Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine during MER | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 20-35 minutes following drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 20-35 minutes following drug administration |
| Time to Recovery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Aeyal Raz, MD, PhD | University of Wisconsin, Madison, Department of anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin - Madison, School of Medicine and Public Health | Madison | Wisconsin | 53705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37588575 | Derived | Amlong C, Rusy D, Sanders RD, Lake W, Raz A. Dexmedetomidine depresses neuronal activity in the subthalamic nucleus during deep brain stimulation electrode implantation surgery. BJA Open. 2022 Sep 9;3:100088. doi: 10.1016/j.bjao.2022.100088. eCollection 2022 Sep. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dexmedetomidine During MER | Administration of dexmedetomidine during the Microelectrode recording (MER) part of subthalamic nucleus (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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | Percent change | 20-35 minutes following drug administration |
|
Duration of procedure, 6-10 hours.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aeyal Raz | University od Wisconsin - Madison | 608-263-8100 | raz@wisc.edu |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
The time it takes for the patient to become alert after drug administration is stopped.
| 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. | 30 minutes after stopping drug administration |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Dexmedetomidine Modulation of MER |
Change in RMS value between baseline (awake) and maximal sedation during dexmedetomidine administration. |
|
|
| 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. | All participants that received sedation | Posted | Mean | Standard Error | percentage change | 20-35 minutes following drug administration |
|
|
|
| Secondary | Time to Recovery | The time it takes for the patient to become alert after drug administration is stopped. | All participants that received sedation. | Posted | Mean | Standard Deviation | minutes | 20-60 minutes after stopping drug administration |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 30 minutes after stopping drug administration |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
Not provided
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |