Observational Study on Multiple Sclerosis

Fondazione Italiana Sclerosi Multipla

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Procedure: medical history, vital signs, ecocolor-Doppler; Procedure: neurological evaluation, ecocolor-Doppler; Procedure: neurological examination, Kurtzke EDSS, Barthel scale, ecocolor-Doppler

Study type: Observational

Funder types: Other

Identifiers

NCT04133779

FondazioneISM

Details and patient eligibility

About

This is a multicentre observational study which involves 43 of the major Italian centres that treat MS. The duration expected for the study participation of each subject was exclusively the necessary one for the screening visit and execution of the ecocolor-Doppler test, which could have also been executed on the same day.

Enrollment: 1,767 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Group A (MS)

  • Age 18-55 years;
  • Unisex patients diagnosed with MS according to McDonald criteria and successive relapse (38, 39), and subjects with CIS;
  • Course of the disease: RR-SP-PP-CIS;
  • Disease duration (starting from diagnosis): from 1 month to 25 years for subjects with RR, SP, and PP; a maximum of 5 years for subjects with CIS;
  • Not in clinical relapse (at least 30 days after the last clinical relapse);
  • Subjects treated or non-treated with immunomodulatory and immunosuppressive drugs;
  • Signature of the informed consent.

Group B (HC)

• Age 18-55 years;
• Absence of significant diseases and lack of familiarity with MS, ie health check-ups (HC);
• Signature of the informed consent.

The subjects included in this group could be, for example, unrelated relatives or spouses of those affected by MS or other diseases in the study or linked to these by affinity restrictions (such as, the father-in-law with the son-in-law, the husband with his wife's brother, etc.) or accompanying persons or operators of other centres.

Group C (OND)

• Aged 18-55 years;
• Subjects with other non-inflammatory neurodegenerative disease (OND), for example Parkinson, ALS, ataxy.

Group D (ONDi)

• Age 18-55 years;
• subjects suffering of other inflammatory neurodegenerative diseases (ONDi), for example optical neuromielitys, ADEM, encephalitis, neuro lupus, neurological complications of systemic autoimmune diseases;
• Signature of the informed consent.

Exclusion criteria

• • The presence of acute or chronic disease which are disabling or interfere with the design and objective of the study;

  • Clinically proven cardiopathy (NYHA ≥ I class);
  • Previous episodes of venal thromboembolism (including either deep venal thrombosis or pulmonary embolism);
  • Neoplasms;
  • Thrombophilia from an anamnestic definition;
  • Diabetes;
  • Primary or secondary pulmonary hypertension and in treatment for it;
  • Concurrent systemic steroid treatments or in the last 30 days;
  • Cerebrovascular diseases current or previous;
  • Episodes of global transitory amnesia;
  • Pregnancy.

Trial design

1,767 participants in 4 patient groups

Group A (MS)

Description:

* Age 18-55 years; * Unisex patients diagnosed with MS according to McDonald criteria and successive relapse (38, 39), and subjects with CIS; * Course of the disease: RR-SP-PP-CIS; * Disease duration (starting from diagnosis): from 1 month to 25 years for subjects with RR, SP, and PP; a maximum of 5 years for subjects with CIS; * Not in clinical relapse (at least 30 days after the last clinical relapse); * Subjects treated or non-treated with immunomodulatory and immunosupressive drugs; * Signature of the informed consent.

Treatment:

Procedure: neurological examination, Kurtzke EDSS, Barthel scale, ecocolor-Doppler

Group B (HC)

Description:

* Age 18-55 years; * Absence of significant diseases and lack of familiarity with MS, ie health check-ups (HC); * Signature of the informed consent. The subjects included in this group could be, for example, unrelated relatives or spouses of those affected by MS or other diseases in the study, or linked to these by affinity restrictions (such as, the father-in-law with the son-in-law, the husband with his wife's brother, etc.) or accompanying persons or operators of other centres.

Treatment:

Procedure: medical history, vital signs, ecocolor-Doppler

Group C (OND)

Description:

* Aged 18-55 years; * Subjects with other non-inflammatory neurodegenerative disease (OND), for example Parkinson, ALS, ataxy. * Signature of the informed consent.

Treatment:

Procedure: neurological evaluation, ecocolor-Doppler

Group D (ONDi)

Description:

* Age 18-55 years; * subjects suffering of other inflammatory neurodegenerative diseases (ONDi), for example optical neuromielitys, ADEM, encephalitis, neuro lupus, neurological complications of systemic autoimmune diseases; * Signature of the informed consent.

Treatment:

Procedure: neurological evaluation, ecocolor-Doppler