Sedation During Microelectrode Recordings Before Deep Brain Stimulation for Movement Disorders.
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|ClinicalTrials.gov Identifier: NCT00355927|
Recruitment Status : Unknown
Verified August 2006 by Hadassah Medical Organization.
Recruitment status was: Enrolling by invitation
First Posted : July 25, 2006
Last Update Posted : November 2, 2007
|Condition or disease||Intervention/treatment||Phase|
|Movement Disorders Parkinson Disease Parkinsonian Disorders Dystonia Tourette Syndrome||Procedure: Sedation with IV propofol||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Changes of the Neuronal Activity in the Subthalamic Nucleus Under Propofol Sedation During Stereotactic Electrode Implantation.|
|Study Start Date :||September 2006|
|Estimated Study Completion Date :||July 2008|
- Procedure: Sedation with IV propofol
Propofol(50 microgram/kg/min.), I.V. for 5-10 minutes, Until a level of light sedation is achievedOther Name: DIPROFOL 1%; TAROPharmceutical Indusries Ltd. IL.
- 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 ]
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
|Hadassah Medical Organization|
|Jerusalem, Israel, 91120|
|Principal Investigator:||Dan Eimerl, MD||Hadassah Medical Organization|
|Principal Investigator:||Zvi Israel, MD||Hadassah Medical Organization|