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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00355927
• Other study ID #: DBSsed1-HMO-CTIL
• Secondary ID: HTA3769
• Status: Enrolling by invitation
• Phase: N/A
• First received: July 23, 2006
• Last updated: November 1, 2007
• Start date: September 2006
• Est. completion date: July 2008

Study information

• Verified date: August 2006
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Dystonia
• Movement Disorders
• Parkinson Disease
• Parkinsonian Disorders
• Tourette Syndrome

Intervention

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

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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

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. — View Citation

Maltête 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the electrical activity of neuron cells of the basal ganglia in the examined patients		Within 24 hours needed to analyse the data