Sedation During Microelectrode Recordings Before Deep Brain Stimulation for Movement Disorders. - Full Text View

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00355927

Purpose

The purpose of this study is to detect possible changes in the electrical activity of the Basal Ganglia related to sedation during deep brain stimulation surgery.

Condition	Intervention
Movement Disorders Parkinson Disease Parkinsonian Disorders Dystonia Tourette Syndrome	Procedure: Sedation with IV propofol

Genetics Home Reference related topics: early-onset primary dystonia familial encephalopathy with neuroserpin inclusion bodies familial paroxysmal nonkinesigenic dyskinesia Parkinson disease Tourette syndrome

MedlinePlus related topics: Dystonia Movement Disorders Parkinson's Disease Tourette Syndrome

Drug Information available for: Propofol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Changes of the Neuronal Activity in the Subthalamic Nucleus Under Propofol Sedation During Stereotactic Electrode Implantation.

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

Changes in the electrical activity of neuron cells of the basal ganglia in the examined patients [ Time Frame: Within 24 hours needed to analyse the data ]

Estimated Enrollment:	20
Study Start Date:	September 2006
Estimated Study Completion Date:	July 2008

Intervention Details:

Propofol(50 microgram/kg/min.), I.V. for 5-10 minutes, Until a level of light sedation is achieved

Detailed Description:

Deep Brain Stimulation is commonly used for the treatment of movement disorders. Electrode positioning is usually performed under local anesthesia in fully awake patients. The procedure is uncomfortable to the patients who have to remain motionless during the whole surgery. Previous reports of electrode positioning under general anesthesia was found to be less accurate. This result was probably due to the effect of the anesthetics on the electrical activity of the Basal Ganglia.

The purpose of this study is to detect possible changes in the electrical activity of the Basal Ganglia related to propofol sedation. Electrical activity of single neurons will be recorded before and after sedation.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Candidate for Deep Brain Stimulation Surgery.
Informed concent obtained.

Exclusion Criteria:

Suspected difficult intubation (by history or physical examination).
Allergy to Propofol, eggs or soy-beans.
History of sleep apnea syndrome.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355927

Locations

Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:	Dan Eimerl, MD	Hadassah Medical Organization
Principal Investigator:	Zvi Israel, MD	Hadassah Medical Organization

More Information

Publications:

Israel Z, Hassin-Baer S. Subthalamic stimulation for Parkinson's disease. Isr Med Assoc J. 2005 Jul;7(7):458-63. Review.

Maltete D, Navarro S, Welter ML, Roche S, Bonnet AM, Houeto JL, Mesnage V, Pidoux B, Dormont D, Cornu P, Agid Y. Subthalamic stimulation in Parkinson disease: with or without anesthesia? Arch Neurol. 2004 Mar;61(3):390-2.

Limousin P, Krack P, Pollak P, Benazzouz A, Ardouin C, Hoffmann D, Benabid AL. Electrical stimulation of the subthalamic nucleus in advanced Parkinson's disease. N Engl J Med. 1998 Oct 15;339(16):1105-11.

Study ID Numbers:	DBSsed1-HMO-CTIL, HTA3769
Study First Received:	July 23, 2006
Last Updated:	November 1, 2007
ClinicalTrials.gov Identifier:	NCT00355927
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:

Deep brain stimulation
Microelectrode recordings
Basal Ganglia
Sedation
Propofol

Study placed in the following topic categories:

Dystonic Disorders
Ganglion Cysts
Basal Ganglia Diseases
Dystonia
Central Nervous System Diseases
Tourette Syndrome
Tic Disorders
Neurodegenerative Diseases
Brain Diseases
Dyskinesias
Tics

Signs and Symptoms
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Mental Disorders
Parkinson Disease
Movement Disorders
Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Gilles de la Tourette's syndrome
Parkinsonian Disorders
Propofol

Additional relevant MeSH terms:

Anesthetics, Intravenous
Disease
Nervous System Diseases
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Pharmacologic Actions

Pathologic Processes
Anesthetics, General
Syndrome
Therapeutic Uses
Hypnotics and Sedatives
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009