Resting Postural Tremor in Multiple Sclerosis

NCT ID: NCT04405479

Last Updated: 2024-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2024-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with multiple sclerosis

MS patients will be chosen by an independent neurologist.

Examination of tremor and upper hand functions

Intervention Type BEHAVIORAL

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.

Examination of tremor and upper hand functions

Intervention Type BEHAVIORAL

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

Interventions

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Examination of tremor and upper hand functions

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

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

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Kamila Řasová

associate professor PhDr. Kamila Řasová, Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kamila Řasová, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Third Faculty of Mecicine, Charles Univerzity

Locations

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Department of neurology

Prague, , Czechia

Site Status RECRUITING

Kamila Řasová

Prague, , Czechia

Site Status RECRUITING

Deparment of revmatology and rehabilitation

Prague, , Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Kamila Řasová, Ph.D.

Role: CONTACT

+420604511416

Facility Contacts

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Ivana Stetkarova, prof MD PhD

Role: primary

+420197170

Kamila Řasová, Ph.D.

Role: primary

+420604511416

Natalia Hrušková

Role: backup

+420702836959

Tom Philipp, M.D., Ph.D.

Role: primary

+420737273589

Other Identifiers

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EK-VP/23/0/2014

Identifier Type: -

Identifier Source: org_study_id

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