Digital Solutions for Concussion

Post-Concussion Syndrome Clinical Trial

— DiSCo  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05635656
• Other study ID #: 422538
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 25, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: April 2023
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Post-Concussion Syndrome
• Post-Traumatic Headache

Intervention

Device:
• Digital symptom mapping and biofeedback treatment
Digital symptom mapping and biofeedback treatment

Locations

Country	Name	City	State
Norway	St. Olavs Hospital	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety of new digital solutions	Description of the frequency and severity of adverse events, serious adverse events and unexpected serious adverse events	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).
Primary	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	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)