What side effects are associated with this type of intervention?

Deep Brain Stimulation (DBS) for Frontotemporal Dementia (FTD) is still under investigation, and its side effects are not fully established. However, general side effects of DBS can include infection, bleeding, and hardware complications. Additionally, there may be neuropsychiatric side effects such as mood changes, apathy, or impulsivity. As with any neurosurgical procedure, there are risks associated with the surgery itself, including anesthesia-related complications.

What prior FDA approvals exist?

There are no FDA-approved treatments specifically for Frontotemporal Dementia (FTD) mentioned in the provided context. The document highlights the use of Deep Brain Stimulation (DBS) targeting the subgenual cingulate (SGC) as a potential treatment for the behavioral variant of FTD, focusing on modulating dysfunctional networks to improve symptoms. However, this approach is still under investigation and not yet approved by the FDA.

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Device

Deep Brain Stimulation for Frontotemporal Dementia (FRONSTIM Trial)

Q: What other types of research exist?

Promising novel alternatives to Deep Brain Stimulation for Frontotemporal Dementia patients include transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS). Both techniques have shown potential in modulating brain activity and improving symptoms in various neurodegenerative and psychiatric conditions.

N/A

Recruiting

Led By Carmela Tartaglia, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of image-supported behavioral variant frontotemporal dementia according to NIC-FTD and NACC FTLD guidelines

Men and women aged 40-85 years

Must not have

A female lactating or of child-bearing potential, with a positive pregnancy test or not using adequate contraception

Past significant intracranial surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline before dbs surgery, and at 3-months, 6-months, 12-months and 24-months post-dbs surgery

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from the device implantation procedure, headache or pain at the implant site post-surgery; risk of infection; possible changes in mood or behavior due to stimulation; and general risks associated with anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a specific type of dementia affecting behavior.

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I am between 40 and 85 years old.

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I experience a lack of interest or enthusiasm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a woman who could become pregnant and am not using effective birth control.

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I have had major brain surgery in the past.

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I have been diagnosed with a psychiatric condition.

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I need regular MRI scans for my medical condition.

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I do not have a major brain condition affecting my movement, feeling, or thinking.

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I need chemotherapy for my cancer or I'm on long-term steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline before dbs surgery, and at 3-months, 6-months, 12-months and 24-months post-dbs surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline before dbs surgery, and at 3-months, 6-months, 12-months and 24-months post-dbs surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline before dbs surgery, and at 3-months, 6-months, 12-months and 24-months post-dbs surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment-related Adverse Events

Secondary study objectives

Apathy Evaluation Scale - Clinician version (AES-C)

Cerebrospinal fluid biomarkers of neurodegeneration (GFAP and NfL)

Free and Cued Selective Reminding Test (FCSRT)

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Deep Brain Stimulation (DBS) for Frontotemporal Dementia (FTD) targets the subgenual cingulate (SGC) to modulate its downstream projections, which are crucial for cognitive and behavioral functions. By stimulating the SGC, DBS aims to enhance activity in dysfunctional neural networks, reverse hypometabolism, and potentially improve symptoms such as apathy, disinhibition, and loss of executive function. This approach matters for FTD patients as it addresses the core pathophysiological disruptions in brain connectivity and metabolism, offering a potential avenue for symptom relief and improved quality of life.

DLPF Targeted Repetitive Transcranial Magnetic Stimulation Improves Brain Glucose Metabolism Along with the Clinical and Electrophysiological Parameters in CBD Patients.Application of subject-specific helmets for the study of human visuomotor behavior using transcranial focused ultrasound: a pilot study.Non-invasive and invasive brain stimulation in alcohol use disorders: A critical review of selected human evidence and methodological considerations to guide future research.