Cerebral Metabolic Changes Associated With Thalamic Stimulation
NCT ID: NCT01141764
Last Updated: 2014-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
4 participants
INTERVENTIONAL
2010-03-31
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Positron Emission Tomography (PET) Scan
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.
Magnetic Resonance Imaging (MRI)
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
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.
Interventions
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Positron Emission Tomography (PET) Scan
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.
Magnetic Resonance Imaging (MRI)
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
85 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
The Hospital for Sick Children
OTHER
Responsible Party
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Elysa Widjaja
Staff Neuroradiologist
Principal Investigators
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Elysa Widjaja, MD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children, Toronto Canada
Locations
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The Hospital for Sick Children
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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1000014496
Identifier Type: -
Identifier Source: org_study_id