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Digital Solutions for Concussion (DiSCo)

Primary Purpose

Post-Concussion Syndrome, Post-Traumatic Headache

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Digital symptom mapping and biofeedback treatment
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post-Concussion Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Olavs Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Digital symptom mapping and biofeedback treatment

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 2, 2022
Last Updated
April 11, 2023
Sponsor
St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05635656
Brief Title
Digital Solutions for Concussion
Acronym
DiSCo
Official Title
Digital Symptom Mapping and Home-based Biofeedback Treatment for Adults With Persistent Postconcussion Symptoms: a Development and Usability Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 25, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Concussion Syndrome, Post-Traumatic Headache

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Digital symptom mapping and biofeedback treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Digital symptom mapping and biofeedback treatment
Intervention Description
Digital symptom mapping and biofeedback treatment
Primary Outcome Measure Information:
Title
Usability of new digital solutions for symptom mapping and home-based biofeedback treatment in patients with PPCS/PTH
Description
- 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
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).
Secondary Outcome Measure Information:
Title
Feasibility and adherence of new digital solutions
Description
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
Time Frame
Will be assessed after the home-testing period (T3)
Other Pre-specified Outcome Measures:
Title
Safety of new digital solutions
Description
Description of the frequency and severity of adverse events, serious adverse events and unexpected serious adverse events
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
St. Olavs Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Digital Solutions for Concussion

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