BradyXplore Phase II: Bradykinesia Feature Extraction System

NCT02358876 | Completed Results

• 1 other identifier: 5R44NS065554
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; Deep brain stimulation; Bradykinesia

Outcome Measures

Primary Outcomes (1)

• Percentage of Kinesia One Assessments Performed

  Percentage of Kinesia One assessments performed as directed

  Two weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with implanted deep brain stimulation systems for treating Parkinson's disease

You may qualify if:

• 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.

You may not qualify if:

• Dementia (MoCA \< 25)

Sponsors & Collaborators

• Great Lakes NeuroTechnologies Inc.: lead
• University of Cincinnati: collaborator
• The Cleveland Clinic: collaborator

Study Sites (2)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Hypokinesia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Biomedical Research Manager
• Organization: Great Lakes NeuroTechnologies Inc

dheldman@glneurotech.com

2163615410

Study Officials

• Dustin A Heldman, PhD

  Great Lakes NeuroTechnologies

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: February 9, 2015
• Study Start: February 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 6, 2016
• Results First Posted: October 6, 2016

Record last verified: 2016-08

Locations

US (2)