visit through earliest follow up where complete recovery is observed, maximum of 4 weeks after initial visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Results publication: PubMed 34009790Congeni J, Murray T, Kline P, Bouhenni R, Morgan D, Liebig C, Lesak A, McNinch NL. Preliminary Safety and Efficacy of Head and Neck Cooling Therapy After Concussion in Adolescent Athletes: A Randomized Pilot Trial. Clin J Sport Med. 2022 Jul 1;32(4):341-347. doi: 10.1097/JSM.0000000000000916. Epub 2021 Mar 10.
- TecTraum website with video describing trial.Link provided by the sponsor.
- 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. This study is not recruiting at the moment.
Joseph Congeni, MD principal investigator
Akron Children's Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TecTraum device in people with Mild Traumatic Brain Injury, run by TecTraum Inc. at 5 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 6 inclusion and 17 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: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The SCAT5 overall score will be collected at the initial visit in the Sports Medicine Clinic, and compared to follow-up visits throughout the study, with the objective of demonstrating better outcomes in the treatment group compared to the control group. (time frame: Change from initial visit to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03511339, which also lists 1 linked publication.
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 3 May 2023.