Prevalence and Characteristics of Restless Leg Syndrome in Thai Patients With Parkinson's Disease

NCT06684782 | Recruiting

• 1 other identifier: 762/2567(IRB1)
• Study Type: observational
• Target: 310
• Locations: 1 country
• Sites: 2

Brief Summary

Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by pathologic intraneuronal alpha-synuclein-positive Lewy bodies and neuronal cell loss. The cardinal clinical symptoms and signs of PD are bradykinesia, rigidity, tremor, postural instability, and freezing attacks. The prevalence of PD increases with age, affecting 1-2% of the population over the age of 65 years, and 3% of those over 85 years. Restless legs syndrome (RLS) represents disturbing symptoms in lower limbs that lead to the urge to move, occurring in rest periods. Movements can partially or completely relieve these abnormal feelings. In 2014, the International RLS Study Group (IRLSSG) established five mandatory criteria for the diagnosis of RLS. Several studies supported that RLS and PD may share pathophysiological mechanisms.

Conditions

Restless Legs Syndrome

Keywords

restless leg syndrome; parkinson's disease; prevalence; Thai population

Outcome Measures

Primary Outcomes (1)

• The prevalence of restless leg syndrome in patients with Parkinson's disease

  At the time of recruitment

Secondary Outcomes (1)

• Clinical characteristics of Parkinson's disease patients with restless leg syndrome

  At the time of recruitment

Study Arms (1)

Patients with parkinson's disease

Other: Screening for symptoms of restless leg syndrome

Interventions

Screening for symptoms of restless leg syndrome OTHER

The patients will be screened for restless leg syndrome by clinical questioning.

Patients with parkinson's disease

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Parkinson's disease aged from 18 to 80 years who met the UK Parkinson's Disease Society Brain Bank Diagnostic Criteria. The patients must regularly visit the movement disorders clinic at least 2 times per year.

You may qualify if:

• Patients with Parkinson's disease aged from 18 to 80 years who met the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Diagnostic criteria.

You may not qualify if:

• Patients with atypical or secondary parkinsonism.
• Patients with Mini-mental status exam (MMSE) less than 24 of 30.
• Patients with secondary causes of restless leg syndrome including end-stage renal disease, iron deficiency anemia and pregnancy.

Sponsors & Collaborators

• Siriraj Hospital: lead

Study Sites (2)

Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

RECRUITING

Siriraj Hospital, Mahidol University

Bangkok, Thailand, 10310, Thailand

RECRUITING

MeSH Terms

Conditions

Restless Legs Syndrome; Parkinson Disease

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Jindapa Srikajon, Doctor of Medicine

  Siriraj Sleep Center, Faculty of Medicine, Siriraj Hospital, Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jindapa Srikajon, Doctor of Medicine

CONTACT

+66875932929; jindapas@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD.

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: November 12, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

TH (2)