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:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT05635656
Eligibility Criteria:
Inclusion Criteria:
* 18 or older at the time of inclusion.
* Mild TBI as defined by having sustained a head injury with observed or self-reported alteration of consciousness, amnesia, or other relevant acute symptoms.
* PPCS according to the ICD-10 research criteria and PTH according to International Classification of Headache Disorders 3rd edition (ICHD-3). Operationalized as reporting 3 or more symptoms (including headache) on a moderate or greater intensity level on the RPSQ.
* Proficient in Norwegian language (oral and written)
* Signed informed consent
Exclusion Criteria:
* Serious psychiatric or somatic disease, or other patient-related factors, that based on an evaluation of the study personnel responsible for inclusion, will provide obvious challenges for adhering to the protocol, including using the devices.
* Less than three months of experience with smartphones
* Not having access to an iOS or Android smartphone
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05635656
Study Brief:
Protocol Section:
NCT05635656