Parkinson's Disease With Deep Brain Stimulation Clinical Trial
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.
| Status | Completed |
| Enrollment | 22 |
| Est. completion date | |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 21 Years and older |
| Eligibility |
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). |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Cincinnati | Cincinnati | Ohio |
| United States | University Hospitals of Case Western | Cleveland | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Great Lakes NeuroTechnologies Inc. | National Institute on Aging (NIA), University Hospital Case Medical Center, University of Cincinnati |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Effect of DBS cessation on motor function over time | Motor function evaluations (movement speed and magnitude) will be collected at various time points after DBS cessation. The effects over time will be examined. | 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. | No |