Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation

Parkinson's Disease Clinical Trial

Official title:

Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00608231
• Other study ID #: 070666
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: January 7, 2008
• Last updated: June 30, 2014
• Start date: January 2008
• Est. completion date: January 2012

Study information

• Verified date: June 2014
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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:

1. 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.

2. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dystonia
• Essential Tremor
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Dexmedetomidine Hydrochloride Infusion
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
• Normal Saline
Normal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Micro-electrode Recordings		Intra-operative	No
Secondary	Neurological Exam Findings		Intra-operative	No