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

NCT ID: NCT05561621

Last Updated: 2023-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-15

Study Completion Date

2022-12-20

Brief Summary

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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

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with relapsing MS

Voice analysis

Intervention Type OTHER

Voice analysis

Healthy controls

Voice analysis

Intervention Type OTHER

Voice analysis

Interventions

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Voice analysis

Voice analysis

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Audeering GMBH

INDUSTRY

Sponsor Role collaborator

Biogen

INDUSTRY

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Helly Hammer

Role: PRINCIPAL_INVESTIGATOR

Inselspital, University Hospital Bern

Locations

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Inselspital University Hospital Bern

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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DLF5177

Identifier Type: -

Identifier Source: org_study_id

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