Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation

Vanderbilt University

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Essential Tremor; Dystonia; Parkinson's Disease

Treatments: Drug: Dexmedetomidine Hydrochloride Infusion; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00608231

070666

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 8 patient groups, including a placebo group

PD-STN

Experimental group

Description:

Parkinson's Disease -- STN target

Treatment:

Drug: Dexmedetomidine Hydrochloride Infusion

PD - GPi

Experimental group

Description:

Parkinson's Disease -- GPi target

Treatment:

Drug: Dexmedetomidine Hydrochloride Infusion

ET - VIM

Experimental group

Description:

Essential Tremor -- VIM target

Treatment:

Drug: Dexmedetomidine Hydrochloride Infusion

Dystonia - GPi

Experimental group

Description:

Dystonia -- GPi target

Treatment:

Drug: Dexmedetomidine Hydrochloride Infusion

PD - STN Control

Placebo Comparator group

Description:

Parkinson's Disease -- STN target

Treatment:

Drug: Normal Saline

PD - GPi Control

Placebo Comparator group

Description:

Parkinson's Disease -- GPi target

Treatment:

Drug: Normal Saline

ET - VIM Control

Placebo Comparator group

Description:

Essential Tremor -- VIM target

Treatment:

Drug: Normal Saline

Dystonia - GPi Control

Placebo Comparator group

Description:

Dystonia -- GPi target

Treatment:

Drug: Normal Saline