Cerebral Metabolic Changes Associated With Thalamic Stimulation

NCT01141764 | Terminated Phase 3

• 1 other identifier: 1000014496
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

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.

Conditions

Epilepsy

Keywords

pediatrics; Epilepsy; Deep Brain Stimulation; Positron Emission Tomography

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Brain Abnormalities

  within 30 days of enrollment in the study

• Ability to learn and understand

  within 30 days of enrollment in the study

Study Arms (1)

Study Group

EXPERIMENTAL

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; Procedure: Magnetic Resonance Imaging (MRI); Other: Neuropsychological Testing

Interventions

Positron Emission Tomography (PET) Scan PROCEDURE

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.

Study Group

Magnetic Resonance Imaging (MRI) PROCEDURE

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.

Study Group

Neuropsychological Testing OTHER

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.

Study Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• University Health Network, Toronto: collaborator

Study Sites (2)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Magnetic Resonance Spectroscopy; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole; Neuropsychological Tests

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Elysa Widjaja, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Neuroradiologist

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 10, 2010
• Study Start: March 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: November 21, 2014

Record last verified: 2014-11

Locations

CA (2)