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Very slow and infrequent recruitment, availability of the imaging procedure at Adult Centre
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| Name | Class |
|---|---|
| University Health Network, Toronto | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positron Emission Tomography (PET) Scan | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Patients who:
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| Name | Affiliation | Role |
|---|---|---|
| Elysa Widjaja, MD | The Hospital for Sick Children, Toronto Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada | ||
| Toronto Western Hospital |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| C062942 | 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole |
| D009483 | Neuropsychological Tests |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D011581 | Psychological Tests |
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| Magnetic Resonance Imaging (MRI) | Procedure | 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. |
|
| Neuropsychological Testing | Other | 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. |
|
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 |
| Toronto |
| Ontario |
| M5T 2S8 |
| Canada |
| D004191 | Behavioral Disciplines and Activities |