| NCT ID | NCT05233475 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Brain Concussion |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-02-13 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-02-13 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Concussion affects around 25 000 people each year in Denmark. A large research initiative (GAIN 2.0) has been established, and the current study is a part of this initiative. Aims: 1. To develop and test the efficacy of a novel intervention for people with persistent post-concussional mild-to-moderate symptoms: "Get going After concussion Lite" (GAIN Lite). 2. To increase the knowledge about the target group by investigating the association of physical activity, digital behaviour, and symptom load. Methods: A randomized controlled trial, comparing GAIN Lite to enhanced usual care. 100 adults diagnosed with a concussion at hospitals in Central Denmark Region or referred from general practitioners will be recruited. GAIN Lite is a digital intervention, and the primary outcome is the severity of post-concussional symptoms. A prospective cohort study will be performed to investigate the association between physical activity, cognitive processing, and symptom load.
Eligibility Criteria
Inclusion Criteria: 1. Concussion caused by a head trauma according to the diagnostic criteria recommended by the Danish Consensus Report on Commotio Cerebri (26). The criteria are based on recommendations by the WHO Task Force, but with the amendment, that there must have been a direct contact between the head and an object in order to rule out acceleration - deceleration traumas; 2. Age 18 to 60 years at the time of the trauma; 3. A total score of 10-30 on RPQ within 1 week before enrolment in the study; 4. Able to understand, speak and read Danish; 5. Living in Central Denmark Region; 6. Identified from registers of the emergency departments or referred by GPs to GAIN Lite within 2-4 months after a concussion Exclusion Criteria: 1. Objective neurological findings and/or acute trauma CT scan indicating neurological disease or brain damage linked to the concussion, if performed; 2. Previous concussion within the last 2 years with ongoing PCS at the time of the present concussion 3. Severe misuse of alcohol, prescription drugs and/or illegal drugs 4. Severe psychiatric co-morbidity (e.g. bipolar disorder, autism, psychotic disorder (life time)) or severe neurological disease (e.g. multiple sclerosis) that impedes participation in the programme.
Contact & Investigator
Sedsel Pedersen, PhD student
PRINCIPAL INVESTIGATOR
Hammel Neurorehabilitation Centre and University Research Clinic
Frequently Asked Questions
Who can join the NCT05233475 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Brain Concussion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05233475 currently recruiting?
Yes, NCT05233475 is actively recruiting participants. Contact the research team at sedped@rm.dk for enrollment information.
Where is the NCT05233475 trial being conducted?
This trial is being conducted at Hammel, Denmark.
Who is sponsoring the NCT05233475 clinical trial?
NCT05233475 is sponsored by University of Aarhus. The principal investigator is Sedsel Pedersen, PhD student at Hammel Neurorehabilitation Centre and University Research Clinic. The trial plans to enroll 100 participants.