Deep Brain Stimulation for Frontotemporal Dementia
(FRONSTIM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a brain implant that sends electrical signals to help people with a specific type of dementia that causes severe symptoms like apathy. The goal is to see if this treatment can improve their brain function and reduce symptoms.
Will I have to stop taking my current medications?
The trial requires that participants have been on a stable dose of their current FTD medications for at least 3 months, so you won't need to stop taking them.
Is deep brain stimulation generally safe for humans?
Deep brain stimulation (DBS) has been studied for various conditions, including Parkinson's disease and Alzheimer's disease. While some adverse events (side effects) have been reported, such as cognitive and psychiatric changes, infections, and the need for additional surgeries, these are generally not severe, and the procedure is considered to have an acceptable safety profile in humans.12345
How is Bilateral subgenual cingulate deep brain stimulation (SGC DBS) different from other treatments for frontotemporal dementia?
SGC DBS is unique because it involves implanting electrodes in the brain to deliver electrical impulses, which is different from traditional drug treatments. This approach is experimental and has been used in other conditions like severe depression, focusing on specific brain areas to potentially alter mood and behavior.678910
What data supports the effectiveness of the treatment Bilateral subgenual cingulate deep brain stimulation (SGC DBS) for Frontotemporal Dementia?
Deep brain stimulation (DBS) has shown potential in treating cognitive and memory issues in Alzheimer's disease, with some studies suggesting it may slow disease progression and improve brain activity. While specific data for Frontotemporal Dementia is limited, the safety and potential benefits observed in Alzheimer's and Parkinson's disease provide some hope for its effectiveness in other dementias.411121314
Who Is on the Research Team?
Carmela Tartaglia, MD
Principal Investigator
University Health Network, Toronto
Andres M Lozano, MD, PhD
Principal Investigator
University Health Network, Toronto
Cletus Cheyuo, MD, PhD
Principal Investigator
University Health Network, Toronto
Are You a Good Fit for This Trial?
This trial is for adults aged 40-85 with behavioral variant frontotemporal dementia, showing symptoms like apathy. They must have stable medication use for the past 3 months and a caregiver or decision-maker to consent. Exclusions include pregnancy, substance dependence, other major CNS diseases, past significant brain surgery, MRI contraindications like metal implants, and conditions making anesthesia risky.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-Surgery Baseline Assessment
Baseline neuroimaging, neuropsychological testing, and biomarker assessments are conducted before DBS surgery
Surgery and Initial Recovery
Bilateral subgenual cingulate deep brain stimulator implantation and initial recovery
Post-Surgery Programming and Monitoring
DBS device activation and programming sessions to optimize therapy, along with regular neuropsychological and biomarker assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bilateral subgenual cingulate deep brain stimulation (SGC DBS)
Bilateral subgenual cingulate deep brain stimulation (SGC DBS) is already approved in United States, European Union for the following indications:
- Parkinson's disease
- Essential tremor
- Dystonia
- Obsessive-compulsive disorder
- Medically refractory epilepsy
- Parkinson's disease
- Essential tremor
- Dystonia
- Obsessive-compulsive disorder
- Medically refractory epilepsy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor
Weston Brain Institute
Collaborator