Last reviewed · How we verify
NCT03511339
Pro-2-Cool Device Clinical Study
NA trial testing TecTraum device in Mild Traumatic Brain Injury in 174 participants. Completed in 29 May 2022.
27 April 2022
Quick facts
| Lead sponsor | TecTraum Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 174 |
| Start date | 4 November 2017 |
| Primary completion | 27 April 2022 |
| Estimated completion | 29 May 2022 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- TecTraum device
Conditions studied
- Mild Traumatic Brain Injury — all drugs for Mild Traumatic Brain Injury →
Sponsor
TecTraum Inc.
Who can join
Adults 12 to 21, any sex, with Mild Traumatic Brain Injury. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Reduced Concussion Symptom Burden in Early Adolescent Athletes Using a Head-Neck Cooling Device.
Smith MA, McNinch NL, Chaney D, Shauver L, et al · · 2024 · cited 4× · PMID 38180057 · DOI 10.1097/jsm.0000000000001198
Verify or expand the search:
- PubMed search for NCT03511339
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Mild Traumatic Brain Injury
Currently open trials in the same condition.
- NCT07246993 — Targeting Neuroplasticity for Persistent Post-Concussive Cognitive Symptoms · NA · recruiting
- NCT07356167 — Passive Neurosensory Reintegration Training as a Tool to Augment Mild Traumatic Brain Injury · NA · recruiting
- NCT07097792 — Concussion Recovery and Support Program · NA · recruiting
- NCT06956417 — REhabilitation of MEMory Symptoms After BRain Concussion · NA · recruiting
- NCT06217575 — Brain Research Assessing Impacts of Neurophysiological Processing Speed Training in Veterans · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03511339 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by TecTraum Inc.
- Last refreshed: 3 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03511339.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing