Cerebral Metabolic Changes Associated With Thalamic Stimulation
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | June 7, 2010 | ||||
| Last Updated Date | June 9, 2010 | ||||
| Start Date ICMJE | March 2010 | ||||
| Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01141764 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cerebral Metabolic Changes Associated With Thalamic Stimulation | ||||
| Official Title ICMJE | Cerebral Metabolic Changes Associated With Thalamic Stimulation | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Epilepsy | ||||
| Intervention ICMJE |
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| Study Arm (s) | 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. Interventions:
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 8 | ||||
| Estimated Completion Date | July 2011 | ||||
| Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Patients who:
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| Gender | Both | ||||
| Ages | 18 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01141764 | ||||
| Other Study ID Numbers ICMJE | 1000014496 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Elysa Widjaja/Principal Investigator, The Hospital for SIck Children | ||||
| Study Sponsor ICMJE | The Hospital for Sick Children | ||||
| Collaborators ICMJE | University Health Network, Toronto | ||||
| Investigators ICMJE |
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| Information Provided By | The Hospital for Sick Children | ||||
| Verification Date | June 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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