Parkinstep: Automated PD Gait and Balance Assessment for Optimizing DBS

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02080572

Enrollment

Registered

2014-03-06

Start date

2014-02-28

Completion date

Unknown

Last updated

2015-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease With Deep Brain Stimulation

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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).

Design outcomes

Primary

Measure	Time frame	Description
Effect of DBS cessation on motor function over time	All data will be collected within a single session not to exceed 4 hours. All data will be analyzed within one month of study completion.	Motor function evaluations (movement speed and magnitude) will be collected at various time points after DBS cessation. The effects over time will be examined.

Countries

United States

Outcome results