Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation

NCT00608231 | Withdrawn Phase 2 DMC

• 1 other identifier: 070666
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson's Disease; Essential Tremor; Dystonia

Outcome Measures

Primary Outcomes (1)

• Micro-electrode Recordings

  Intra-operative

Secondary Outcomes (1)

• Neurological Exam Findings

  Intra-operative

Study Arms (8)

PD-STN

EXPERIMENTAL

Parkinson's Disease -- STN target

Drug: Dexmedetomidine Hydrochloride Infusion

PD - GPi

EXPERIMENTAL

Parkinson's Disease -- GPi target

Drug: Dexmedetomidine Hydrochloride Infusion

ET - VIM

EXPERIMENTAL

Essential Tremor -- VIM target

Drug: Dexmedetomidine Hydrochloride Infusion

Dystonia - GPi

EXPERIMENTAL

Dystonia -- GPi target

Drug: Dexmedetomidine Hydrochloride Infusion

PD - STN Control

PLACEBO COMPARATOR

Parkinson's Disease -- STN target

Drug: Normal Saline

PD - GPi Control

PLACEBO COMPARATOR

Parkinson's Disease -- GPi target

Drug: Normal Saline

ET - VIM Control

PLACEBO COMPARATOR

Essential Tremor -- VIM target

Drug: Normal Saline

Dystonia - GPi Control

PLACEBO COMPARATOR

Dystonia -- GPi target

Drug: Normal Saline

Interventions

Dexmedetomidine Hydrochloride Infusion DRUG

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

Also known as: Precedex

Dystonia - GPi; ET - VIM; PD - GPi; PD-STN

Normal Saline DRUG

Normal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery

Also known as: Placebo control

Dystonia - GPi Control; ET - VIM Control; PD - GPi Control; PD - STN Control

Eligibility Criteria

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

You may qualify if:

• Any patient who has agreed to undergo DBS implantation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Essential Tremor; Dystonia

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Joseph Neimat, M.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: February 6, 2008
• Study Start: January 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: July 1, 2014

Record last verified: 2014-06

Locations

US (1)