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

NCT ID: NCT00355927

Last Updated: 2007-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-07-31

Brief Summary

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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

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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.

Conditions

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Movement Disorders Parkinson Disease Parkinsonian Disorders Dystonia Tourette Syndrome

Keywords

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Deep brain stimulation Microelectrode recordings Basal Ganglia Sedation Propofol

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Sedation with IV propofol

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

Intervention Type PROCEDURE

Other Intervention Names

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DIPROFOL 1%; TAROPharmceutical Indusries Ltd. IL.

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Principal Investigators

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Dan Eimerl, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Zvi Israel, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

References

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

Reference Type BACKGROUND
PMID: 16011063 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15023817 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9770557 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32884017 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20841416 (View on PubMed)

Other Identifiers

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HTA3769

Identifier Type: -

Identifier Source: secondary_id

DBSsed1-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id