Prediction of Non-motor Symptoms in Fully Ambulatory MS Patients Using Vocal Biomarkers (COMMITMENT)

June 13, 2023 updated by: Insel Gruppe AG, University Hospital Bern
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital University Hospital Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with relapsing MS and healthy controls

Description

Inclusion Criteria:

  • Relapsing MS
  • Age over 18
  • EDSS < 4.0
  • Capability of written informed consent

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with relapsing MS
Other: Voice analysis
Voice analysis
Healthy controls
Other: Voice analysis
Voice analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identification of a voice signature that separates between pwMS with and without fatigue
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Identification of a voice signature that separates between pwMS with and without cognitive impairment
Time Frame: One year
One year
Identification of a voice signature that separates between pwMS with and without depression
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Insel Gruppe AG, University Hospital Bern

Collaborators

Biogen
AUDEERING GMBH

Investigators

  • Principal Investigator: Helly Hammer, Inselspital, University Hospital Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2022

Primary Completion (Actual)

December 20, 2022

Study Completion (Actual)

December 20, 2022

Study Registration Dates

First Submitted

September 27, 2022

First Submitted That Met QC Criteria

September 27, 2022

First Posted (Actual)

September 30, 2022

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DLF5177

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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