Kinesia 360 Parkinson's Monitoring Study

Great Lakes NeuroTechnologies

Status

Completed

Conditions

Parkinson's Disease

Treatments

Device: Kinesia 360

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT02657655

5R44AG044293-04 (U.S. NIH Grant/Contract)

5R44AG033947-05 (U.S. NIH Grant/Contract)

GLNT-K360-1

Pro000048239 (Other Identifier)

Details and patient eligibility

About

Kinesia 360 is an ambulatory symptom monitoring device for Parkinson's Disease (PD). The aim of this study is to investigate the impact, validation, and usability of the Kinesia 360 system.

Full description

This is a five-month study of 45 subjects (approximately 15 subjects per site), consisting of adult volunteers that have been clinically diagnosed with Parkinson's disease. Subjects will have a confirmed history of motor fluctuation with a variety of Parkinson's disease symptom severities. All subjects will user the Kinesia 360 system and complete motor diaries several times per month during the study period. Symptom reports will be provided to the treating clinical team. Motor function, quality of life, engagement, and satisfaction with care will be tracked throughout the study.

Enrollment

45 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Idiopathic Parkinson's Disease,
History of motor fluctuations (2 hrs/day of Off time and/or 1 hr/day of troublesome dyskinesia)
Fluent in English

Exclusion criteria

Inability to carry out study activities
Subjects with cognitive deficits that would prevent following instructions and serious medical conditions that would compromise a subject's safety
Subjects who have dementia, exhibited by Montreal Cognitive Assessment (MoCa) score of 22 or less.
Subjects who have had Deep Brain Stimulation (DBS) surgery less than 6 months prior to study enrollment, or who are deemed by the study investigator to be highly likely to undergo DBS surgery during the 6 month study period.