Cerebral Metabolic Changes Associated With Thalamic Stimulation
- Conditions
- Epilepsy
- Interventions
- Procedure: Positron Emission Tomography (PET) ScanProcedure: Magnetic Resonance Imaging (MRI)Other: Neuropsychological Testing
- Registration Number
- NCT01141764
- Lead Sponsor
- The Hospital for Sick Children
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
- 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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Study Group Magnetic Resonance Imaging (MRI) 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. Study Group Neuropsychological Testing 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. Study Group Positron Emission Tomography (PET) Scan 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.
- Primary Outcome Measures
Name Time Method Areas of the brain with low activity 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.
- Secondary Outcome Measures
Name Time Method Brain Abnormalities 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 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.
Trial Locations
- Locations (2)
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada