Sedation During Microelectrode Recordings Before Deep Brain Stimulation for Movement Disorders.
This study is enrolling participants by invitation only.
Sponsor:
Hadassah Medical Organization
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00355927
First received: July 23, 2006
Last updated: November 1, 2007
Last verified: August 2006
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 23, 2006 | ||||||||
| Last Updated Date | November 1, 2007 | ||||||||
| Start Date ICMJE | September 2006 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Changes of the electrical activity of single neurons due to propofol sedation. | ||||||||
| Change History | Complete list of historical versions of study NCT00355927 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Sedation During Microelectrode Recordings Before Deep Brain Stimulation for Movement Disorders. | ||||||||
| Official Title ICMJE | Changes of the Neuronal Activity in the Subthalamic Nucleus Under Propofol Sedation During Stereotactic Electrode Implantation. | ||||||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | 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. |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Estimated Completion Date | July 2008 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Israel | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00355927 | ||||||||
| Other Study ID Numbers ICMJE | DBSsed1-HMO-CTIL, HTA3769 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Hadassah Medical Organization | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Hadassah Medical Organization | ||||||||
| Verification Date | August 2006 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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