Dexmedetomidine on Basal Ganglia Neuronal Activity in Parkinson's Disease

Effects of Different Concentrations of Dexmedetomidine on Basal Ganglia Neuronal Activity (Local Field Potentials) in Parkinson's Disease

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.

Study Overview

Status

Unknown

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Martinez-Simon Antonio, MD, PhD
  • Phone Number: 4813 +34 948255400
  • Email: amartinezs@unav.es

Study Contact Backup

Study Locations

    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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
Administration of dexmedetomidine a different concetrations
Other Names:
  • Dexdor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Control and dexmedetomidine exposure (around 300 min of continuous recording)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Control and dexmedetomidine exposure (around 300 min of continuous recording)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Martinez-Simon Antonio, MD, PhD, Staff of Anesthesiology Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2017

Primary Completion (ANTICIPATED)

September 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

November 28, 2016

First Submitted That Met QC Criteria

November 30, 2016

First Posted (ESTIMATE)

December 5, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 4, 2018

Last Verified

May 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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