Dexmedetomidine on Basal Ganglia Neuronal Activity in Parkinson's Disease

NCT02982512 | Unknown Phase 4 DMC

• 1 other identifier: DEXPAR
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Dexmedetomidine; Deep Brain Stimulation; Parkinson Disease

Keywords

Potential local fields; Subthalamic neuronal activity

Outcome Measures

Primary Outcomes (1)

• Beta activity (15-35 Hz)

  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 Outcomes (1)

• Bispectral index scales (a single dimensionless number ranges from 0 - 100)

  Control and dexmedetomidine exposure (around 300 min of continuous recording)

Study Arms (2)

Control recording

NO INTERVENTION

Recording of local field potentials without drugs from the deep brain stimulator

Dexmedetomodine recording

EXPERIMENTAL

Recording of local field potentials at different dexmedetomidine concentrations from the deep brain stimulator

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Administration of dexmedetomidine a different concetrations

Also known as: Dexdor

Dexmedetomodine recording

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Martinez-Simon Antonio, MD, PhD

  Staff of Anesthesiology Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martinez-Simon Antonio, MD, PhD

CONTACT

+34 948255400; amartinezs@unav.es

Fernandez Javier

CONTACT

+34 948255400; jjfernandez@unav.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: December 5, 2016
• Study Start: May 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

ES (1)