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NCT04880356 | RECRUITING | Inherited Disease


Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
Sponsor:

I.R.C.C.S. Foundation Carlo Besta Neurological Institute

Brief Summary:

General aim of the study is the improvement of the clinical knowledge of ultra-rare inherited metabolic and degenerative neurological diseases (prevalence less than 5:100,000) in adulthood through the systematic longitudinal collection of clinical, laboratory and instrumental data.

Condition or disease

Inherited Disease

Rare Diseases

Metabolic Disease

Undiagnosed Disease

Neurologic Disorder

Neuro-Degenerative Disease

Intervention/treatment

collection of data

Detailed Description:

The study provides a collection of retrospective data from adult patients with ultra-rare inherited neurological diseases followed at "Carlo Besta" Neurological Institute from 1st January 2004 until March 2021. Further, prospective data will be collected starting from March 2021 (date of protocol approval) and spanning the next ten years. Normal clinical practice will be followed for collection of the prospective data. Follow-up assessment will be performed at least once a year to evaluate the disease course. Based on their clinical manifestations, patients will be assessed by using quantitative functional tests (clinimetric tests such as Timed Up and Go Test) and traditional ordinal scales (such as the scale for the assessment and rating of ataxia (SARA). Moreover, a varying of laboratory and instrumental tests (e.g., neuroimaging, neurophysiological investigations, etc.) will be used according to clinical practice in selected patients.

Study Type : OBSERVATIONAL
Estimated Enrollment : 100 participants
Official Title : Clinical, Instrumental and Laboratory Data Collection of Subjects with Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases
Actual Study Start Date : 2021-03-01
Estimated Primary Completion Date : 2031-03
Estimated Study Completion Date : 2031-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Age \>= 18 years
  • * Subjects with ultra-rare inherited degenerative and metabolic neurological diseases
  • * Subjects with undiagnosed neurological diseases (when supposed to be inherited)
Exclusion Criteria
  • * none

Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.

Location Details

NCT04880356


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How to Participate

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Locations


RECRUITING

Italy, Milano

IRCCS Carlo Besta Neurological Institute Foundation

Milan, Milano, Italy, 20133

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