NCT04405479

Brief Summary

Early diagnosis is a key factor for effective treatment of multiple sclerosis. Accelerometer and gyroscope measurement of tremor could screen potential motor control dysfunction and predict a risk for development of multiple sclerosis.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

3.5 years

First QC Date

May 20, 2020

Last Update Submit

February 5, 2024

Conditions

Keywords

TremorAccelerometer

Outcome Measures

Primary Outcomes (1)

  • Tremor

    accelerometer (1 m·s-2)

    baseline

Secondary Outcomes (3)

  • Hand grip strength

    baseline

  • Hand and arm function

    baseline

  • Psychomotor processing speed

    baseline

Study Arms (2)

Patients with multiple sclerosis

MS patients will be chosen by an independent neurologist.

Behavioral: Examination of tremor and upper hand functions

Healthy volunteers

Healthy controls will be paired by age and sex with MS patients.

Behavioral: Examination of tremor and upper hand functions

Interventions

Participants will be only examined. They will not undergo any intervention.

Healthy volunteersPatients with multiple sclerosis

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

People with MS and healthy volunteers

You may qualify if:

  • Group 1:
  • Definite diagnosis of MS
  • prevailed motor deficit of upper extremities, but without visible tremor
  • stable clinical status in the preceding 3 months
  • Expanded Disability Status Scale score (EDSS) ≥ 2 ≤ 7.5, and
  • no corticosteroid therapy in the preceding month
  • Group 2:
  • Healthy volunteers in the age of 20-70 years will be employed
  • There will be defined as persons without any neurological disease diagnose at the time of the measurement.

You may not qualify if:

  • Patients with factors disturbing mobility (e.g. stroke, pregnancy, fractures) were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of neurology

Prague, 100 00, Czechia

RECRUITING

Kamila Řasová

Prague, 128 00, Czechia

RECRUITING

Deparment of revmatology and rehabilitation

Prague, 140 59, Czechia

RECRUITING

MeSH Terms

Conditions

Multiple SclerosisTremor

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kamila Řasová, Ph.D.

    Third Faculty of Mecicine, Charles Univerzity

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kamila Řasová, Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor PhDr. Kamila Řasová, Ph.D.

Study Record Dates

First Submitted

May 20, 2020

First Posted

May 28, 2020

Study Start

May 1, 2021

Primary Completion

October 28, 2024

Study Completion

December 30, 2024

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations