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

Multiple Sclerosis Clinical Trial

— COMMITMENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05561621
• Other study ID #: DLF5177
• Status: Completed
• Start date: July 15, 2022
• Est. completion date: December 20, 2022

Study information

• Verified date: June 2023
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Voice analysis
Voice analysis

Locations

Country	Name	City	State
Switzerland	Inselspital University Hospital Bern	Bern

Sponsors (3)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern	AUDEERING GMBH, Biogen

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of a voice signature that separates between pwMS with and without fatigue		One year
Secondary	Identification of a voice signature that separates between pwMS with and without cognitive impairment		One year
Secondary	Identification of a voice signature that separates between pwMS with and without depression		One year