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Dexmedetomidine on Basal Ganglia Neuronal Activity in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02982512
Recruitment Status : Unknown
Verified May 2018 by Clinica Universidad de Navarra, Universidad de Navarra.
Recruitment status was:  Recruiting
First Posted : December 5, 2016
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra

Brief 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.


Condition or disease Intervention/treatment Phase
Dexmedetomidine Deep Brain Stimulation Parkinson Disease Drug: Dexmedetomidine Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Different Concentrations of Dexmedetomidine on Basal Ganglia Neuronal Activity (Local Field Potentials) in Parkinson's Disease
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control recording
Recording of local field potentials without drugs from the deep brain stimulator
Experimental: Dexmedetomodine recording
Recording of local field potentials at different dexmedetomidine concentrations from the deep brain stimulator
Drug: Dexmedetomidine
Administration of dexmedetomidine a different concetrations
Other Name: Dexdor




Primary Outcome Measures :
  1. Beta activity (15-35 Hz) [ Time Frame: Control and dexmedetomidine exposure (around 300 min of continuous recording) ]
    Global power in the beta band (15-35 Hz) of the electrical oscillatory activity from deep brain structures.


Secondary Outcome Measures :
  1. Bispectral index scales (a single dimensionless number ranges from 0 - 100) [ Time Frame: Control and dexmedetomidine exposure (around 300 min of continuous recording) ]
    Weighted sum of several electroencephalographic subparameters, including a time domain, frequency domain, and high order spectral subparameters



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing placement of DBS for PD in two phases.
  • The patient must be of legal age (> 17 years old).
  • The patient or his representative has consented to participate in the study.
  • The patient should, in the investigator's opinion, be able to cooperate during the procedure.

Exclusion Criteria:

  • Known liver disease.
  • Pregnant or nursing women.
  • History of hypersensitivity to dexmedetomidine.
  • Heart block (2nd or 3rd degree), without pacemaker.
  • Symptomatic hypotension.
  • Severe stroke or other neurological deficits that may impair adequate cooperation or observation of the study endpoints.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02982512


Contacts
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Contact: Martinez-Simon Antonio, MD, PhD +34 948255400 ext 4813 amartinezs@unav.es
Contact: Fernandez Javier +34 948255400 ext 2723 jjfernandez@unav.es

Locations
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Spain
Clínica Universidad de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Contact: Fernandez J Javier    948255400 ext 4717    jjfernanderz@unav.es   
Contact: Martinez-Simon Antonio, MD, PhD    948255400 ext 4813    amartinezs@unav.es   
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Investigators
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Principal Investigator: Martinez-Simon Antonio, MD, PhD Staff of Anesthesiology Department
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Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT02982512    
Other Study ID Numbers: DEXPAR
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
Potential local fields
Subthalamic neuronal activity
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action