← Back to all trials
Recruiting
NCT05635656
Digital Solutions for Concussion
Conditions: Post-Concussion Syndrome, Post-Traumatic Headache
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 20
Sponsor: St. Olavs Hospital
Location: Norway
Summary
The objective of this study is to develop new digital solutions for patients with prolonged postconcussion symptoms, and investigate its usability, feasibility, and safety.
The digital solutions consist of a 1) symptom mapping and clinical decision support system, and 2) a research-based system for home-based biofeedback treatment.
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 consentExclusion 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 smartphonesNot having access to an iOS or Android smartphone
Source: ClinicalTrials.gov (NCT05635656). StuddyBuddy aggregates publicly available trial information.