Digital Solutions for Concussion

Study Overview
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Brief Summary
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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.

Official Title
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Digital Symptom Mapping and Home-based Biofeedback Treatment for Adults With Persistent Postconcussion Symptoms: a Development and Usability Study

Conditions
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Post-Concussion Syndrome, Post-Traumatic Headache

Intervention / Treatment
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* Device: Digital symptom mapping and biofeedback treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital symptom mapping and biofeedback treatment<br> | Device: Digital symptom mapping and biofeedback treatment<br>* Digital symptom mapping and biofeedback treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability of new digital solutions for symptom mapping and home-based biofeedback treatment in patients with PPCS/PTH | - Description mHealth App Usability Questionnaire scores in the target user group; and Mobile App Rating Scale scores by an independent group of clinicians and researchers | Will be assessed at three different time points: After each usability testing during the iterative development cycles (T1 and T2) and after the home-testing period (T3). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and adherence of new digital solutions | Number of days with logged symptom data during a 4-week home-testing period Number of biofeedback sessions and mean change in biofeedback scores throughout the testing period | Will be assessed after the home-testing period (T3) |