Clinical trial Recruiting at 1 site Interventional Ages 18 to 70

Early Intervention for Adults with Ongoing Post-Concussion Symptoms after Mild TBI

Official title: BRAin INjury REcovery After Symptom-guided Early Therapy

Run by University Medical Center Groningen · NCT07341074 · Data updated 2026-11-12

This study tests a package of physical/occupational therapy and telephonic psychoeducation to help adults recover after a mild traumatic brain injury.

Quick facts

Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment655 (estimated)
SponsorUniversity Medical Center Groningen
Academic / other
Locations1 site (Groningen)
StatusRecruiting
StartedFebruary 16, 2026
Main results expectedOctober 1, 2027
Study endsDecember 31, 2027
Registry record updatedJune 26, 2026
Trial IDNCT07341074 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18–70 with mild TBI seen within 24 hours of injury, with brief loss of consciousness or amnesia and a GCS of 13–15 after stabilization, who can understand Dutch.

Probably not a fit

Individuals with ongoing follow-up difficulties or contraindications to physical/occupational therapy may derive little or no benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter study targets adults aged 18 to 70 who have recently visited the ED for mild traumatic brain injury and continue to experience post-traumatic complaints. Participants receive therapy from physical and/or occupational therapists along with telephonic psychoeducation to help manage symptoms and improve daily functioning. The aim is to see if this early, structured intervention can reduce persistent post-concussion symptoms and facilitate a faster return to work or normal activities. The trial is conducted at the University Medical Center Groningen in the Netherlands, enrolling individuals who meet defined clinical criteria and language requirements. Outcomes focus on recovery trajectory, functional status, and quality of life in the months following injury.

Why it matters

Potential benefit: If successful, participants may experience reduced post-concussion symptoms and better ability to resume daily activities and work sooner.

How similar studies have gone: Prior research suggests early rehabilitation approaches can help post-concussion symptoms, but results vary and this protocol adds telephonic psychoeducation to the mix.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age 18-70 years
* Seen at the ED within 24 hours after trauma
* Loss of consciousness (\<30min.)
* Post-traumatic amnesia (\<24hrs)
* Glasgow Coma Scale (GCS) score of 13-15 after initial resuscitation at the ED
* Comprehension of Dutch language

Exclusion Criteria:

* Inability for follow-up
* Chronic substance abuse (alcohol and/or drugs)
* Severe psychiatric disease
* Documented previous traumatic brain injury for which the patient was admitted
* Dementia and/or other severe comorbidities
* Current treatment by physical and/or occupational therapist for other indications
* Language barriers or illiteracy prohibiting understanding and completion of questionnaires

Where it's running

  • University Medical Center Groningen
    Groningen, Netherlands
    Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.