Digital Solutions for Concussion

St. Olavs Hospital23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Post-Concussion Syndrome Post-Traumatic Headache

Interventions

Digital symptom mapping and biofeedback treatmentDEVICE

Digital symptom mapping and biofeedback treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

St. Olavs Hospital

Trondheim, Norway

Outcomes

Primary Outcomes

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

Time frame: 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 Outcomes

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

Time frame: Will be assessed after the home-testing period (T3)

Data from ClinicalTrials.gov

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