Multiple SclerosisCOMMITMENTNCT05561621
Prediction of Non-motor Symptoms in Fully Ambulatory MS Patients Using Vocal Biomarkers
An observational study of Multiple Sclerosis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The investigator will set up a study evaluating vocal biomarkers in people with MS in order to identify persons with non-motor symptoms: depression, cognitive deterioration, and fatigue. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Voice analysis
- How many people
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Jul 2022to 20 Dec 2022
- Phase
- Observational
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with relapsing MS and healthy controls
Who may be able to join
- Relapsing MS
- Age over 18
- EDSS < 4.0
- Capability of written informed consent
Who cannot join
- Not fluent in german language
- Relapse or Steroids per os/intra venous < 4 weeks prior to examination
- KM enhancing lesion in MRI < 4 weeks prior to examination
- Other previous disease affecting the speech
- Pregnant patients
- Mental disability and not able to understand the protocol and study tasks in german languagePatients with greater physical and cognitive disability or history of major depressive disorder and suicide attempt/suicidal thoughts
- Patients with sleep disorders and comorbidities associated with extreme fatigue (e.g., fibromyalgia)
Trial locations and contacts
1 site in 1 country.
About this study
The investigator will set up a study evaluating vocal biomarkers in people with MS in order to identify persons with non-motor symptoms: depression, cognitive deterioration, and fatigue. Up to now, to the best of the investigator's knowledge, there is no study reporting the use of vocal biomarkers to predict these three non-motor symptoms in people with MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Voice analysis
- Keywords
- Multiple Sclerosis, Digital Biomarker, Non-Motor symptoms, Fatigue, Cognition, Depression, Voice Analysis
- Medical subject headings
- Multiple Sclerosis, Fatigue, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice analysisOther
Voice analysis
| Study group | Role | What they receive |
|---|---|---|
| Patients with relapsing MS | Not described Receives: Other: Voice analysis | |
| Healthy controls | Not described Receives: Other: Voice analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of a voice signature that separates between pwMS with and without fatigue
Measured: One year
Secondary outcomes (2)
Identification of a voice signature that separates between pwMS with and without cognitive impairment
Measured: One year
Identification of a voice signature that separates between pwMS with and without depression
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start15 Jul 2022
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Audeering GMBH, Biogen
- Responsible party
- Sponsor
- Investigators
- Helly Hammer, Principal investigator, Inselspital, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561621
- Sponsor's protocol ID
- DLF5177
- Acronym
- COMMITMENT
- Status last verified
- Jun 2023
- First submitted
- 27 Sep 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Non-motor Symptoms in Fully Ambulatory MS Patients Using Vocal Biomarkers
- ClinicalTrials.gov ID
- NCT05561621
- Acronym / sponsor ID
- COMMITMENT / DLF5177
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Digital Biomarker, Non-Motor symptoms, Fatigue, Cognition, Depression, Voice Analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Audeering GMBH, Biogen
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 30 Sep 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 investigator will set up a study evaluating vocal biomarkers in people with MS in order to identify persons with non-motor symptoms: depression, cognitive deterioration, and fatigue. Up to now, to the best of the investigator's knowledge, there is no study reporting the use of vocal biomarkers to predict these three non-motor symptoms in people with MS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with relapsing MS | – | Other: Voice analysis |
| Healthy controls | – | Other: Voice analysis |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with relapsing MS and healthy controls
Key inclusion criteria (4 listed)
- Relapsing MS
- Age over 18
- EDSS < 4.0
- Capability of written informed consent
Key exclusion criteria (7 listed)
- Not fluent in german language
- Relapse or Steroids per os/intra venous < 4 weeks prior to examination
- KM enhancing lesion in MRI < 4 weeks prior to examination
- Other previous disease affecting the speech
- Pregnant patients
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 |
|---|---|---|
| Voice analysisVoice analysis | Other | Healthy controls, Patients with relapsing MS |
Primary outcome
Identification of a voice signature that separates between pwMS with and without fatigue
Time frame: One year
2 secondary outcomes
Identification of a voice signature that separates between pwMS with and without cognitive impairment
Time frame: One year
Identification of a voice signature that separates between pwMS with and without depression
Time frame: One year
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 15 Jun 2023.
- 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.
Helly Hammer principal investigator
Inselspital, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 4 inclusion and 7 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 15 Jun 2023. 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 Switzerland. 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?
Identification of a voice signature that separates between pwMS with and without fatigue (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2023.