N/A N=32

BradyXplore Phase II: Bradykinesia Feature Extraction System

Parkinson's Disease

Bottom Line

View on ClinicalTrials.gov: NCT02358876 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2016

Primary outcome: Primary: Percentage of Kinesia One Assessments Performed — 99 percentage of home assessments completed

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Great Lakes NeuroTechnologies Inc.
Primary completion: Jul 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Kinesia One Assessments Performed	99	—

Summary

Study objectives are to improve motion sensor algorithms for measuring bradykinesia in the clinic and the home, evaluate test-retest reliability of motion sensor algorithms for measuring bradykinesia compared to clinician raters, determine if participant-perceived symptom severities correlate with motion sensor measures, determine if speed, amplitude, and rhythm fluctuate differentially throughout the day in individuals with implanted deep brain stimulation systems, receive feedback on the usability of Kinesia One, and evaluate Kinesia One compliance in the home.

Eligibility Criteria

Inclusion Criteria

Diagnosis of idiopathic Parkinson's disease
Has Deep Brain Stimulation Implant for Parkinson's disease
Historical bradykinesia rating of 2 or greater on at least one of the Unified Parkinson's Disease Rating Scale (UPDRS) finger-tapping, hand-movements, and pronation-supination tasks with DBS off.

Exclusion Criteria

Dementia (MoCA < 25)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02358876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.