Effects of Dexmedetomidine on Activity in the Subthalamic Nucleus

NCT01721460 | Completed Phase 4 Results DMC

• 1 other identifier: 2012-0400
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to find out whether dexmedetomidine changes brain cell activity in the subthalamic nucleus (STN).

Conditions

Parkinson's Disease; Deep Brain Stimulation Surgery

Keywords

SubThalamic Nucleus; Microelectrode recording; Deep Brain Stimulation Electrode implantation

Outcome Measures

Primary Outcomes (1)

• Change in Average Population Spiking Activity

  We calculated the root mean square (RMS) of the high frequency electrical activity. This is a common measure for the spiking rate of the population of neurons in the vicinity of the electrode tip. This Measure has been previously described as a useful measure to determine the target location during deep brain stimulation (DBS) procedures. We calculated the change in RMS inside the STN between baseline and peak sedation. For each subject we normalized the RMS to the RMS of the electrical activity outside the nucleus. This is done to eliminate the effects of noise and variability in electrode resistance. Thus, the normalized RMS is a pure number with no units.

  20-35 minutes following drug administration

Secondary Outcomes (3)

• Change in Average Firing Pattern in the STN

  20-35 minutes following drug administration

• Time to Recovery

  20-60 minutes after stopping drug administration

• Portion of Participants With Timely Return of the Neuronal Activity to Baseline

  30 minutes after stopping drug administration

Study Arms (1)

Dexmedetomidine during MER

EXPERIMENTAL

The study is performed in patients undergoing DBS electrode implantation to their STN for the treatment of parkinson's disease. Microelectrode recording (MER) is performed as part of STN electrode implantation surgery, to increase the precision of the stimulating electrode placement. The study includes administration of dexmedetomidine while recording electrical activity at a single location to evaluate the effects of this drug on the MER.

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved.

Also known as: Precedex

Dexmedetomidine during MER

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to undergo bilateral STN electrode implantation surgery with Micro-electrode recording for the treatment of Parkinson's disease.

You may not qualify if:

• Hypersensitivity to dexmedetomidine
• Bradycardia: Sinus rhythm slower than 50 bpm
• Known or suspected obstructive sleep apnea
• Suspected difficult intubation
• Pregnancy
• Under 18 years of age or over 85 years of age
• Cognitive disability impairing understanding the experiment or signing the informed consent form

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin - Madison, School of Medicine and Public Health

Madison, Wisconsin, 53705, United States

Location

Related Publications (1)

• Amlong C, Rusy D, Sanders RD, Lake W, Raz A. Dexmedetomidine depresses neuronal activity in the subthalamic nucleus during deep brain stimulation electrode implantation surgery. BJA Open. 2022 Sep 9;3:100088. doi: 10.1016/j.bjao.2022.100088. eCollection 2022 Sep.

  PMID: 37588575 DERIVED

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

Results Point of Contact

• Title: Dr. Aeyal Raz
• Organization: University od Wisconsin - Madison

raz@wisc.edu

608-263-8100

Study Officials

• Aeyal Raz, MD, PhD

  University of Wisconsin, Madison, Department of anesthesiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2012
• First Posted: November 5, 2012
• Study Start: November 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 8, 2017
• Results First Posted: November 6, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)