Amyotrophic Lateral Sclerosis Registry in Thailand

Recruiting

• Conditions: ALS (Amyotrophic Lateral Sclerosis)

• Registration Number: NCT07175935
• Lead Sponsor: Chulalongkorn University

Brief Summary

This is a prospective, observational, multicenter registry designed to collect comprehensive clinical, genetic, and outcome data from patients diagnosed with amyotrophic lateral sclerosis (ALS) across Thailand. The registry will establish a national dataset to describe epidemiology, clinical presentation, progression, and treatment outcomes, and will serve as a platform for future clinical and translational research.

Detailed Description

Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disorder that affects upper and lower motor neurons, leading to progressive muscle weakness, disability, and respiratory failure. Despite increasing research worldwide, Thailand lacks large-scale systematic data on ALS epidemiology, clinical characteristics, genetic profiles, and outcomes.

This registry will prospectively enroll ALS patients from major academic hospitals and specialized neuromuscular centers nationwide. Patients will be followed longitudinally using standardized assessments, including ALSFRS-R, staging systems (King, MiTos, 9-point), motor and respiratory function, quality-of-life measures, and cognitive/behavioral evaluations.

Data will be collected through a REDCap electronic database, ensuring confidentiality and compliance with Thai PDPA and international data protection standards. No experimental interventions will be performed; patients will receive standard of care treatments as determined by their treating physicians.

Study Timeline

• Study Start: 2025-03-01
• Study First Submitted: 2025-08-27
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-14
• Last Update Submitted: 2025-09-14
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Diagnosis of ALS according to El Escorial or Gold Coast criteria
• Age ≥ 18 years
• Ability and willingness to provide informed consent

Exclusion Criteria

• Patients unwilling to provide informed consent
• Patients with alternative diagnoses mimicking ALS

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	10 years	Time Frame: From enrollment until death from any cause (assessed continuously, with updates at each follow-up).; Outcome: Overall survival in ALS patients across Thailand, with survival curves stratified by demographic, clinical, and genetic factors.

Secondary Outcome Measures

Name	Time	Method
ALS Functional Decline	10 years	Measure: Change in ALS Functional Rating Scale-Revised (ALSFRS-R) score.; Time Frame: Every 6-12 months.; Outcome: Rate of functional decline, expressed as points lost per month/year.
Disease Staging Progression	10 years	Measure: King's and MiToS staging systems, 9-point staging.; Time Frame: Every 6-12 months.; Outcome: Proportion of patients progressing to higher stages; median time to stage transitions.
Respiratory Outcomes	10 years	Measure: Forced vital capacity (FVC % predicted).; Time Frame: Every 6-12 months.; Outcome: Decline in FVC
Changes in health-related quality of life over time.	10 years	Measure: EQ-5D-5L.; Time Frame: Annually.; Outcome: Changes in health-related quality of life over time.
Cognitive and Behavioral Profile	10 years	Measure: Edinburgh Cognitive and Behavioral ALS Screen (ECAS); Time Frame: Annually.; Outcome: Frequency and pattern of cognitive/behavioral impairment in ALS patients.
Healthcare Utilization and Treatment Patterns	10 years	Measure: Use of riluzole, edaravone, non-invasive ventilation, gastrostomy, and multidisciplinary ALS clinic care.; Time Frame: Throughout follow-up.; Outcome: Patterns of treatment access and their association with survival and quality of life.
Genetic and Environmental Risk Associations	10 years	Measure: Frequency of ALS-associated genetic variants (e.g., SOD1, C9orf72, TARDBP, FUS) and correlation with clinical phenotype and progression.; Time Frame: As available.; Outcome: Genotype-phenotype correlation; association with disease onset, progression, and survival.

Trial Locations

Locations (1)

King Chulalongkorn Memorial hospital, The Thai Red Cross Society; 🇹🇭 Pathum Wan, Bangkok, Thailand