West Sweden Parkinson Objective Measurement Registry Study

Parkinson Disease Clinical Trial

— WestPORTS  

Official title:

West Sweden Parkinson Objective Measurement Registry Study - an Observational Cohort Study of the Prevalence and Development of Motor Symptoms Assessed With Automated Accelerometry in People With Parkinson's Disease in West Sweden

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03130595
• Other study ID #: WestPORTS
• Secondary ID: PARKreg
• Status: Active, not recruiting
• Start date: April 26, 2017
• Est. completion date: December 2030

Study information

• Verified date: May 2022
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

WestPORTS will recruit a randomly selected population consisting of 25% of all individuals with Parkinson's disease (ICD G209) that have visited any of the seven major outpatient neurology or geriatrics clinics in West Sweden (population 1.7M) during a predefined 12 month period between Sept 2016 and April 2018.

Baseline clinical and demographic data will be collected along with a 6 x 24h accelerometry recording using the Parkinson Kinetigraph (Global Kinetics). Repeated data collections will be made with regular intervals of up to 2 years as long as subjects are alive and willing.

Description:

The following data will be collected at baseline:

Date of birth Handedness Family history of Parkinson's disease Time of first motor symptom onset Laterality of symptom onset Time of diagnosis Time of first pharmacological intervention (if applicable) First antiparkinsonian drug

The following data will be collected at every visit/update Current living conditions Current non motor complications Current medications Hoehn and Yahr staging Clinical Impression of Severity Index in Parkinson's disease (CISI-PD)

Patient self assessments: PDQ8, NMS-Questionnaire, EQ5D-5L, Patient Reported Outcome in Parkinson's Disease (PRO-PD)

Parkinson Kinetigraph (PKG) accelerometry based recording of spontaneous movement patterns over a 6x24h period. The following indices will be extracted: median bradykinesia score (BKS), median dyskinesia score (DKS), Fluctuation Dyskinesia Score (FDS), Percent daytime with Immobility (PTI%), Percent daytime with tremor (PTT%).

The primary analysis will be descriptive and include demographic composition of the population, clinical characteristics and objective measurement data. In addition to indices a standardized qualitative assessment of PKG recordings will be made to identify motor fluctuations. Correlations between clinical ratings, patient reported outcomes, disease duration, age, medication and objective measurement indices will be studied

In the prospective phase of the study the development of objective movement recordings will be studied along with the development of clinical ratings and patient reported outcomes.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 320
• Est. completion date: December 2030
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Medical record with a G209 (Parkinson's disease) diagnosis

• A visit to one of the participating outpatient clinics in West Sweden within the last 6 months

• Informed consent

Exclusion Criteria:

• Diagnosis revised before visit.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinsonian Disorders
• Parkinsonism

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Göteborg

Sponsors (2)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden	Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective measurement of spontaneous movement patterns	Parkinson Kinetigraph	144 hours