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OpenTrials
Completed

NCT Number: NCT05635656

Digital Solutions for Concussion

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.

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Key information

Conditions

Post-Concussion Syndrome Brain Concussion Brain Diseases Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Headache Disorders Headache Disorders, Secondary Nervous System Diseases Post-Traumatic Headache Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Olavs Hospital

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital symptom mapping and biofeedback treatment

Device

Digital symptom mapping and biofeedback treatment

Primary outcomes

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

    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).

    • 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 outcomes

  1. Feasibility and adherence of new digital solutions

    Time frame: 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

Other outcomes

  1. Safety of new digital solutions

    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).

    Description of the frequency and severity of adverse events, serious adverse events and unexpected serious adverse events

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Registry information

Official study title

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

Acronym: DiSCo

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 2, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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