Chronic Pain After Combat-Related Traumatic Brain Injury (cTBI-Pain Study) A Prospective Cohort S… (NCT07424248) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Chronic Pain After Combat-Related Traumatic Brain Injury (cTBI-Pain Study) A Prospective Cohort Study of Pain Chronification After Combat-Related Traumatic Brain Injury
Ukraine100 participantsStarted 2026-02-15
Plain-language summary
Combat-related traumatic brain injury (cTBI), particularly blast-related injury, is frequently associated with the development of persistent and disabling chronic pain. This prospective observational cohort study aims to determine the incidence, phenotypes, and early predictors of chronic pain following mild to moderate combat-related TBI. Adults will be enrolled within 14 days of injury and followed for 6 months. The primary endpoint is clinically significant chronic pain at 3 months, defined by pain intensity and functional interference. The study will evaluate clinical, psychological, and physiological factors to develop and internally validate a prognostic model for chronic pain risk after cTBI.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 to 60 years
* Combat-related traumatic brain injury (blast, impact, or combined mechanism)
* Mild to moderate traumatic brain injury
* Enrollment within 14 days after injury
* Ability to provide written informed consent
Exclusion Criteria:
* Severe traumatic brain injury with prolonged impaired consciousness
* Pre-existing severe psychiatric disorder unrelated to trauma
* Chronic pain condition predating the traumatic brain injury
* Inability to complete follow-up assessments
* Severe medical condition limiting participation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinically significant chronic pain at 3 months after injury.
Timeframe: From injury to 3 months (±2 weeks) post-injury.
Trial details
NCT IDNCT07424248
SponsorCharitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)