Cerebral Metabolic Changes Associated With Thalamic Stimulation
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy |
Procedure: Positron Emission Tomography (PET) Scan Procedure: Magnetic Resonance Imaging (MRI) Other: Neuropsychological Testing |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Cerebral Metabolic Changes Associated With Thalamic Stimulation |
- Areas of the brain with low activity [ Time Frame: within 30 days of enrollment in the study ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]One session of neuropsychological testing will be done in order to assess the subject's ability to learn and understand.
| Estimated Enrollment: | 8 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Esther Bui | (416) 603-4931 | esther.bui@uhn.on.ca |
| Canada, Ontario | |
| The Hospital for Sick Children | Recruiting |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Contact: Nicole Brown 416 813 7654 ext 4866 nicole-e.brown@sickkids.ca | |
| Principal Investigator: Elysa Widjaja, MD | |
| Sub-Investigator: Danielle Andrade, MD | |
| Sub-Investigator: Martin Charron, MD | |
| Toronto Western Hospital | Recruiting |
| Toronto, Ontario, Canada, M5T 2S8 | |
| Contact: Esther Bui (416) 603-4931 esther.bui@uhn.on.ca | |
| Principal Investigator: Danielle Andrade, MD | |
| Sub-Investigator: Esther Bui, MD | |
| Sub-Investigator: Mary Pat McAndrews, MD | |
| Sub-Investigator: Andres Lozano, MD | |
| Sub-Investigator: Richard Wennberg, MD | |
| Sub-Investigator: Clement Hamani, MD | |
| Principal Investigator: | Elysa Widjaja, MD | The Hospital for Sick Children, Toronto Canada |
More Information
No publications provided
| Responsible Party: | Dr. Elysa Widjaja/Principal Investigator, The Hospital for SIck Children |
| ClinicalTrials.gov Identifier: | NCT01141764 History of Changes |
| Other Study ID Numbers: | 1000014496 |
| Study First Received: | June 7, 2010 |
| Last Updated: | June 9, 2010 |
| Health Authority: | Canada: Health Canada |
Keywords provided by The Hospital for Sick Children:
|
pediatrics Epilepsy Deep Brain Stimulation Positron Emission Tomography |
Additional relevant MeSH terms:
|
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013