Cerebral Metabolic Changes Associated With Thalamic Stimulation

This study is currently recruiting participants.
Verified December 2013 by The Hospital for Sick Children
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
Elysa Widjaja, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01141764
First received: June 7, 2010
Last updated: December 2, 2013
Last verified: December 2013

June 7, 2010
December 2, 2013
March 2010
July 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01141764 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Cerebral Metabolic Changes Associated With Thalamic Stimulation
Cerebral Metabolic Changes Associated With Thalamic Stimulation

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.

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.

Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

  • Procedure: 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.
  • 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.
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:
  • Procedure: Positron Emission Tomography (PET) Scan
  • Procedure: Magnetic Resonance Imaging (MRI)
  • Other: Neuropsychological Testing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
8
July 2016
July 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact: Esther Bui (416) 603-4931 esther.bui@uhn.on.ca
Canada
 
NCT01141764
1000014496
No
Elysa Widjaja, The Hospital for Sick Children
The Hospital for Sick Children
University Health Network, Toronto
Principal Investigator: Elysa Widjaja, MD The Hospital for Sick Children, Toronto Canada
The Hospital for Sick Children
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP