Resting Postural Tremor in Multiple Sclerosis

February 5, 2024 updated by: Kamila Řasová, Charles University, Czech Republic

Spectral Analyses of Resting Postural Tremor Measured by Accelerometer and Gyroscope as a Predictive Tool of Multiple Sclerosis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to test whether specially developed accelerometer and gyroscope can differentiate pattern of resting postural tremor in healthy and people with multiple sclerosis.

Spectral analysis and the correlation of the average signal spectra will be computed. Moreover, categorization based on the tremor component according to the maximum likelihood estimation will be done.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
      • Prague, Czechia, 100 00
        • Recruiting
        • Department of Neurology
        • Contact:
      • Prague, Czechia, 140 59
        • Recruiting
        • Deparment of revmatology and rehabilitation
        • Contact:
      • Praha, Czechia, 128 00

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

People with MS and healthy volunteers

Description

Inclusion Criteria:

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.

Exclusion Criteria (both groups):

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with multiple sclerosis
MS patients will be chosen by an independent neurologist.
Behavioral: Examination of tremor and upper hand functions
Participants will be only examined. They will not undergo any intervention.
Healthy volunteers
Healthy controls will be paired by age and sex with MS patients.
Behavioral: Examination of tremor and upper hand functions
Participants will be only examined. They will not undergo any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tremor
Time Frame: baseline
accelerometer (1 m·s-2)
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hand grip strength
Time Frame: baseline
Hand dynamometer JAMA
baseline
Hand and arm function
Time Frame: baseline
Nine Hole Peg Test
baseline
Psychomotor processing speed
Time Frame: baseline
Coin Rotation Task
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Investigators

  • Principal Investigator: Kamila Řasová, Ph.D., Third Faculty of Mecicine, Charles Univerzity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Estimated)

October 28, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

May 20, 2020

First Submitted That Met QC Criteria

May 27, 2020

First Posted (Actual)

May 28, 2020

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK-VP/23/0/2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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