Resting Postural Tremor in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04405479
• Other study ID #: EK-VP/23/0/2014
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: Charles University, Czech Republic
• Contact: Kamila Rasová, Ph.D.
• Phone: +420604511416
• Email: kamila.rasova[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2024
• Est. primary completion date: October 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis
• Tremor

Intervention

Behavioral:
• Examination of tremor and upper hand functions
Participants will be only examined. They will not undergo any intervention.

Locations

Country	Name	City	State
Czechia	Deparment of revmatology and rehabilitation	Prague
Czechia	Department of neurology	Prague
Czechia	Kamila Rasová	Praha

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tremor	accelerometer (1 m·s-2)	baseline
Secondary	Hand grip strength	Hand dynamometer JAMA	baseline
Secondary	Hand and arm function	Nine Hole Peg Test	baseline
Secondary	Psychomotor processing speed	Coin Rotation Task	baseline