Cerebral Metabolic Changes Associated With Thalamic Stimulation
Primary Purpose
Epilepsy
Status
Terminated
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Positron Emission Tomography (PET) Scan
Magnetic Resonance Imaging (MRI)
Neuropsychological Testing
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring pediatrics, Epilepsy, Deep Brain Stimulation, Positron Emission Tomography
Eligibility Criteria
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.
Sites / Locations
- The Hospital for Sick Children
- Toronto Western Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Group
Arm Description
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.
Outcomes
Primary Outcome Measures
Areas of the brain with low activity
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
Brain Abnormalities
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
One session of neuropsychological testing will be done in order to assess the subject's ability to learn and understand.
Full Information
NCT ID
NCT01141764
First Posted
June 7, 2010
Last Updated
November 20, 2014
Sponsor
The Hospital for Sick Children
Collaborators
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT01141764
Brief Title
Cerebral Metabolic Changes Associated With Thalamic Stimulation
Official Title
Cerebral Metabolic Changes Associated With Thalamic Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
Very slow and infrequent recruitment, availability of the imaging procedure at Adult Centre
Study Start Date
March 2010 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
pediatrics, Epilepsy, Deep Brain Stimulation, Positron Emission Tomography
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography (PET) Scan
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging (MRI)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Neuropsychological Testing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Areas of the brain with low activity
Description
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.
Time Frame
within 30 days of enrollment in the study
Secondary Outcome Measure Information:
Title
Brain Abnormalities
Description
One Magnetic Resonance Imaging (MRI) scan will be used to take detailed images of the brain and detect whether there are any abnormalities.
Time Frame
within 30 days of enrollment in the study
Title
Ability to learn and understand
Description
One session of neuropsychological testing will be done in order to assess the subject's ability to learn and understand.
Time Frame
within 30 days of enrollment in the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elysa Widjaja, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
12. IPD Sharing Statement
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Cerebral Metabolic Changes Associated With Thalamic Stimulation
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