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Clinical Trials/NCT00355927
NCT00355927UnknownNot Applicable

Changes of the Neuronal Activity in the Subthalamic Nucleus Under Propofol Sedation During Stereotactic Electrode Implantation.

Hadassah Medical Organization1 site in 1 country20 target enrollmentStarted: September 1, 2006Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
20
Locations
1
Primary Endpoint
Changes in the electrical activity of neuron cells of the basal ganglia in the examined patients

Study Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (1)

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