Sedation During Microelectrode Recordings Before Deep Brain Stimulation for Movement Disorders.
Changes of the Neuronal Activity in the Subthalamic Nucleus Under Propofol Sedation During Stereotactic Electrode Implantation.
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2006
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2006
CompletedFirst Posted
Study publicly available on registry
July 25, 2006
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedNovember 2, 2007
August 1, 2006
July 23, 2006
November 1, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in the electrical activity of neuron cells of the basal ganglia in the examined patients
Within 24 hours needed to analyse the data
Interventions
Propofol(50 microgram/kg/min.), I.V. for 5-10 minutes, Until a level of light sedation is achieved
Eligibility Criteria
You may qualify if:
- Candidate for Deep Brain Stimulation Surgery.
- Informed concent obtained.
You may not qualify if:
- Suspected difficult intubation (by history or physical examination).
- Allergy to Propofol, eggs or soy-beans.
- History of sleep apnea syndrome.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah Medical Organization
Jerusalem, 91120, Israel
Related Publications (5)
Israel Z, Hassin-Baer S. Subthalamic stimulation for Parkinson's disease. Isr Med Assoc J. 2005 Jul;7(7):458-63.
PMID: 16011063BACKGROUNDMaltete 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. doi: 10.1001/archneur.61.3.390.
PMID: 15023817BACKGROUNDLimousin 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. doi: 10.1056/NEJM199810153391603.
PMID: 9770557BACKGROUNDBenady A, Zadik S, Eimerl D, Heymann S, Bergman H, Israel Z, Raz A. Sedative drugs modulate the neuronal activity in the subthalamic nucleus of parkinsonian patients. Sci Rep. 2020 Sep 3;10(1):14536. doi: 10.1038/s41598-020-71358-3.
PMID: 32884017DERIVEDRaz A, Eimerl D, Zaidel A, Bergman H, Israel Z. Propofol decreases neuronal population spiking activity in the subthalamic nucleus of Parkinsonian patients. Anesth Analg. 2010 Nov;111(5):1285-9. doi: 10.1213/ANE.0b013e3181f565f2. Epub 2010 Sep 14.
PMID: 20841416DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dan Eimerl, MD
Hadassah Medical Organization
- PRINCIPAL INVESTIGATOR
Zvi Israel, MD
Hadassah Medical Organization
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 23, 2006
First Posted
July 25, 2006
Study Start
September 1, 2006
Study Completion
July 1, 2008
Last Updated
November 2, 2007
Record last verified: 2006-08