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OpenTrials
Completed

NCT Number: NCT03073239

Amyotrophic Lateral Sclerosis: a New Paradigm

Amyotrophic Lateral Sclerosis (ALS) is a degenerative neuromuscular disease, progressing inexorably to respiratory failure, the by involvement of respiratory muscles, the commitment with most impact on the prognosis of ALS.

According to current knowledge, the clinical presentation of the disease is characterized by spinal or bulbar involvement, the latter being associated with a worse prognosis.

There are multiple factors described in the aetiology of ALS, as the successive damage the motor neuron, which can happen in high-impact athletes, or exposure to heavy metals. Genetic mutations are also described, being associated to a higher prevalence of ALS.

Data from retrospective studies with ALS populations reveal a prevalence of 4-8 cases per 100,000 persons. Research carried out in Trás-os-Montes e Alto Douro region (Northeast of Portugal) shows a high prevalence of ALS, with near 10 cases per 100,000 persons, with a recent increase in the bulbar involvement. The reasons for the high prevalence of ALS in this region are unknown.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Hospitalar Tras-os-Montes e Alto Douro

Vila Real, 5000, Portugal

About this study

The objective of this research is to pursue potentially involved genetic mutations in this disease (new or previously described), in addition to carry out a epidemiological questionnaire including data on personal history, environmental and occupational exposure that might be underlying this high prevalence.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients with Amyotrophic Lateral Sclerosis sent to a medical consultation

Exclusion criteria

  • Amyotrophic Lateral Sclerosis not confirmed
  • Ages less than 18 years old

Treatment and study plan

ALS patients genetic characterization

Genetic

Genetic findings in ALS patients

ALS patients epidemiological caracterization

Other

Epidemiological characterization in ALS patients

Primary outcomes

  1. Finding environmental risk factor

    Time frame: 2 years

    Apply epidemiogycal form to All ALS patients sentido to respiratory evaluation in 2 years.

Secondary outcomes

  1. Regional prevalence

    Time frame: 1 year

    Identify All cases ALS in regional area ( in north of Portugal)

  2. Finding a genetic marker

    Time frame: 2 years

    Scan all ALS patients to eventually finding new ALS genes

Sponsors and collaborators

Lead sponsor

Conde, Bebiana, M.D.

Indiv

Registry information

Acronym: ALSParadigm

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 8, 2017
Registry last updated
Jul 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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