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The Effect of Electrode Implantation for Deep Brain Stimulation (DBS) on Brain Function Using Single Photon Emission Computed Tomography (SPECT) With Technetium-99m-ethyl Cysteinatedimer (Tc-ECD)

Primary Purpose

Parkinson's Disease, Deep Brain Stimulation

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Injection of 15mCi of Tc-ECD and scanning by SPECT camera
Semantic verbal fluency task performance
Turning off the stimulator
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson's Disease focused on measuring PD, DBS

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Progressive idiopathic PD
  • For control group - age-matched to study groups

Exclusion Criteria:

  • Progressive dementia or other psychiatric disorders
  • Other neurological conditions
  • Other physical disease
  • Intolerance of "off stimulation" state
  • Involuntary head motions
  • Hearing deficits

Sites / Locations

  • Movement Disorders Clinic, Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

PD, DBS, healthy controls

Arm Description

Patients with idiopathic PD before or after DBS surgery (during on or off-stimulation) and healthy controls.

Outcomes

Primary Outcome Measures

CBF values in different brain regions

Secondary Outcome Measures

Number of words produced in the semantic fluency task

Full Information

First Posted
September 29, 2009
Last Updated
December 22, 2009
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01037686
Brief Title
The Effect of Electrode Implantation for Deep Brain Stimulation (DBS) on Brain Function Using Single Photon Emission Computed Tomography (SPECT) With Technetium-99m-ethyl Cysteinatedimer (Tc-ECD)
Official Title
Exploring the Effect of Electrode Implantation for DBS on Brain Function During Rest and During Semantic Verbal Fluency Task Using SPECT With Tc-ECD
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2006 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
October 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to explore the effect of subthalamic nucleus (STN)-DBS surgery and stimulation in PD (Parkinson's disease) patients on regional cerebral blood (CBF) flow during cognitive task performance or at rest.
Detailed Description
In this study subjects undergo SPECT scans for CBF mapping. PD patients before the surgery and healthy controls undergo two scans. PD patients after the surgery undergo four scans. PD patients who undergo two scans before the surgery, undergo only two scans after the surgery. Uptake of Tc-ECD, a CBF radiotracer, is done in the following conditions: For PD patients before the surgery - during the performance of the semantic verbal fluency task or at rest (total of 2 scans). For PD patients after the surgery- during the performance of the semantic verbal fluency task or at rest, either at on-stimulation or off-stimulation condition (total of 4 scans). The stimulator is turned off by the neurologist for 10 min. PD patients before and after the surgery- during performance of the semantic verbal fluency task or at rest before the surgery and during performance of the semantic verbal fluency task or at rest after the surgery only at off-stimulation condition (Total of 4 scans). Healthy controls - during the performance of the semantic verbal fluency task or at rest (total of 2 scans). Following the Tc-ECD injection, the subjects are scanned by Irix SPECT camera for 15min. Scans are analyzed and the regional CBF is measured using imaging software. Statistical analysis is done to discover the effect of the surgery, stimulation and the disease on blood flow at rest and during task performance. In addition, differences between groups in number of words produced during the task are also statistically analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Deep Brain Stimulation
Keywords
PD, DBS

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PD, DBS, healthy controls
Arm Type
Other
Arm Description
Patients with idiopathic PD before or after DBS surgery (during on or off-stimulation) and healthy controls.
Intervention Type
Radiation
Intervention Name(s)
Injection of 15mCi of Tc-ECD and scanning by SPECT camera
Intervention Description
All subjects (PD patients with or without DBS and healthy controls) will be injected with 15mCi of Tc-ECD and afterwards will be scanned by an Irix SPECT camera.
Intervention Type
Behavioral
Intervention Name(s)
Semantic verbal fluency task performance
Intervention Description
All Subjects (PD patients with or without DBS and healthy controls) before one of the two scans will perform the semantic verbal fluency task during the Tc-ECD uptake for 9 minutes. Before the other scan subjects will be at rest.
Intervention Type
Device
Intervention Name(s)
Turning off the stimulator
Intervention Description
For PD patients treated with DBS, the neurologist will turn off the stimulator after the injection of Tc-ECD for ten minutes and then turn it back on.
Primary Outcome Measure Information:
Title
CBF values in different brain regions
Time Frame
3 months to 2 years post-surgery
Secondary Outcome Measure Information:
Title
Number of words produced in the semantic fluency task
Time Frame
3 months to 2 years post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Progressive idiopathic PD For control group - age-matched to study groups Exclusion Criteria: Progressive dementia or other psychiatric disorders Other neurological conditions Other physical disease Intolerance of "off stimulation" state Involuntary head motions Hearing deficits
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon Hassin, MD
Phone
97235305791
Email
sharon.hassin@sheba.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Yafit Kuttner, B.Sc
Phone
97235304753
Email
yafitkuttner@yahoo.com
Facility Information:
Facility Name
Movement Disorders Clinic, Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Hassin, MD
Phone
97235305791
Email
sharon.hassin@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
Yafit Kuttner, B.Sc
Phone
97235304753
Email
yafitkuttner@yahoo.com
First Name & Middle Initial & Last Name & Degree
Sharon Hassin, MD

12. IPD Sharing Statement

Learn more about this trial

The Effect of Electrode Implantation for Deep Brain Stimulation (DBS) on Brain Function Using Single Photon Emission Computed Tomography (SPECT) With Technetium-99m-ethyl Cysteinatedimer (Tc-ECD)

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