Deep Brain Stimulation Surgery, Parkinson's Disease
Conditions
Keywords
SubThalamic Nucleus, Microelectrode recording, Deep Brain Stimulation Electrode implantation
Brief summary
The purpose of this research study is to find out whether dexmedetomidine changes brain cell activity in the subthalamic nucleus (STN).
Detailed description
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.
Interventions
DRUGDexmedetomidine
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.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled to undergo bilateral STN electrode implantation surgery with Micro-electrode recording for the treatment of Parkinson's disease.
Exclusion criteria
* Hypersensitivity to dexmedetomidine * Bradycardia: Sinus rhythm slower than 50 bpm * Known or suspected obstructive sleep apnea * Suspected difficult intubation * Pregnancy * Under 18 years of age or over 85 years of age * Cognitive disability impairing understanding the experiment or signing the informed consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Average Population Spiking Activity | 20-35 minutes following drug administration | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Average Firing Pattern in the STN | 20-35 minutes following drug administration | We've used total power in the Beta range (13-30Hz) to evaluate change in firing pattern and oscillation frequency. |
| Time to Recovery | 20-60 minutes after stopping drug administration | The time it takes for the patient to become alert after drug administration is stopped. |
| Portion of Participants With Timely Return of the Neuronal Activity to Baseline | 30 minutes after stopping drug administration | The portion of patients in which neuronal activity returned to baseline within 30 after stopping sedation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexmedetomidine During MER Administration of dexmedetomidine during the Microelectrode recording part of STN electrode implantation surgery.
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. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Dexmedetomidine During MER |
|---|---|
| Age, Continuous | 61.5 years |
| Region of Enrollment United States | 6 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
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
Population: All participants had the normalized RMS of the electrical activity calculated during control period, and under maximal sedation, and the difference between the two was calculated and normalized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine Modulation of MER | Change in Average Population Spiking Activity | 42.8 Percent change | Standard Deviation 12.7 |
Secondary
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
Population: All participants that received sedation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine Modulation of MER | Change in Average Firing Pattern in the STN | 39.9 percentage change | Standard Error 76.2 |
Secondary
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
Population: All participants that received sedation. As the activity did not return to baseline within the allocated time for the study (30 minutes), we report the portion of patients in which the activity returned to baseline within this time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexmedetomidine Modulation of MER | Portion of Participants With Timely Return of the Neuronal Activity to Baseline | 2 Participants |
Secondary
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
Population: All participants that received sedation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine Modulation of MER | Time to Recovery | 16 minutes | Standard Deviation 13 |