Digital Solutions for Concussion (DiSCo)

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

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 Overview

• Status: Active, not recruiting
• Conditions: Post-Concussion Syndrome; Post-Traumatic Headache
• Intervention / Treatment: Device: Digital symptom mapping and biofeedback treatment

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • St. Olavs Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital symptom mapping and biofeedback treatment	Device: Digital symptom mapping and biofeedback treatment; Digital symptom mapping and biofeedback treatment

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).

Collaborators and Investigators

• Sponsor: St. Olavs Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: November 22, 2022
• First Posted (Actual): December 2, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Headache Disorders; Brain Concussion; Head Injuries, Closed; Wounds, Nonpenetrating; Headache Disorders, Secondary; Headache; Post-Concussion Syndrome; Post-Traumatic Headache
• Other Study ID Numbers: 422538

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No