Parkinson Disease
Conditions
Keywords
Deep Brain Stimulation, Electric Impedance, Parkinson disease
Brief summary
The study will look into the changes of Deep Brain Stimulation (DBS) measured impedances in patients of Parkinson disease (PD) as a function of their functional state (lying, sitting and walking) and dopaminergic medication intake (levodopa or dopamine agonists). The goal is to use DBS measured impedance as a surrogate of the functional and medication states of PD patients.
Detailed description
Subjects will be recruited from the population of patients who are already implanted with DBS for treatment of PD. At the patient's follow up visit they will be asked to come to the clinic in the off medication state. Off medication is defined as at least 8 hours since the last medication dosing. Data will be collected during three phases: OFF state, transitioning state, and ON state. Subjects will be asked to assume different functional states (lying, sitting or walking) for 1 minute each. During these functional states, multiple measures of impedance will be collected. * OFF state data collection: The subject will be examined to assess his motor examination score using the UPDRS-III. Measurements of impedance will be collected multiple times in the lying down and sitting up states. * Transition state data collection: The subject will be asked to take their dopamine medication. The medication will take approximately 1 hour to take full effect. Measurements of impedance will be collected every 10 minutes during this transition from the OFF state to the ON state. Patients will be asked to report at what point they felt the ON: state (they can report the state as OFF, unsure, transition or ON). * ON state data collection: The ON state examination will start after 1 hour from medication administration. Subjects will be examined using the UPDRS-III. Measurements of impedance will be collected in the lying down, sitting and walking states. Summary of the study protocol: OFF state Transition state ON' state UPDRS-III x x Impedance Lying down x x Sitting up x x x Walking x UPDRS I and II x Hoehn and Yahr x x
Interventions
OTHERImpedance measurements
Refer to study description
Sponsors
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Idiopathic Parkinson's patients with DBS (unilateral or bilateral) * Must be taking dopamine agonist or levodopa regimen * Medtronic Neurostimulator Activa SC, PC or PC+S (IPG)
Exclusion criteria
* Hoehn and Yahr (H&Y) 4 and above * History of DBS revision or lead replacement surgery * Current or prior non-Medtronic Activa SC, PC or PC+S IPG * Historical information of more than 1 hour delay to ON state as average
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in impedance value as it relates to the functional state. | 1 hour (for both outcomes) | Functional state is defined as either: lying, sitting or walking. |
| Change in impedance value as it relates to the dopaminergic medication state. | 1 hour (for both outcomes) | Dopaminergic medications are defined as either levodopa containing or dopamine agonist containing medications. The state is defined as the OFF state (medication effect is not present) and ON state (medication effect noted). |
Countries
United States
Outcome results
None listed