Cerebral Metabolic Changes Associated With Thalamic Stimulation
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|ClinicalTrials.gov Identifier: NCT01141764|
Recruitment Status : Terminated (Very slow and infrequent recruitment, availability of the imaging procedure at Adult Centre)
First Posted : June 10, 2010
Last Update Posted : November 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Procedure: Positron Emission Tomography (PET) Scan Procedure: Magnetic Resonance Imaging (MRI) Other: Neuropsychological Testing||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cerebral Metabolic Changes Associated With Thalamic Stimulation|
|Study Start Date :||March 2010|
|Primary Completion Date :||February 2014|
|Study Completion Date :||February 2014|
Experimental: Study Group
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
Procedure: Magnetic Resonance Imaging (MRI)
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.
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.Other: Neuropsychological Testing
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.
- Areas of the brain with low activity [ Time Frame: within 30 days of enrollment in the study ]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.
- Brain Abnormalities [ Time Frame: within 30 days of enrollment in the study ]One Magnetic Resonance Imaging (MRI) scan will be used to take detailed images of the brain and detect whether there are any abnormalities.
- Ability to learn and understand [ Time Frame: within 30 days of enrollment in the study ]One session of neuropsychological testing will be done in order to assess the subject's ability to learn and understand.
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): NCT01141764
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Toronto Western Hospital|
|Toronto, Ontario, Canada, M5T 2S8|
|Principal Investigator:||Elysa Widjaja, MD||The Hospital for Sick Children, Toronto Canada|