Status:
RECRUITING
Get Going After concussIonN Lite
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Hammel Neurorehabilitation Centre and University Research Clinic
Health Research Foundation of Central Denmark Region
Conditions:
Brain Concussion
Mild Traumatic Brain Injury
Eligibility:
All Genders
18-60 years
Phase:
NA
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. T...
Detailed Description
Get going After concussIonN Lite (GAIN Lite): An digital intervention to reduce impairing post-concussional mild-to-moderate symptoms in adults Background: Concussion, the mildest form of traumatic ...
Eligibility Criteria
Inclusion
- 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;
- Age 18 to 60 years at the time of the trauma;
- A total score of 10-30 on RPQ within 1 week before enrolment in the study;
- Able to understand, speak and read Danish;
- Living in Central Denmark Region;
- Identified from registers of the emergency departments or referred by GPs to GAIN Lite within 2-4 months after a concussion
Exclusion
- Objective neurological findings and/or acute trauma CT scan indicating neurological disease or brain damage linked to the concussion, if performed;
- Previous concussion within the last 2 years with ongoing PCS at the time of the present concussion
- Severe misuse of alcohol, prescription drugs and/or illegal drugs
- 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.
Key Trial Info
Start Date :
February 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05233475
Start Date
February 13 2023
End Date
September 30 2027
Last Update
April 2 2025
Active Locations (1)
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1
Hammel Neurorehabilitation Centre and University Research Clinic
Hammel, Deb´nmark, Denmark, 8450