Cerebral Metabolic Changes Associated With Thalamic Stimulation

Study Overview
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Brief Summary
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The purpose of this research study is to evaluate the brain circuits function and circuits involved in the mechanism of thalamic DBS in patients with medically refractory epilepsy.

Detailed Description
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Deep brain stimulation (DBS) of the anterior nucleus of the thalamus in patients with medically refractory epilepsy has been shown to be efficacious. Studies have estimated a 46-76% reduction in seizures relative to the baseline. However, the exact anatomic circuitry involved in the mechanism of DBS in epilepsy remains unknown. Positron emission tomography (PET) studies can provide clues to the metabolic activity associated with DBS activation. In our study, patients will be scanned with their DBS electrodes turned on and off. PET data captured during these two distinct states may show characteristic differences in cerebral glucose metabolism and modulatory effects of surrounding cerebral structures, thus providing clues to how DBS works to prevent seizures.

Official Title
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Cerebral Metabolic Changes Associated With Thalamic Stimulation

Conditions
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Epilepsy

Intervention / Treatment
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* Procedure: Positron Emission Tomography (PET) Scan
* Procedure: Magnetic Resonance Imaging (MRI)
* Other: Neuropsychological Testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-85 years old currently have DBS implanted for medically refractory epilepsy Women of childbearing age will be required to use established contraceptive methods while enrolled in the study. Exclusion Criteria: Patients who: are < 18 years of age or > 85 years of age are medically unstable are women who are potentially pregnant, pregnant or nursing have had PET imaging within 1 year.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>In our study, patients will be scanned with their DBS electrodes turned on and off. Participation involves undergoing 2 separate PET scans on 2 separate days. The MRI and neuropsychological tests will either be performed on the same day as one of the PET scans or on a separate day. Procedures performed in this study are not part of the standard management of epilepsy. | Procedure: Positron Emission Tomography (PET) Scan<br>* The PET procedure consists of an intravenous injection of 18F-FDG followed by a 45-minute period of quiet resting. PET images will be acquired on an integrated PET/CT scanner. This process will be repeated with the stimulator on during the first PET image acquisition and off during the second PET image acquisition. On and off PET image acquisitions will be performed on two separate days.<br>Procedure: Magnetic Resonance Imaging (MRI)<br>* MRI will be performed on a 1.5T system, using a combination of different sequences including sagittal T1, coronal and axial T2, FLAIR and proton density and axial 3D T1 weighted images.<br>Other: Neuropsychological Testing<br>* On the same day or separate visit, depending on the timing of the PET imaging, they will be required to attend one half-day session for neuropsychological testing. Patients will arrive at the Toronto Western Hospital, the stimulator will be turned off for 30 minutes prior to neuropsychological testing with testing repeated with the stimulator on.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Areas of the brain with low activity | This measure will be based on the results of two PET scans done on separate days. The stimulator will be on during the first PET image acquisition and off during the second PET image acquisition. | within 30 days of enrollment in the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain Abnormalities | One Magnetic Resonance Imaging (MRI) scan will be used to take detailed images of the brain and detect whether there are any abnormalities. | within 30 days of enrollment in the study | 
| Ability to learn and understand | One session of neuropsychological testing will be done in order to assess the subject's ability to learn and understand. | within 30 days of enrollment in the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatrics, Epilepsy, Deep Brain Stimulation, Positron Emission Tomography