Parkinson's disease MedDRA version: 16.1 Level: LLT Classification code 10013113 Term: Disease Parkinson's System Organ Class: 100000004852
Conditions
Sponsors
Clínica Universidad de Navarra/Universidad de Navarra
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients must meet all the following inclusion criteria: 1. Ability to provide informed consent and express their desire to satisfy all requirements of the protocol during the study period. 2. The patient should, in the investigator's opinion, be able to meet all the requirements of the clinical trial. 3. The patient must be an adult (more than 18 years old). 4. The patient will undergo placement of a deep brain stimulator for Parkinson's disease in subthalamic nucleus or globus pallidus under sedation, by indication of the responsible physician. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: Patients with any of the following exclusion criteria will not be included in the clinical trial: 1. Hypersensitivity to dexmedetomidine or propofol. 2. Heart block type 2nd or 3rd degree without pacemaker. 3. Symptomatic hypotension. 4. Patient with severe stroke. 5. Pregnant or lactating patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Study whether there are changes (and their characteristics) in local field potentials recordings in deep subcortical structures, obtained through the stimulators implanted to treat Parkinson's disease, with the administration of dexmedetomidine and propofol.;Secondary Objective: Make a comparative analysis of possible changes in the patient´ score of the UPDRS-III scale at ?off? situation, with dexmedetomidine and different estimated plasma levels of propofol.;Primary end point(s): Registration signal potency of deep brain activity at different frequencies through the stimulator (microvolts?m-2).;Timepoint(s) of evaluation of this end point: In "baseline" situation without anesthetic medication (day 4), with dexmedetomidine (day 1) and after different concentrations of propofol (day 6). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Demographic data (gender, age, weight). ? Parkinson disease type, duration and regular medication. ? Score of the UPDRS-III scale at "off" and "on" situation. ? Stimulation target nucleus. Subthalamic nucleus or globus pallidus. ? Changes in the score UPDRS-III scale with the administration of dexmedetomidine and propofol. ? Adverse events observed during the study.;Timepoint(s) of evaluation of this end point: At different moments during the study | — |
Countries
Spain
Contacts
Public ContactUCICEC
Clinica Universidad de Navarra
Outcome results
None listed