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Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation

Primary Purpose

Parkinson's Disease, Essential Tremor, Dystonia

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine Hydrochloride Infusion
Normal Saline
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any patient who has agreed to undergo DBS implantation.

Exclusion Criteria:

  • Patients who fail recommendation for DBS surgery discussed in Vanderbilt University Movement Disorder Clinical Conference.
  • Patients not consented for DBS surgery.
  • Patients or legal guardians not able to provide informed consent.

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Placebo Comparator

Placebo Comparator

Arm Label

PD-STN

PD - GPi

ET - VIM

Dystonia - GPi

PD - STN Control

PD - GPi Control

ET - VIM Control

Dystonia - GPi Control

Arm Description

Parkinson's Disease -- STN target

Parkinson's Disease -- GPi target

Essential Tremor -- VIM target

Dystonia -- GPi target

Parkinson's Disease -- STN target

Parkinson's Disease -- GPi target

Essential Tremor -- VIM target

Dystonia -- GPi target

Outcomes

Primary Outcome Measures

Micro-electrode Recordings

Secondary Outcome Measures

Neurological Exam Findings

Full Information

First Posted
January 7, 2008
Last Updated
June 30, 2014
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT00608231
Brief Title
Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation
Official Title
Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Intraoperative recording could not be maintained for required period
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To test the hypothesis that sedation induced by Dexmedetomidine at levels appropriate for awake, DBS surgery has no significant effect on electrophysiological parameters of DBS micro-electrode recordings
Detailed Description
Deep brain stimulator (DBS) implants are used in the treatment of medically refractory movement disorders such as Parkinson's disease, essential tremor and dystonia. Because of the uniqueness of each individual brain, the surgery to implant a DBS electrode requires detailed anatomic and physiological information for each patient. The anatomic data is obtained before surgery via a Magnetic Resonance Imaging (MRI) scan of the patient's brain. Physiological data is obtained during the operation via micro-electrode recording of the patient's brain and neurological examination of the patient. Therefore, DBS surgery can be uncomfortable to patients, as it can be very time consuming and requires the patient to be awake and attentive. The specific aims of this project are: To test the hypothesis that sedation induced by Dexmedetomidine at levels appropriate for awake, DBS surgery has no significant effect on electrophysiological parameters of DBS micro-electrode recordings. To test the hypothesis that sedation induced by Dexmedetomidine at levels appropriate for awake, DBS surgery have no significant effects on neurological findings and/or patient cooperation during neurological examination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Essential Tremor, Dystonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PD-STN
Arm Type
Experimental
Arm Description
Parkinson's Disease -- STN target
Arm Title
PD - GPi
Arm Type
Experimental
Arm Description
Parkinson's Disease -- GPi target
Arm Title
ET - VIM
Arm Type
Experimental
Arm Description
Essential Tremor -- VIM target
Arm Title
Dystonia - GPi
Arm Type
Experimental
Arm Description
Dystonia -- GPi target
Arm Title
PD - STN Control
Arm Type
Placebo Comparator
Arm Description
Parkinson's Disease -- STN target
Arm Title
PD - GPi Control
Arm Type
Placebo Comparator
Arm Description
Parkinson's Disease -- GPi target
Arm Title
ET - VIM Control
Arm Type
Placebo Comparator
Arm Description
Essential Tremor -- VIM target
Arm Title
Dystonia - GPi Control
Arm Type
Placebo Comparator
Arm Description
Dystonia -- GPi target
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine Hydrochloride Infusion
Other Intervention Name(s)
Precedex
Intervention Description
Dexmedetomidine Hydrochloride Infusion(0.5-1.0 mg/kg)intravenous over 10 minutes with dose adjustment for goal Richmond Agitation and Sedation Scale of -1 During deep brain stimulator implantation surgery
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
Placebo control
Intervention Description
Normal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery
Primary Outcome Measure Information:
Title
Micro-electrode Recordings
Time Frame
Intra-operative
Secondary Outcome Measure Information:
Title
Neurological Exam Findings
Time Frame
Intra-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any patient who has agreed to undergo DBS implantation. Exclusion Criteria: Patients who fail recommendation for DBS surgery discussed in Vanderbilt University Movement Disorder Clinical Conference. Patients not consented for DBS surgery. Patients or legal guardians not able to provide informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Neimat, M.D.
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

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Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation

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