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)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Exploring the Effect of Electrode Implantation for DBS on Brain Function During Rest and During Semantic Verbal Fluency Task Using SPECT With Tc-ECD

Conditions
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Parkinson's Disease, Deep Brain Stimulation

Intervention / Treatment
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* Radiation: Injection of 15mCi of Tc-ECD and scanning by SPECT camera
* Behavioral: Semantic verbal fluency task performance
* Device: Turning off the stimulator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PD, DBS, healthy controls<br>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<br>* 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.<br>Behavioral: Semantic verbal fluency task performance<br>* 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.<br>Device: Turning off the stimulator<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CBF values in different brain regions |  | 3 months to 2 years post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of words produced in the semantic fluency task |  | 3 months to 2 years post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PD, DBS