Identification of Clinically Relevant Markers of Deep Brain Stimulation Electrode Impedance
| Status: | Completed |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 25 - 80 |
| Updated: | 5/17/2018 |
| Start Date: | July 2016 |
| End Date: | June 2017 |
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.
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.
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
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
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
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