Trial record 1 of 461 for:    Amyotrophic Lateral Sclerosis (ALS)
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Amyotrophic Lateral Sclerosis: a New Paradigm (ALSParadigm)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03073239
Recruitment Status : Recruiting
First Posted : March 8, 2017
Last Update Posted : March 8, 2017
Information provided by (Responsible Party):
Conde, Bebiana, M.D.

Brief Summary:

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.

Condition or disease Intervention/treatment
Amyotrophic Lateral Sclerosis Other: study ALS patients

Detailed Description:
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.

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Amyotrophic Lateral Sclerosis: a New Paradigm
Actual Study Start Date : December 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Group/Cohort Intervention/treatment
ALS patients
ALS patients group sent for respiratory evaluation
Other: study ALS patients
Characterization of epidemiological features and genetic.

Primary Outcome Measures :
  1. Finding environmental risk factor [ Time Frame: 2 years ]
    Apply epidemiogycal form to All ALS patients sentido to respiratory evaluation in 2 years.

Secondary Outcome Measures :
  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

Biospecimen Retention:   Samples With DNA
blood to test als mutations

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Amyotrophic Lateral Sclerosis sent to a medical consultation

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03073239

Contact: Bebiana Conde, MD 00351936305294
Contact: Bebiana Conde, MD 00351259300500 ext 5291

Centro Hospitalar Tras-os-Montes e Alto Douro Recruiting
Vila Real, Portugal, 5000
Contact: Bebiana Conde, MD    00351936305294   
Contact: Bebiana Conde, MD    00351259300500 ext 5291   
Sponsors and Collaborators
Conde, Bebiana, M.D.
Principal Investigator: Bebiana Conde, MD Centro Hospitalar Tras-os-Montes e Alto Douro

Responsible Party: Conde, Bebiana, M.D. Identifier: NCT03073239     History of Changes
Other Study ID Numbers: 2
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: March 8, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Research results will be shared with the scientific community through the publication of 2 to 3 papers in medical journals, as well as through the participation in national and international conferences. Whenever requested by the participants, the individual data resulting from clinical examinations will be provided.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Conde, Bebiana, M.D.:
Amyotrophic Lateral Sclerosis
Bulbar disfunction
Rik factors ALS

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases