Neuroprotective Efficacy of a Head-Neck Cooling Device Pertaining to the Cognitive and Somatic Sequelae from Subconcussive Impacts in European Participants of American Football – a pilot study

Neuroprotective Efficacy of a Head-Neck Cooling Device Pertaining to the Cognitive and Somatic Sequelae from Subconcussive Impacts in European Participants of American Football – a pilot study - COOLHEAD COOLing the HEAD to mitigate subconcussive effects in football players

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00037525

Enrollment

Registered

2025-08-11

Start date

2025-07-10

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic brain injury, particularly the subtype of sport-related concussion and subconcussive impacts

Interventions

Group 1: Intervention group: Application of the PolarCap® head-neck cooling device for 45 minutes after each contact training session or game. Group 2: Control group: No intervention

participants follow standard post-training/game routines.

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Offensive and defensive linemen, linebackers, and tight ends (all specialized position groups in American football) from the Hamburg Sea Devils (European League of Football).

Exclusion criteria

Exclusion criteria: Participants who sustain a physician-diagnosed traumatic brain injury, skull fracture, or cervical spine injury during the season will be excluded from the dataset analyzing cognitive function and somatic dysfunction. Additionally, participants must complete all three assessments throughout the study. Participant dropout (due to prolonged musculoskeletal injury preventing contact activity for more than three weeks, or due to personnel changes) will be documented. The prevalence rate of diagnosed traumatic brain injuries will be monitored throughout the study in both the control and intervention groups. Individuals with vertebral artery dysfunction, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, or Raynaud’s syndrome will also be excluded from participation.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is defined as a smaller decline in cognitive performance, measured using the computer-based neurocognitive test battery ImPACT™, compared to the control group.	—

Secondary

Measure	Time frame
The secondary endpoint is defined as a reduction in self-reported pain intensity (pain, headaches) and limitations in performing daily work-related activities (work, lifting, and concentration) as well as non-work-related activities (self-care, reading, driving, sleeping, and leisure), measured using the Neck Disability Index (NDI), compared to the control group.	—

Countries

Germany

Contacts

Public ContactMatthias Pagels

Studienzentrum Hochschule Döpfer Hamburg

m.pagels@hs-doepfer.de+49 40 696558 26

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026