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

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Voice analysis

• Registration Number: NCT05561621
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-15
• Study First Submitted: 2022-09-27
• Study First Submitted QC: 2022-09-27
• Study First Posted: 2022-09-30
• Primary Completion: 2022-12-20
• Study Completion: 2022-12-20
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-13
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with relapsing MS	Voice analysis	-
Healthy controls	Voice analysis	-

Primary Outcome Measures

Name	Time	Method
Identification of a voice signature that separates between pwMS with and without fatigue	One year

Secondary Outcome Measures

Name	Time	Method
Identification of a voice signature that separates between pwMS with and without depression	One year
Identification of a voice signature that separates between pwMS with and without cognitive impairment	One year

Trial Locations

Locations (1)

Inselspital University Hospital Bern; 🇨🇭 Bern, Switzerland