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

Primary Purpose

Movement Disorders, Parkinson Disease, Parkinsonian Disorders

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Sedation with IV propofol

About this trial

This is an interventional treatment trial for Movement Disorders focused on measuring Deep brain stimulation, Microelectrode recordings, Basal Ganglia, Sedation, Propofol

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hadassah Medical Organization

Outcomes

Primary Outcome Measures

Changes in the electrical activity of neuron cells of the basal ganglia in the examined patients

Secondary Outcome Measures

Full Information

NCT ID

NCT00355927

First Posted

July 23, 2006

Last Updated

November 1, 2007

Sponsor

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT00355927

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2006

Overall Recruitment Status

Unknown status

Study Start Date

September 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Hadassah Medical Organization

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Deep brain stimulation, Microelectrode recordings, Basal Ganglia, Sedation, Propofol

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Sedation with IV propofol

Other Intervention Name(s)

DIPROFOL 1%; TAROPharmceutical Indusries Ltd. IL.

Intervention Description

Propofol(50 microgram/kg/min.), I.V. for 5-10 minutes, Until a level of light sedation is achieved

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dan Eimerl, MD

Organizational Affiliation

Hadassah Medical Organization

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Zvi Israel, MD

Organizational Affiliation

Hadassah Medical Organization

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hadassah Medical Organization

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

16011063

Citation

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

Results Reference

background

PubMed Identifier

15023817

Citation

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.

Results Reference

background

PubMed Identifier

9770557

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. doi: 10.1056/NEJM199810153391603.

Results Reference

background

PubMed Identifier

32884017

Citation

Benady 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.

Results Reference

derived

PubMed Identifier

20841416

Citation

Raz 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.

Results Reference

derived

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

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