EpilepsyPhase 3NCT01141764
Cerebral Metabolic Changes Associated With Thalamic Stimulation
A Phase 3 study testing Positron Emission Tomography (PET) Scan, Magnetic Resonance Imaging (MRI) and Neuropsychological Testing in people with Epilepsy, run by The Hospital for Sick Children at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Positron Emission Tomography (PET) Scan, Magnetic Resonance Imaging (MRI) and Neuropsychological Testing
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesCanada
- Study dates
- Mar 2010to Feb 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
About this study
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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Positron Emission Tomography (PET) Scan, Magnetic Resonance Imaging (MRI), Neuropsychological Testing
- Keywords
- pediatrics, Epilepsy, Deep Brain Stimulation, Positron Emission Tomography
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron Emission Tomography (PET) ScanProcedure or surgery
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)Procedure or surgery
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.
Neuropsychological TestingOther
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 | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Positron Emission Tomography (PET) Scan; Procedure: Magnetic Resonance Imaging (MRI); Other: Neuropsychological Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 30 days of enrollment in the study
Secondary outcomes (2)
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.
Measured: within 30 days of enrollment in the study
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.
Measured: within 30 days of enrollment in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startMar 2010
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Very slow and infrequent recruitment, availability of the imaging procedure at Adult Centre
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Principal investigator, Elysa Widjaja, The Hospital for Sick Children
- Investigators
- Elysa Widjaja, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141764
- Sponsor's protocol ID
- 1000014496
- Status last verified
- Nov 2014
- First submitted
- 7 Jun 2010
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Metabolic Changes Associated With Thalamic Stimulation
- ClinicalTrials.gov ID
- NCT01141764
- Acronym / sponsor ID
- 1000014496
- Conditions
- Epilepsy
- Keywords
- pediatrics, Epilepsy, Deep Brain Stimulation, Positron Emission Tomography
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Very slow and infrequent recruitment, availability of the imaging procedure at Adult Centre
- Enrolment
- 4 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- Mar 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 10 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Procedure: Positron Emission Tomography (PET) Scan, Procedure: Magnetic Resonance Imaging (MRI), Other: Neuropsychological TestingIn 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positron Emission Tomography (PET) ScanThe 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 or surgery | Study Group |
| 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. | Procedure or surgery | Study Group |
| Neuropsychological TestingOn 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. | Other | Study Group |
Primary outcome
Areas of the brain with low activity
Time frame: within 30 days of enrollment in the study
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.
2 secondary outcomes
Brain Abnormalities
Time frame: within 30 days of enrollment in the study
Ability to learn and understand
Time frame: within 30 days of enrollment in the study
Results and safety
The study was stopped early (reason given: Very slow and infrequent recruitment, availability of the imaging procedure at Adult Centre). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elysa Widjaja, MD principal investigator
The Hospital for Sick Children, Toronto Canada
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Positron Emission Tomography (PET) Scan, Magnetic Resonance Imaging (MRI) and Neuropsychological Testing in people with Epilepsy, run by The Hospital for Sick Children at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Very slow and infrequent recruitment, availability of the imaging procedure at Adult Centre). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Areas of the brain with low activity (time frame: within 30 days of enrollment in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2014; AzTrials last refreshed its copy on 30 Oct 2026.