Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT02350894
Eligibility Criteria:
Inclusion Criteria:
* Concussion caused by a head trauma according to the diagnostic criteria recommended by the Danish Consensus Report on Commotio Cerebri within the last 2-6 months. 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 pure acceleration - deceleration traumas.
* Age 18 to 30 years at the time of the head trauma.
* Able to understand, speak and read Danish.
* Patients with symptoms on at least three items on the Rivermead Post Concussion Symptoms Questionnaire (RPQ) rated as moderate or severe problem. PCS have to be subjectively rated as causing substantial impairment in daily life.
* Suitable for MRI examination
Exclusion Criteria:
* Objective neurological findings from neurological examination and / or acute trauma CT scan, indicating other neurological diseases or brain damage.
* Previous concussion leading to persistent PCS within the last two years.
* Severe abuse of alcohol, prescription drugs and / or illegal drugs.
* Psychiatric morbidity or severe neurological disease that impedes participation in the treatment, i.e. Bipolar Disorder, autism, psychotic disorder (lifetime), multiple sclerosis etc.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
30 Years
Study:
NCT02350894
Study Brief:
Protocol Section:
NCT02350894