Use in clinical trials

Existing outcome measures used for clinical trials in Parkinson’s are based on subjective patient reported inputs, such as, cumbersome point-in-time rating scales (UPDRS, AIMS) and/or patient diaries which are often inaccurate due to reliance on patient recollection and poor compliance.

The PKG™ system is a clinically validated system for objective, ambulatory and continuous assessment of movement disorder symptoms in Parkinson’s disease and can be considered as a measure in clinical studies.

PKG feature Benefits in clinical studies
PKG is an objective assessment system
  • Delivers statistically reliable and reproducible data without the inter and intra-rater variability seen in traditional rating scales
  • Objective quantification of the kinematics of bradykinesia and dyskinesia aids in determining whether a subject is “on” or “off” and the correlation with the time of medication administration and/or consumption
  • Supports evidence based therapeutic intervention submissions for regulatory authorities and payors with objective data measures and analysis
PKG is easy to use for the clinic and requires minimal involvement by the patient
  • Allows for easy deployment by clinics as well as integration into clinical workflow and research protocols
  • Delivers high compliance with use of PKG by patients, providing complete data while reducing technical impediments to patient inclusion
Ability to collect objective motor symptom data during activities of daily living in the patient’s home
  • In home assessment delivers ‘real world’ symptom and medication response data which is free of ‘consultation room’ artefacts
  • The PKG assessment process can be initiated and managed remotely thereby reducing both clinic consultation time and travel burden for subjects participating in a clinical studies
PKG meets validation and regulatory requirements
  • The PKG is validated against currently used symptom rating scales such as UPDRS-III (movement scale) and modified AIMS
  • FDA cleared, CE marked, TGA registered makes the PKG suitable for global, multicentre clinical studies
Comprehensive and robust data delivery
  • Movement data is easily available from the PKG to support regulatory and reimbursement submissions
  • PKG metrics data can be presented in a format which is highly conducive to population analysis for patient stratification, triaging or study recruitment purposes
  • Objective PD symptoms metrics can be presented in a single view – such as symptom severity, symptom fluctuations, degree of medication compliance, amount of somnolence/sleep, propensity for impulsive behaviours, extent of tremor etc.