Clinical Trials Logo

Clinical Trial Summary

The implantation of a deep brain stimulator (DBS) is an established option to improve the symptoms of Parkinson's disease (PD) in patients that do not respond adequately to medical therapy. Most centers perform this surgery using a technique that involves microelectrode recording (MER) of neuronal activity for localization of the target nucleus, microstimulation of identified targets, and neurological intraoperative testing in a cooperative patient.

Dexmedetomidine, a α2-adrenergic receptors agonist, is a potent anxiolytic that acts at subcortical areas of the brain without involving GABA receptors. It provides excellent sedation without respiratory depression; also, it has an analgesic component and a predictable hemodynamic response. Low maintenance doses do not appear to interfere with MER. The possible effect of dexmedetomidine in the PD symptoms is still unclear.


Clinical Trial Description

The implantation of a deep brain stimulator (DBS) is an established option to improve the symptoms of Parkinson's disease (PD) in patients that do not respond adequately to medical therapy. Most centers perform this surgery using a technique that involves microelectrode recording (MER) of neuronal activity for localization of the target nucleus, microstimulation of identified targets, and neurological intraoperative testing in a cooperative patient. This surgery is usually performed in two stages. In the first stage, and under conscious sedation (CS), the target nucleus is localized and the DBS is implanted. About 5 days later, and under general anaesthesia, a programmable pulse generator is implanted and connected to the DBS.

The anesthetic approach varies depending on the institution, ranging from local anesthesia only with monitored care, conscious sedation, and the "asleep-awake" or "asleep-awake-asleep" technique. But sedative drugs can affect the quality of MER by suppressing the firing rate of basal ganglia structures, and alter PD symptoms. Propofol is the drug most commonly used. Its real influence on the quality of MER and PD symptoms is still today controversial. In recent years, some studies have suggested using dexmedetomidine as the main sedative agent for this intervention. Dexmedetomidine, a α2-adrenergic receptors agonist, is a potent anxiolytic that acts at subcortical areas of the brain without involving GABA receptors. It provides excellent sedation without respiratory depression; also, it has an analgesic component and a predictable hemodynamic response. Low maintenance doses do not appear to interfere with MER. The possible effect of dexmedetomidine in the PD symptoms is still unclear. All these characteristics make it a good choice for sedation of PD patients undergoing DBS surgery.

Studying the influence of anesthetic drugs on basal ganglia activity and PD motor symptoms in humans and in a clinical setting is complicated. First, it is difficult to establish a control group to compare effects in different nuclei. There is some data concerning clinical outcomes (clinical symptoms or long term stimulation parameters) but without electrophysiological data. MERs data has been compared between different patients or in the same patient but between contralateral targets. Few studies analyze electrophysiological data with or without one sedative drug in the same target. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02982512
Study type Interventional
Source Clinica Universidad de Navarra, Universidad de Navarra
Contact Martinez-Simon Antonio, MD, PhD
Phone +34 948255400
Email amartinezs@unav.es
Status Recruiting
Phase Phase 4
Start date May 1, 2017
Completion date December 2018

See also
  Status Clinical Trial Phase
Completed NCT05415774 - Combined Deep Brain Stimulation in Parkinson's Disease N/A
Recruiting NCT04691661 - Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease Phase 2
Active, not recruiting NCT05754086 - A Multidimensional Study on Articulation Deficits in Parkinsons Disease
Completed NCT04045925 - Feasibility Study of the Taïso Practice in Parkinson's Disease N/A
Recruiting NCT04194762 - PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation N/A
Completed NCT02705755 - TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH) Phase 2
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT05830253 - Free-living Monitoring of Parkinson's Disease Using Smart Objects
Recruiting NCT03272230 - Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System N/A
Recruiting NCT06139965 - Validity and Reliability of the Turkish Version of the Comprehensive Coordination Scale in Parkinson's Patients
Completed NCT04580849 - Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease N/A
Completed NCT03980418 - Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam N/A
Completed NCT04477161 - Effect of Ketone Esters in Parkinson's Disease N/A
Completed NCT04942392 - Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic N/A
Terminated NCT03446833 - LFP Beta aDBS Feasibility Study N/A
Completed NCT03497884 - Individualized Precise Localization of rTMS on Primary Motor Area N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Recruiting NCT04997642 - Parkinson's Disease and Movement Disorders Clinical Database
Completed NCT04117737 - A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson N/A
Recruiting NCT03618901 - Rock Steady Boxing vs. Sensory Attention Focused Exercise N/A