Parkinstep: Automated PD Gait and Balance Assessment for Optimizing DBS

Great Lakes NeuroTechnologies

Status: Completed

Conditions: Parkinson's Disease With Deep Brain Stimulation

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT02080572

2R44AG033947-03A1 (U.S. NIH Grant/Contract)

AG033947-03A1

Details and patient eligibility

About

Changes in deep brain stimulation (DBS) settings can have a delayed effect on gait function, which makes it impractical to optimize DBS for gait parameters in the clinic. Wearable movement sensors could be used to assess gait impairment in the patient's home hours after treatment adjustments are made in the clinic. This study aims to quantitatively evaluate the effects of turning off deep brain stimulation on lower extremity and gait function over three hours. This study will provide vital information about our patient worn system's ability to detect changes in lower impairment over time, which could be used to assist with DBS tuning for the lower extremities and gait in the future.

Enrollment: 22 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of idiopathic Parkinson's disease
• Age > 21
• Underwent DBS surgery targeting the subthalamic nucleus (STN)
• Bilateral or midline involvement when "off" DBS/medication state
• Clinical history of gait impairment or freezing of gait

Exclusion criteria

• "Parkinson's plus" syndrome, secondary, or atypical Parkinson's disease
• Underwent DBS surgery targeting the ventral intermediate (VIM)
• Unable to walk independent of a wheelchair (use of assistive devices, like a cane, is okay for this study)
• Dementia (determined by a neuropsychological assessment).

Trial design

22 participants in 1 patient group

Parkinson's Disease with DBS

Description:

Individuals with Parkinson's disease and deep brain stimulation will be recruited.