6 Participants Needed

Deep Brain Stimulation for Frontotemporal Dementia

(FRONSTIM Trial)

CC
TH
Overseen ByTasnuva Hoque
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University Health Network, Toronto
Must be taking: FTD medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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.

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.12345

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.16789

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.1011121314

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.

Research Team

M Carmela Tartaglia | UHN Research

Carmela Tartaglia, MD

Principal Investigator

University Health Network, Toronto

AM

Andres M Lozano, MD, PhD

Principal Investigator

University Health Network, Toronto

CC

Cletus Cheyuo, MD, PhD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

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

I have been diagnosed with a specific type of dementia affecting behavior.
I have someone who can reliably report on my daily activities and function.
The patient must also have a substitute decision maker, if different from caregiver, to sign the informed consent for participation in the study
See 3 more

Exclusion Criteria

Is unable to comply with study visit schedule and timeline
I am a woman who could become pregnant and am not using effective birth control.
I have had major brain surgery in the past.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Baseline Assessment

Baseline neuroimaging, neuropsychological testing, and biomarker assessments are conducted before DBS surgery

4 weeks
Multiple visits (in-person)

Surgery and Initial Recovery

Bilateral subgenual cingulate deep brain stimulator implantation and initial recovery

2 weeks
Inpatient stay for surgery and recovery

Post-Surgery Programming and Monitoring

DBS device activation and programming sessions to optimize therapy, along with regular neuropsychological and biomarker assessments

24 months
Regular visits at 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months
Regular follow-up visits

Treatment Details

Interventions

  • Bilateral subgenual cingulate deep brain stimulation (SGC DBS)
Trial Overview The study tests deep brain stimulation of the subgenual cingulate to treat frontotemporal dementia symptoms by activating dysfunctional networks in the brain. It will monitor changes in cerebral metabolism, connectivity, atrophy and biomarkers to evaluate safety and preliminary effectiveness.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Bilateral subgenual cingulate deep brain stimulation (SGC DBS)Experimental Treatment1 Intervention
Deep Brain Stimulation (DBS) is a neurosurgical procedure involving the implantation of deep brain electrodes, connected via a subcutaneous extension wire, to an implantable pulse generator (IPG, or 'battery') that is implanted below the collarbone. All patients will receive deep brain stimulation (DBS) targeting the subgenual cingulate (SGC) bilaterally. No other changes to pre-existing treatment will be made. This is the only arm in this experiment.

Bilateral subgenual cingulate deep brain stimulation (SGC DBS) is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Deep Brain Stimulation for:
  • Parkinson's disease
  • Essential tremor
  • Dystonia
  • Obsessive-compulsive disorder
  • Medically refractory epilepsy
🇪🇺
Approved in European Union as Deep Brain Stimulation for:
  • 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

Trials
1,555
Recruited
526,000+

Weston Brain Institute

Collaborator

Trials
13
Recruited
990+

Findings from Research

Deep brain stimulation (DBS) therapy for Alzheimer's disease (AD) and Parkinson's disease dementia (PDD) has been explored in 7 clinical studies involving 57 AD patients and 7 PDD patients, showing acceptable surgical safety with serious adverse events occurring in only 9% of patients, none resulting in death or disability.
While some individual cases reported improved clinical responses to DBS, larger studies did not find significant or consistent cognitive benefits, indicating that more research is needed to refine patient selection and treatment parameters for effective outcomes.
Deep brain stimulation for dementias.Xu, DS., Ponce, FA.[2020]
Deep brain stimulation (DBS) has been explored as a treatment for dementia, with three studies focusing on its effects, including one on fornix DBS for Alzheimer's disease and two on nucleus basalis of Meynert for Alzheimer's and Parkinson's disease dementia.
Current evidence for the effectiveness of DBS in treating dementia is still preliminary and limited, indicating a need for further research to understand its potential clinical benefits.
Deep brain stimulation for the treatment of Alzheimer disease and dementias.Laxton, AW., Lozano, AM.[2022]
Deep brain stimulation (DBS) targeting the fornix shows promise in potentially slowing cognitive decline and improving brain health in patients with mild Alzheimer's disease, with ongoing phase III trials to assess its efficacy.
DBS may offer disease-modifying effects rather than just symptomatic relief, as seen in animal studies that suggest it can enhance neuroprotection and influence the progression of neurodegenerative disorders.
Modifying the progression of Alzheimer's and Parkinson's disease with deep brain stimulation.Jakobs, M., Lee, DJ., Lozano, AM.[2021]

References

Deep brain stimulation for dementias. [2020]
Deep brain stimulation for the treatment of Alzheimer disease and dementias. [2022]
Modifying the progression of Alzheimer's and Parkinson's disease with deep brain stimulation. [2021]
Cholinergic Deep Brain Stimulation for Memory and Cognitive Disorders. [2023]
Increased cerebral metabolism after 1 year of deep brain stimulation in Alzheimer disease. [2021]
Multicenter study on deep brain stimulation in Parkinson's disease: an independent assessment of reported adverse events at 4 years. [2008]
Surgical adverse events of deep brain stimulation in the subthalamic nucleus of patients with Parkinson's disease. The learning curve and the pitfalls. [2022]
Complications in subthalamic nucleus stimulation surgery for treatment of Parkinson's disease. Review of 272 procedures. [2019]
Bilateral deep brain stimulation of the fornix for Alzheimer's disease: surgical safety in the ADvance trial. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Autonomic arousal elicited by subcallosal cingulate stimulation is explained by white matter connectivity. [2019]
Deep brain stimulation of the subthalamic nucleus in Parkinson's disease: evaluation of active electrode contacts. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Impact of brain shift on subcallosal cingulate deep brain stimulation. [2021]
Multiple sequential image-fusion and direct MRI localisation of the subthalamic nucleus for deep brain stimulation. [2017]
[Analysis of antiparkinsonian drug reduction after bilateral subthalamic deep brain stimulation]. [2010]
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