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

Overview

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.

Full Title of Study: “Changes of the Neuronal Activity in the Subthalamic Nucleus Under Propofol Sedation During Stereotactic Electrode Implantation.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

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.

Interventions

  • Procedure: Sedation with IV propofol
    • Propofol(50 microgram/kg/min.), I.V. for 5-10 minutes, Until a level of light sedation is achieved

Clinical Trial Outcome Measures

Primary 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hadassah Medical Organization
  • Overall Official(s)
    • Dan Eimerl, MD, Principal Investigator, Hadassah Medical Organization
    • Zvi Israel, MD, Principal Investigator, Hadassah Medical Organization

References

Israel Z, Hassin-Baer S. Subthalamic stimulation for Parkinson's disease. Isr Med Assoc J. 2005 Jul;7(7):458-63.

Maltete 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.

Limousin 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.

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