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Sedation During Microelectrode Recordings Before Deep Brain Stimulation for Movement Disorders.

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2006 by Hadassah Medical Organization.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00355927
First Posted: July 25, 2006
Last Update Posted: November 2, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Changes of the Neuronal Activity in the Subthalamic Nucleus Under Propofol Sedation During Stereotactic Electrode Implantation.

Resource links provided by NLM:


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:
    Procedure: Sedation with IV propofol
    Propofol(50 microgram/kg/min.), I.V. for 5-10 minutes, Until a level of light sedation is achieved
    Other Name: DIPROFOL 1%; TAROPharmceutical Indusries Ltd. IL.
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00355927     History of Changes
Other Study ID Numbers: DBSsed1-HMO-CTIL
HTA3769
First Submitted: July 23, 2006
First Posted: July 25, 2006
Last Update Posted: November 2, 2007
Last Verified: August 2006

Keywords provided by Hadassah Medical Organization:
Deep brain stimulation
Microelectrode recordings
Basal Ganglia
Sedation
Propofol

Additional relevant MeSH terms:
Disease
Parkinson Disease
Dystonia
Tourette Syndrome
Movement Disorders
Parkinsonian Disorders
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Tic Disorders
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics