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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00355927
First received: July 23, 2006
Last updated: November 1, 2007
Last verified: August 2006
  Purpose

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.


Condition Intervention
Movement Disorders
Parkinson Disease
Parkinsonian Disorders
Dystonia
Tourette Syndrome
Procedure: Sedation with IV propofol

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Changes of the Neuronal Activity in the Subthalamic Nucleus Under Propofol Sedation During Stereotactic Electrode Implantation.

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome 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 ]

Estimated Enrollment: 20
Study Start Date: September 2006
Estimated Study Completion Date: July 2008
Intervention Details:
    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.
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355927

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Dan Eimerl, MD Hadassah Medical Organization
Principal Investigator: Zvi Israel, MD Hadassah Medical Organization
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00355927     History of Changes
Other Study ID Numbers: DBSsed1-HMO-CTIL, HTA3769
Study First Received: July 23, 2006
Last Updated: November 1, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
Deep brain stimulation
Microelectrode recordings
Basal Ganglia
Sedation
Propofol

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Movement Disorders
Parkinson Disease
Tourette Syndrome
Parkinsonian Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Diseases
Basal Ganglia Diseases
Brain Diseases
Neurodegenerative Diseases
Tic Disorders
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Mental Disorders Diagnosed in Childhood
Mental Disorders
Propofol
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on July 20, 2014