Prediction of Non-motor Symptoms in Fully Ambulatory MS P... | NCT05561621

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

NCT05561621

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Completed

Last Update Posted

Jun 15, 2023Actual

Enrollment

70Actual

Phase

Not provided

Conditions

Multiple Sclerosis

Interventions

Voice analysis

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2022Actual

Primary Completion Date

Dec 20, 2022Actual

Completion Date

Dec 20, 2022Actual

First Submitted Date

Sep 27, 2022

First Submission Date that Met QC Criteria

Sep 27, 2022

First Posted Date

Sep 30, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2023

Last Update Posted Date

Jun 15, 2023Actual

Name	Class
Audeering GMBH	INDUSTRY
Biogen	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with relapsing MS			Other: Voice analysis
Healthy controls			Other: Voice analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Voice analysis	Other	Voice analysis	Healthy controls Patients with relapsing MS

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Patients with relapsing MS and healthy controls

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Helly Hammer	Inselspital, University Hospital Bern	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Inselspital University Hospital Bern		Bern		3010	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis
D005221	Fatigue
D003863	Depression

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided