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Cerebral Metabolic Changes Associated With Thalamic Stimulation

This study has been terminated.
(Very slow and infrequent recruitment, availability of the imaging procedure at Adult Centre)
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: November 20, 2014
Last verified: November 2014
  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

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 4
Study Start Date: March 2010
Study Completion Date: February 2014
Primary Completion Date: February 2014 (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.

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.

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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141764

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
The Hospital for Sick Children
University Health Network, Toronto
Investigators
Principal Investigator: Elysa Widjaja, MD The Hospital for Sick Children, Toronto Canada
  More Information

No publications provided

Responsible Party: Elysa Widjaja, Staff Neuroradiologist, 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: November 20, 2014
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 November 20, 2014