Multiple SclerosisNCT04405479
Resting Postural Tremor in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Charles University, Czech Republic at 3 sites in Czechia.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Examination of tremor and upper hand functions
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 3 sitesCzechia
- Study dates
- 1 May 2021to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People with MS and healthy volunteers
Who may be able to join
- 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
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- 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.
Who cannot join
- Patients with factors disturbing mobility (e.g. stroke, pregnancy, fractures) were excluded from the study.
Trial locations and contacts
3 sites in 1 country.
Czechia3 sites, 3 recruiting
- Recruiting
Department of neurology
Prague, 100 00
Ivana Stetkarova, prof MD PhD, +420197170, ivana.stetkarova@fnkv.cz
- Recruiting
Kamila Řasová
Prague, 128 00
Kamila Řasová, Ph.D., +420604511416, kamila.rasova@gmail.com
Natalia Hrušková, +420702836959, natalia0087@gmail.com
- Recruiting
Deparment of revmatology and rehabilitation
Prague, 140 59
Tom Philipp, M.D., Ph.D., +420737273589, tom.philipp@ftn.cz
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Examination of tremor and upper hand functions
- Keywords
- Tremor, Accelerometer
- Medical subject headings
- Multiple Sclerosis, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Examination of tremor and upper hand functionsBehavioural
Participants will be only examined. They will not undergo any intervention.
| Study group | Role | What they receive |
|---|---|---|
| Patients with multiple sclerosis | MS patients will be chosen by an independent neurologist. Receives: Behavioral: Examination of tremor and upper hand functions | |
| Healthy volunteers | Healthy controls will be paired by age and sex with MS patients. Receives: Behavioral: Examination of tremor and upper hand functions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tremor
accelerometer (1 m·s-2)
Measured: baseline
Secondary outcomes (3)
Hand grip strength
Hand dynamometer JAMA
Measured: baseline
Hand and arm function
Nine Hole Peg Test
Measured: baseline
Psychomotor processing speed
Coin Rotation Task
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start1 May 2021
- Primary completion28 Oct 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamila Řasová, Charles University, Czech Republic
- Investigators
- Kamila Řasová, Ph.D., Principal investigator, Third Faculty of Mecicine, Charles Univerzity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405479
- Sponsor's protocol ID
- EK-VP/23/0/2014
- Status last verified
- Feb 2024
- First submitted
- 20 May 2020
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectral Analyses of Resting Postural Tremor Measured by Accelerometer and Gyroscope as a Predictive Tool of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04405479
- Acronym / sponsor ID
- EK-VP/23/0/2014
- Conditions
- Multiple Sclerosis
- Keywords
- Tremor, Accelerometer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 28 Oct 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with multiple sclerosis | – | Behavioral: Examination of tremor and upper hand functionsMS patients will be chosen by an independent neurologist. |
| Healthy volunteers | – | Behavioral: Examination of tremor and upper hand functionsHealthy controls will be paired by age and sex with MS patients. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People with MS and healthy volunteers
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with factors disturbing mobility (e.g. stroke, pregnancy, fractures) were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Examination of tremor and upper hand functionsParticipants will be only examined. They will not undergo any intervention. | Behavioural | Healthy volunteers, Patients with multiple sclerosis |
Primary outcome
Tremor
Time frame: baseline
accelerometer (1 m·s-2)
3 secondary outcomes
Hand grip strength
Time frame: baseline
Hand and arm function
Time frame: baseline
Psychomotor processing speed
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamila Řasová, Ph.D. principal investigator
Third Faculty of Mecicine, Charles Univerzity
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Charles University, Czech Republic at 3 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kamila Řasová, Ph.D. (+420604511416, kamila.rasova@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tremor (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.