Cerebral Metabolic Changes Associated With Thalamic Stimulation

Epilepsy Clinical Trial

Official title:

Cerebral Metabolic Changes Associated With Thalamic Stimulation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01141764
• Other study ID #: 1000014496
• Status: Terminated
• Phase: Phase 3
• First received: June 7, 2010
• Last updated: November 20, 2014
• Start date: March 2010
• Est. completion date: February 2014

Study information

• Verified date: November 2014
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within 30 days of enrollment in the study	No
Secondary	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.	within 30 days of enrollment in the study	No
Secondary	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.	within 30 days of enrollment in the study	No