Chronic Pain After Combat-Related Traumatic Brain Injury (cTBI-Pain Study) A Prospective Cohort Study of Pain Chronification After Combat-Related Traumatic Brain Injury

NCT07424248 | Not Yet Recruiting

• 1 other identifier: 09v313022026
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain; Chronic Pain; Chronic Pain Due to Injury

Keywords

Combat-related traumatic brain injury; cTBI; Blast injury; Chronic pain; Neuropathic pain; Sleep disturbance; Pain prediction; Military trauma

Outcome Measures

Primary Outcomes (1)

• Clinically significant chronic pain at 3 months after injury.

  Clinically significant chronic pain is defined as pain intensity ≥4 on the 0-10 Numerical Rating Scale (NRS) and/or pain interference score ≥4 on the Brief Pain Inventory (BPI) at 3 months post-injury. The proportion of participants meeting this definition will be calculated, and predictors of chronic pain will be evaluated using multivariable modeling.

  From injury to 3 months (±2 weeks) post-injury.

Secondary Outcomes (2)

• Clinically significant chronic pain at 6 months

  6 months (±3 weeks) after injury

• Neuropathic pain phenotype

  3 and 6 months after injury

Study Arms (1)

Combat-Related TBI Cohort

Adults aged 18-60 years with mild to moderate combat-related traumatic brain injury enrolled within 14 days of injury. Participants will undergo standardized clinical, psychological, and pain assessments and will be followed prospectively for 6 months to evaluate the development of chronic pain.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18-60 years with mild to moderate combat-related traumatic brain injury (blast, impact, or combined mechanism) presenting to participating trauma and rehabilitation centers in Ukraine. Participants will be enrolled within 14 days of injury and followed prospectively for 6 months to assess the development of chronic pain and related psychological and functional outcomes.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans): lead

Study Sites (1)

Superhumans War Trauma Center

Lviv, Ukraine

Location

MeSH Terms

Conditions

Pain; Chronic Pain; Blast Injuries; Neuralgia; Parasomnias

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Barotrauma; Wounds and Injuries; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Sleep Wake Disorders; Mental Disorders

Central Study Contacts

Dmytro Dmytriiev, PhD.Professor

CONTACT

+380674309449; d.dmytriiev@superhumans.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2026
• First Posted: February 20, 2026
• Study Start: February 15, 2026
• Primary Completion: February 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)