## Protocol Section
### Identification Module
**NCT ID:** NCT04240379

**Acronym:** METACOGSEP

**Brief Title:** Metacognition Assessment in Patient With Multiple Sclerosis

**Official Title:** Metacognition Assessment in Patient With Multiple Sclerosis

#### Organization Study ID Info
**ID:** 38RC19.146
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Grenoble
#### Secondary ID Infos
**Domain:** ID RCB
**ID:** 2019-A01278-49
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2022-04-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-06-01

**Type:** ACTUAL

**Last Update Submit Date:** 2022-05-31

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-04-08

**Type:** ACTUAL

#### Start Date
**Date:** 2020-06-11

**Type:** ACTUAL

**Status Verified Date:** 2022-05

#### Study First Post Date
**Date:** 2020-01-27
**Type:** ACTUAL
**Study First Submit Date:** 2020-01-06
**Study First Submit QC Date:** 2020-01-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University Grenoble Alps

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Grenoble

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study will assessed the level of consciousness of MS patients suffering of cognitive and motor disorders. Understanding the awareness of the disease is crucial to allow better management of these patients. It has been shown, for other neurological pathologies, that a lack of awareness of deficits leads to inefficient rehabilitation and a disorder of understanding the impact of deficits in daily activities. Metacognition could be altered with age, so we will include participants between 18 and 60 years old.

**Detailed Description:** Subject who have to do neurological assessement by the Multiple sclerosis Functional Composite (MSFC) will be enrolled.

The patient will estimate the time to undergo the test. This time will be compared to the time really make by the patient to realise test.

### Conditions Module

**Conditions:**

- Multiple Sclerosis

**Keywords:**

- Multiple Sclerosis

- Multiple Sclerosis Functional Composite (MSFC)

- Metacognition

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 80

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Metacognitive precision based on Multiple Sclerosis Functional Composite (MSFC) score

**Measure:** Metacognitive precision

**Time Frame:** Day 1

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Diagnosis of multiple sclerosis
* Voluntary for participate to study

Exclusion Criteria:

* Neurological disease other than Multiple Sclerosis
* psychiatric disease, other than depressiveness
* illicit substance abuse
* Persons referred to in Articles L1121-5 to 8 of the French Public Health Code

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

**Study Population:** This study will be proposed to subject :

* Male or female with diagnosis of MS,
* admitted in neurological unit for passing the MSFC (Multiple Sclerosis Functionnal Composite) test
* who respect selection criteria.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Grenoble

**Country:** France

**Facility:** Chu Grenoble Alpes

**Zip:** 38043

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Calabrese P. Neuropsychology of multiple sclerosis--an overview. J Neurol. 2006 Feb;253 Suppl 1:I10-5. doi: 10.1007/s00415-006-1103-1.

**PMID:** 16477479

**Citation:** Chiaravalloti ND, DeLuca J. Cognitive impairment in multiple sclerosis. Lancet Neurol. 2008 Dec;7(12):1139-51. doi: 10.1016/S1474-4422(08)70259-X.

**PMID:** 19007738

**Citation:** Beatty WW, Monson N. Metamemory in multiple sclerosis. J Clin Exp Neuropsychol. 1991 Mar;13(2):309-27. doi: 10.1080/01688639108401046.

**PMID:** 1688342

## 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

### 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: 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

### Condition Browse Module - Meshes

- ID: D000009103

- Term: Multiple Sclerosis

- ID: D000012598

- Term: Sclerosis

### Misc Info Module

- Version Holder: 2024-05-24
