Early treatment of patients with post-traumatic complaints after mild traumatic brain injury

Multicentre early intervention study in adults with complaints after mild traumatic brain injury - Multicentre early intervention study in adults with complaints after mild traumatic brain injury

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON58046

Enrollment

657

Registered

2025-06-05

Start date

2026-02-24

Completion date

Unknown

Last updated

2026-03-09

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

Conditions

Mild traumatic brain injury, concussion

Interventions

At two weeks after injury post-traumatic complaints are assessed using the Rivermead Postconcussive symptoms Questionnaire (RPQ). If a predefined minimum of complaints is present, a patient is randomi

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Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All patients aged 18-70 years diagnosed with mTBI at the ED of one of the participating hospitals within 24 hours after trauma are eligible for inclusion. mTBI is defined as a traumatic injury to the head resulting in loss of consciousness (<30min.) and/or post-traumatic amnesia (<24hrs), and a Glasgow Coma Scale (GCS) score of 13-15 after initial surgical resuscitation at the ED. Comprehension of Dutch language is also an essential prerequisite for inclusion. 

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: inability for follow-up, chronic substance abuse (alcohol and/or drugs), severe psychiatric disease (for which the patient was admitted in the past), documented previous traumatic brain injury, dementia and/or other severe comorbidities, and language barriers or illiteracy prohibiting understanding and completion of questionnaires.

Design outcomes

Primary

Measure	Time frame
Primary outcome is expressed as the total RPQ sum score at three months post-injury, and cost-effectiveness in case of efficacy of (one of) the interventons under study at three and six months after-injury.	—

Secondary

Measure	Time frame
The secondary outcomes are functional outcome assessed with the Glasgow Outcome Scale Extended (GOSE) and quality of life measured with the Quality Of LIfe after BRain Injury-Overall Scale (QOLIBRI-OS) at three and six months post-injury, and RPG sum score at six months.	—

Countries

Netherlands

Contacts

Public ContactJ. Naalt

Universitair Medisch Centrum Groningen

secretariaat@neuro.umcg.nl050-3612400

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 14, 2026