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)
NCT ID: NCT01037686
Last Updated: 2009-12-23
Study Results
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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UNKNOWN
NA
120 participants
INTERVENTIONAL
2006-02-28
2010-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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PD, DBS, healthy controls
Patients with idiopathic PD before or after DBS surgery (during on or off-stimulation) and healthy controls.
Injection of 15mCi of Tc-ECD and scanning by SPECT camera
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.
Semantic verbal fluency task performance
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.
Turning off the stimulator
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.
Interventions
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Injection of 15mCi of Tc-ECD and scanning by SPECT camera
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.
Semantic verbal fluency task performance
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.
Turning off the stimulator
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.
Eligibility Criteria
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Inclusion Criteria
* For control group - age-matched to study groups
Exclusion Criteria
* Other neurological conditions
* Other physical disease
* Intolerance of "off stimulation" state
* Involuntary head motions
* Hearing deficits
40 Years
80 Years
ALL
Yes
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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Sheba Medical Center
Locations
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Movement Disorders Clinic, Sheba Medical Center
Ramat Gan, , Israel
Countries
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Central Contacts
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Facility Contacts
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Sharon Hassin, MD
Role: primary
Yafit Kuttner, B.Sc
Role: backup
Other Identifiers
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SHEBA-05-3972-SH-CTIL
Identifier Type: -
Identifier Source: org_study_id