Post-Concussion SyndromeDiSCoNCT05635656
Digital Solutions for Concussion
A study testing Digital symptom mapping and biofeedback treatment in people with Post-Concussion Syndrome and Post-Traumatic Headache, run by St. Olavs Hospital at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Concussion Syndrome, Post-Traumatic Headache
- What is being tested?
- Digital symptom mapping and biofeedback treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteNorway
- Study dates
- 25 Nov 2022to 5 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Post-Concussion Syndrome, Post-Traumatic Headache
- Being tested
- Digital symptom mapping and biofeedback treatment
- Medical subject headings
- Post-Concussion Syndrome, Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital symptom mapping and biofeedback treatmentDevice
Digital symptom mapping and biofeedback treatment
| Study group | Role | What they receive |
|---|---|---|
| Digital symptom mapping and biofeedback treatment | Experimental | Not described Receives: Device: Digital symptom mapping and biofeedback treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 outcomes (1)
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
Measured: Will be assessed after the home-testing period (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start25 Nov 2022
- Primary completion5 Mar 2024
- Study completion5 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Concussion SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635656
- Sponsor's protocol ID
- 422538
- Acronym
- DiSCo
- Status last verified
- Apr 2023
- First submitted
- 2 Nov 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Storvig G, Stubberud A, Rauwenhoff J, Ronhovde LM, Smits M, Saksvik SB, Skandsen T, Tronvik E, Olsen A. Mobile Health App for Adults with Persisting Postconcussion Symptoms: Development and Usability Study. JMIR Hum Factors. 2025 Nov 4;12:e75323. doi: 10.2196/75323.
PubMed 41187263
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Symptom Mapping and Home-based Biofeedback Treatment for Adults with Persistent Postconcussion Symptoms: a Development and Usability Study
- ClinicalTrials.gov ID
- NCT05635656
- Acronym / sponsor ID
- DiSCo / 422538
- Conditions
- Post-Concussion Syndrome, Post-Traumatic Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital symptom mapping and biofeedback treatment | Experimental | Device: Digital symptom mapping and biofeedback treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital symptom mapping and biofeedback treatmentDigital symptom mapping and biofeedback treatment | Device | Digital symptom mapping and biofeedback treatment |
Primary outcome
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
1 secondary outcome
Feasibility and adherence of new digital solutions
Time frame: Will be assessed after the home-testing period (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 41187263Storvig G, Stubberud A, Rauwenhoff J, Ronhovde LM, Smits M, Saksvik SB, Skandsen T, Tronvik E, Olsen A. Mobile Health App for Adults with Persisting Postconcussion Symptoms: Development and Usability Study. JMIR Hum Factors. 2025 Nov 4;12:e75323. doi: 10.2196/75323.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital symptom mapping and biofeedback treatment in people with Post-Concussion Syndrome and Post-Traumatic Headache, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05635656, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.