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DiSCo: Digital Solutions for Concussion

Sponsor
St. Olavs Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05635656
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
12
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Digital symptom mapping and biofeedback treatment
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Digital Symptom Mapping and Home-based Biofeedback Treatment for Adults With Persistent Postconcussion Symptoms: a Development and Usability Study
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Digital symptom mapping and biofeedback treatment

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Other Outcome Measures

  1. Safety of new digital solutions [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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). Operatized 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Olavs Hospital Trondheim Norway

Sponsors and Collaborators

  • St. Olavs Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT05635656
Other Study ID Numbers:
  • 422538
First Posted:
Dec 2, 2022
Last Update Posted:
Dec 2, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Post-Concussion Syndrome
Post-Traumatic Headache
Headache

Study Results

No Results Posted as of Dec 2, 2022