## Protocol Section
### Identification Module
**NCT ID:** NCT04405479

**Brief Title:** Resting Postural Tremor in Multiple Sclerosis

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

#### Organization Study ID Info
**ID:** EK-VP/23/0/2014
#### Organization
**Class:** OTHER
**Full Name:** Charles University, Czech Republic
### Status Module
#### Completion Date
**Date:** 2024-12-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-06

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-05

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-10-28

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-05-01

**Type:** ACTUAL

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2020-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2020-05-20
**Study First Submit QC Date:** 2020-05-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Charles University, Czech Republic

#### Responsible Party

**Investigator Affiliation:** Charles University, Czech Republic

**Investigator Full Name:** Kamila Řasová

**Investigator Title:** associate professor PhDr. Kamila Řasová, Ph.D.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

**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 Module

**Conditions:**

- Multiple Sclerosis

**Keywords:**

- Tremor

- Accelerometer

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** MS patients will be chosen by an independent neurologist.

**Intervention Names:**

- Behavioral: Examination of tremor and upper hand functions

**Label:** Patients with multiple sclerosis

#### Arm Group 2

**Description:** Healthy controls will be paired by age and sex with MS patients.

**Intervention Names:**

- Behavioral: Examination of tremor and upper hand functions

**Label:** Healthy volunteers

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Healthy volunteers

- Patients with multiple sclerosis

**Description:** Participants will be only examined. They will not undergo any intervention.

**Name:** Examination of tremor and upper hand functions

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** accelerometer (1 m·s-2)

**Measure:** Tremor

**Time Frame:** baseline

#### Secondary Outcomes

**Description:** Hand dynamometer JAMA

**Measure:** Hand grip strength

**Time Frame:** baseline

**Description:** Nine Hole Peg Test

**Measure:** Hand and arm function

**Time Frame:** baseline

**Description:** Coin Rotation Task

**Measure:** Psychomotor processing speed

**Time Frame:** baseline

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 70 Years

**Minimum Age:** 20 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** People with MS and healthy volunteers

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** kamila.rasova@gmail.com

**Name:** Kamila Řasová, Ph.D.

**Phone:** +420604511416

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Prague

**Contacts:**

***Contact 1:***

- **Email:** ivana.stetkarova@fnkv.cz

- **Name:** Ivana Stetkarova, prof MD PhD

- **Phone:** +420197170

- **Role:** CONTACT

**Country:** Czechia

**Facility:** Department of neurology

**Status:** RECRUITING

**Zip:** 100 00

**Location 2:**

**City:** Prague

**Contacts:**

***Contact 1:***

- **Email:** tom.philipp@ftn.cz

- **Name:** Tom Philipp, M.D., Ph.D.

- **Phone:** +420737273589

- **Role:** CONTACT

**Country:** Czechia

**Facility:** Deparment of revmatology and rehabilitation

**Status:** RECRUITING

**Zip:** 140 59

**Location 3:**

**City:** Praha

**Contacts:**

***Contact 1:***

- **Email:** kamila.rasova@gmail.com

- **Name:** Kamila Řasová, Ph.D.

- **Phone:** +420604511416

- **Role:** CONTACT

***Contact 2:***

- **Email:** natalia0087@gmail.com

- **Name:** Natalia Hrušková

- **Phone:** +420702836959

- **Role:** CONTACT

**Country:** Czechia

**Facility:** Kamila Řasová

**Status:** RECRUITING

**Zip:** 128 00

#### Overall Officials

**Official 1:**

**Affiliation:** Third Faculty of Mecicine, Charles Univerzity

**Name:** Kamila Řasová, Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000020278

- Term: Demyelinating Autoimmune Diseases, CNS

- ID: D000020274

- Term: Autoimmune Diseases of the Nervous System

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000003711

- Term: Demyelinating Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

- ID: D000020820

- Term: Dyskinesias

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M12060

- Name: Multiple Sclerosis

- Relevance: HIGH

- As Found: Multiple Sclerosis

- ID: M15415

- Name: Sclerosis

- Relevance: HIGH

- As Found: Sclerosis

- ID: M16956

- Name: Tremor

- Relevance: HIGH

- As Found: Tremor

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22098

- Name: Demyelinating Autoimmune Diseases, CNS

- Relevance: LOW

- As Found: Unknown

- ID: M22094

- Name: Autoimmune Diseases of the Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: M6909

- Name: Demyelinating Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22574

- Name: Dyskinesias

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009103

- Term: Multiple Sclerosis

- ID: D000014202

- Term: Tremor

- ID: D000012598

- Term: Sclerosis

### Misc Info Module

- Version Holder: 2024-05-24
