Digital Solutions for Concussion

Not Applicable

Active, not recruiting

• Conditions: Post-Traumatic Headache; Post-Concussion Syndrome

• Registration Number: NCT05635656
• Lead Sponsor: St. Olavs Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-22
• Study Start: 2022-11-25
• Study First Posted: 2022-12-02
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Usability of new digital solutions for symptom mapping and home-based biofeedback treatment in patients with PPCS/PTH	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).	- 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

Secondary Outcome Measures

Name	Time	Method
Feasibility and adherence of new digital solutions	Will be assessed after the home-testing period (T3)	* 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

Trial Locations

Locations (1)

St. Olavs Hospital; 🇳🇴 Trondheim, Norway