- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04405479
Resting Postural Tremor in Multiple Sclerosis
Spectral Analyses of Resting Postural Tremor Measured by Accelerometer and Gyroscope as a Predictive Tool of Multiple Sclerosis
Study Overview
Status
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Kamila Řasová, Ph.D.
- Phone Number: +420604511416
- Email: kamila.rasova@gmail.com
Study Locations
-
-
-
Prague, Czechia, 100 00
- Recruiting
- Department of Neurology
-
Contact:
- Ivana Stetkarova, prof MD PhD
- Phone Number: +420197170
- Email: ivana.stetkarova@fnkv.cz
-
Prague, Czechia, 140 59
- Recruiting
- Deparment of revmatology and rehabilitation
-
Contact:
- Tom Philipp, M.D., Ph.D.
- Phone Number: +420737273589
- Email: tom.philipp@ftn.cz
-
Praha, Czechia, 128 00
- Recruiting
- Kamila Řasová
-
Contact:
- Kamila Řasová, Ph.D.
- Phone Number: +420604511416
- Email: kamila.rasova@gmail.com
-
Contact:
- Natalia Hrušková
- Phone Number: +420702836959
- Email: natalia0087@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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.
|
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.
|
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
Investigators
- Principal Investigator: Kamila Řasová, Ph.D., Third Faculty of Mecicine, Charles Univerzity
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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-
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-
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-
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-
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