Identification of Clinically Relevant Markers of Deep Brain Stimulation

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Parkinson Disease

Clinical Trial Details

NCT number	NCT02794233
Study type	Interventional
Source	University of Florida
Contact
Status	Completed
Phase	N/A
Start date	July 2016
Completion date	June 2017

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Identification of Clinically Relevant Markers of Deep Brain Stimulation Electrode Impedance

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms