Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation

Phase 2

Withdrawn

• Conditions: Dystonia; Parkinson's Disease; Essential Tremor
• Interventions: Drug: Dexmedetomidine Hydrochloride Infusion; Drug: Normal Saline

• Registration Number: NCT00608231
• Lead Sponsor: Vanderbilt University

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:

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-07
• Study First Submitted QC: 2008-01-25
• Study First Posted: 2008-02-06
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-30
• Last Update Posted: 2014-07-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ET - VIM	Dexmedetomidine Hydrochloride Infusion	Essential Tremor -- VIM target
Dystonia - GPi	Dexmedetomidine Hydrochloride Infusion	Dystonia -- GPi target
PD - STN Control	Normal Saline	Parkinson's Disease -- STN target
PD - GPi Control	Normal Saline	Parkinson's Disease -- GPi target
ET - VIM Control	Normal Saline	Essential Tremor -- VIM target
Dystonia - GPi Control	Normal Saline	Dystonia -- GPi target
PD-STN	Dexmedetomidine Hydrochloride Infusion	Parkinson's Disease -- STN target
PD - GPi	Dexmedetomidine Hydrochloride Infusion	Parkinson's Disease -- GPi target

Primary Outcome Measures

Name	Time	Method
Micro-electrode Recordings	Intra-operative

Secondary Outcome Measures

Name	Time	Method
Neurological Exam Findings	Intra-operative

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States