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

NCT05561621 | Completed

• 1 other identifier: DLF5177
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Digital Biomarker; Non-Motor symptoms; Fatigue; Cognition; Depression; Voice Analysis

Outcome Measures

Primary Outcomes (1)

• Identification of a voice signature that separates between pwMS with and without fatigue

  One year

Secondary Outcomes (2)

• Identification of a voice signature that separates between pwMS with and without cognitive impairment

  One year

• Identification of a voice signature that separates between pwMS with and without depression

  One year

Study Arms (2)

Patients with relapsing MS

Other: Voice analysis

Healthy controls

Other: Voice analysis

Interventions

Voice analysis OTHER

Voice analysis

Healthy controls; Patients with relapsing MS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with relapsing MS and healthy controls

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Audeering GMBH: collaborator
• Biogen: collaborator

Study Sites (1)

Inselspital University Hospital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue; Depression

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Helly Hammer

  Inselspital, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: September 30, 2022
• Study Start: July 15, 2022
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)