drugset / Trial / NCT03283150

Deep Brain Stimulation (DBS) Sedation

NCT03283150 ↗

Phase 4 Terminated 20 enrolled University of Wisconsin, Madison
Non-randomizedSequentialOpen-labelTreatment

Summary

Deep brain stimulation (DBS) of different brain nuclei is a treatment for multiple brain disorders. The subthalamic nucleus (STN) and globus pallidus have been used to treat advanced Parkinson's disease for a long time. The ventral intermediate nucleus of the thalamus is an effective target for treating essential tremor patients. STN and the internal segment of the globus pallidus are useful targets for treating dystonia. To achieve this optimal electrode localization, many centers perform electrophysiological mapping of the target nuclei using microelectrode recording (MER). This way they can achieve precise localization of the electrode. During the mapping procedure, microelectrodes are passed through the target nuclei, and the electrical neuronal activity is observed and recorded. The surgical team can identify the precise location of the target nuclei and its borders according to the typical activity of its neurons. This study will compare the activity of neurons in several DBS targets before, during and after sedation with propofol, remifentanil and dexmedetomidine. The goal is to understand the effects of anesthetics on the neuronal activity in these targets, allowing us to choose the most appropriate sedation protocol to use during implantation of DBS electrodes in deep brain structures (bearing in mind that each structure may have a different optimal protocol).

Timeline

Start
2017-12-01
Primary completion
2022-01-20
Completion
2022-01-20

Outcome

Outcome not reported

Stopped: “Due to a decrease in scheduled study-eligible patients, we terminated the study prematurely”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexmedetomidine Other / unclassified — —
Comparator Propofol Small molecule — —
Comparator Remifentanil Small molecule — —

Indications

No indication recorded.