A Phase 4 interventional study of Dexmedetomidine in Parkinson's Disease and Deep Brain Stimulation Surgery, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-12-08.
Sponsored by University of Wisconsin, Madison · Phase 4, Interventional, and Treatment
The purpose of this research study is to find out whether dexmedetomidine changes brain cell activity in the subthalamic nucleus (STN).
In order to find whether dexmedetomidine is optimal for sedation during Deep brain stimulation surgery, we will measure the electrical activity in the STN during Deep brain stimulation surgery, and measure how this activity is changed during administration of Dexmedetomidine. We hypothesize that dexmedetomidine does not change the firing rate and pattern in the STN.
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This study's enrollment of 6 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
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The study is performed in patients undergoing DBS electrode implantation to their STN for the treatment of parkinson's disease. Microelectrode recording (MER) is performed as part of STN electrode implantation surgery, to increase the precision of the stimulating electrode placement. The study includes administration of dexmedetomidine while recording electrical activity at a single location to evaluate the effects of this drug on the MER.
Drug: Dexmedetomidine
Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved.
Also known as: Precedex
Change in Average Population Spiking Activity
We calculated the root mean square (RMS) of the high frequency electrical activity. This is a common measure for the spiking rate of the population of neurons in the vicinity of the electrode tip. This Measure has been previously described as a useful measure to determine the target location during deep brain stimulation (DBS) procedures. We calculated the change in RMS inside the STN between baseline and peak sedation. For each subject we normalized the RMS to the RMS of the electrical activity outside the nucleus. This is done to eliminate the effects of noise and variability in electrode resistance. Thus, the normalized RMS is a pure number with no units.
Time frame: 20-35 minutes following drug administration
Change in Average Firing Pattern in the STN
We've used total power in the Beta range (13-30Hz) to evaluate change in firing pattern and oscillation frequency.
Time frame: 20-35 minutes following drug administration
Time to Recovery
The time it takes for the patient to become alert after drug administration is stopped.
Time frame: 20-60 minutes after stopping drug administration
Portion of Participants With Timely Return of the Neuronal Activity to Baseline
The portion of patients in which neuronal activity returned to baseline within 30 after stopping sedation.
Time frame: 30 minutes after stopping drug administration
| Milestone | Dexmedetomidine During MER |
|---|---|
| Started | 6 |
| Completed | 5 |
| Not completed | 1 |
We calculated the root mean square (RMS) of the high frequency electrical activity. This is a common measure for the spiking rate of the population of neurons in the vicinity of the electrode tip. This Measure has been previously described as a useful measure to determine the target location during deep brain stimulation (DBS) procedures. We calculated the change in RMS inside the STN between baseline and peak sedation. For each subject we normalized the RMS to the RMS of the electrical activity outside the nucleus. This is done to eliminate the effects of noise and variability in electrode resistance. Thus, the normalized RMS is a pure number with no units.
| Percent change | Dexmedetomidine Modulation of MER |
|---|---|
| Change in Average Population Spiking Activity | 42.8 ± 12.7 |
We've used total power in the Beta range (13-30Hz) to evaluate change in firing pattern and oscillation frequency.
| percentage change | Dexmedetomidine During MER |
|---|---|
| Change in Average Firing Pattern in the STN | 39.9 ± 76.2 |
The time it takes for the patient to become alert after drug administration is stopped.
| minutes | Dexmedetomidine During MER |
|---|---|
| Time to Recovery | 16 ± 13 |
The portion of patients in which neuronal activity returned to baseline within 30 after stopping sedation.
| Participants | Dexmedetomidine During MER |
|---|---|
| Portion of Participants With Timely Return of the Neuronal Activity to Baseline | 2 |
Collected over Duration of procedure, 6-10 hours.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Continuous(years) | Dexmedetomidine During MER |
|---|---|
| Mean | 61.5 (53 to 71) |
| Sex: Female, Male(Participants) | Dexmedetomidine During MER |
|---|---|
| Female | 4 |
| Male | 2 |
| Region of Enrollment(Participants) | Dexmedetomidine During MER |
|---|---|
| United States | 6 |
Plan to share: No
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University of Wisconsin, Madison