Investigation of the Epidemiological Factors Associated With the Development of Amyotrophic Lateral Sclerosis (ALS)

Recruiting

• Conditions: ALS
• Interventions: Other: Observation

• Registration Number: NCT03366506
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

Investigation of the epidemiological factors associated with amyotrophic lateral sclerosis (ALS) in Israel with a view to future international collaboration. Particularly addressing:-

1. Differences between ethnic subgroups

2. Differences between immigrant and native-born populations

3. Differences according to military service profile Clinical features gathered at each routine visit ,throughout the entire course of the disease, will be recorded in database format, in order to correlate with potential epidemiological factors.

Detailed Description

Investigation of the epidemiological factors associated with amyotrophic lateral sclerosis (ALS) in Israel with a view to future international collaboration. Particularly addressing:-

1. Differences between ethnic subgroups

2. Differences between immigrant and native-born populations

3. Differences according to military service profile Clinical features gathered at each routine visit ,throughout the entire course of the disease, will be recorded in database format, in order to correlate with potential epidemiological factors.

The clinical features will include pattern of onset, details of full clinical exam ( including ALSFRS-R score, power, reflexes, and other signs of upper or lower-motor neuron dysfunction.

Correlations between different clinical parameters themselves will be made, as well as correlation between clinical parameters and other epidemiological factors.

Study Timeline

• Study Start: 2009-03-09
• Study First Submitted: 2017-12-04
• Study First Submitted QC: 2017-12-04
• Study First Posted: 2017-12-08
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10
• Primary Completion: 2049-03
• Study Completion: 2050-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Suspected, possible, probable ,definite ALS

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ALS patients	Observation	ALS patients ( suspected, possible, probable or definite per El-Escorial criteria). Observation

Primary Outcome Measures

Name	Time	Method
Progression rate	up to 10 years	Progression of ALSFRS-R score over time

Secondary Outcome Measures

Name	Time	Method
Appearance of clinical features of UMN or LMN dysfunction	10 years	Appearance of clinical features of UMN or LMN dysfunction over time

Trial Locations

Locations (1)

Hadassah Medical Organisation; 🇮🇱 Jerusalem, Israel