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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|ClinicalTrials.gov Identifier: NCT01037686|
Recruitment Status : Unknown
Verified December 2009 by Sheba Medical Center.
Recruitment status was: Recruiting
First Posted : December 23, 2009
Last Update Posted : December 23, 2009
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease Deep Brain Stimulation||Radiation: Injection of 15mCi of Tc-ECD and scanning by SPECT camera Behavioral: Semantic verbal fluency task performance Device: Turning off the stimulator||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|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 Start Date :||February 2006|
|Estimated Primary Completion Date :||April 2010|
|Estimated Study Completion Date :||October 2010|
PD, DBS, healthy controls
Patients with idiopathic PD before or after DBS surgery (during on or off-stimulation) and healthy controls.
Radiation: 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.
Behavioral: 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.
Device: 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.
- CBF values in different brain regions [ Time Frame: 3 months to 2 years post-surgery ]
- Number of words produced in the semantic fluency task [ Time Frame: 3 months to 2 years post-surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01037686
|Contact: Sharon Hassin, MDfirstname.lastname@example.org|
|Contact: Yafit Kuttner, B.Scemail@example.com|
|Movement Disorders Clinic, Sheba Medical Center||Recruiting|
|Ramat Gan, Israel, 52621|
|Contact: Sharon Hassin, MD 97235305791 firstname.lastname@example.org|
|Contact: Yafit Kuttner, B.Sc 97235304753 email@example.com|
|Principal Investigator: Sharon Hassin, MD|