Resting Postural Tremor in Multiple Sclerosis

Sponsor
Charles University, Czech Republic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04405479
Collaborator
(none)
30
3
20
10
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Examination of tremor and upper hand functions

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 Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Spectral Analyses of Resting Postural Tremor Measured by Accelerometer and Gyroscope as a Predictive Tool of Multiple Sclerosis
Actual Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Oct 28, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Tremor [baseline]

    accelerometer (1 m·s-2)

Secondary Outcome Measures

  1. Hand grip strength [baseline]

    Hand dynamometer JAMA

  2. Hand and arm function [baseline]

    Nine Hole Peg Test

  3. Psychomotor processing speed [baseline]

    Coin Rotation Task

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of neurology Prague Czechia 100 00
2 Deparment of revmatology and rehabilitation Prague Czechia 140 59
3 Kamila Řasová Praha Czechia 128 00

Sponsors and Collaborators

  • Charles University, Czech Republic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kamila Řasová, associate professor PhDr. Kamila Řasová, Ph.D., Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT04405479
Other Study ID Numbers:
  • EK-VP/23/0/2014
First Posted:
May 28, 2020
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kamila Řasová, associate professor PhDr. Kamila Řasová, Ph.D., Charles University, Czech Republic
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022