FRONSTIM

Interventional Study

Get in touch about this study

Full Study Title: 

Subgenual Cingulate Deep Brain STIMulation for Apathetic Behavioral Variant FRONtotemporal Dementia (FRONSTIM)

 

What is the study about?

This is a 3-year study designed to evaluate the safety of deep brain stimulation (DBS) of the subgenual cingulate (SGC) in subjects diagnosed with behavioral variant frontotemporal dementia (FTD). In addition, the physiological and clinical effects of DBS will be assessed by neuroimaging and neuropsychological testing.

 

Eligibility- Who can participate?

Participants must:

  • Be 40-85 years of age
  • Been diagnosed with behavioural variant frontotemporal dementia
  • Have apathy as one of the symptoms
  • Have a reliable study partner who can provide information on the participant’s behaviour, thinking and functioning

 

Time requirement

Participants will go through 3 phases of the study:

Pre-Operative Phase will include a screening visit (3.5 hours) and a baseline visit (4 hours) on two separate days.

Operative Phase will be comprised of two stages: Surgery (3-5 hours) and Hospitalization (participants can expect to be in the hospital after surgery for approximately 1-2 days)

Post-Operative Phase will include a follow up visit 10-12 days after surgery where the DBS device will be turned on. This will last about 40 minutes. After the device is turned on, participants will return to the hospital at 1, 2, 3, 6, 12 and 24 months post surgery to adjust stimulation and review any side effects. These visits can last from 40 minutes to 2 hours maximum.

 

TDRA study investigator

Dr. Andres M. Lozano (neurosurgeon)

Dr. Carmela Tartaglia (neurologist)

 

Video

Advances in Dementia Research Webinar- Listen to Dr. Andres Lozano (co-Principal Investigator) discuss the FRONTSIM study in further detail: https://youtu.be/-nIyA_1whYk

More Information

https://clinicaltrials.gov/ct2/show/NCT05699330

 

TDRA Site:

University Health Network (UHN)-Toronto Western Hospital,

Address: 399 Bathurst Street, Toronto ON M5T 2S8

Age Group:

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Target Population:

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Disclaimer

The listing of a study on the Toronto Dementia Network (TDN) is for informational purposes only. The safety, efficacy or scientific validity of the studies listed here have not been evaluated by The Alzheimer Society of Toronto (AST) or the Toronto Dementia Research Alliance (TDRA). The TDRA is an academic coalition among the University of Toronto and four memory clinics across Toronto at Baycrest, the Centre for Addiction and Mental Health, Sunnybrook Health Sciences Centre, and the University Health Network. The information collected will be kept and guarded by TDRA. Choosing to participate in a study is an important personal decision. Before you participate in a study, you should make sure you understand the risks and potential benefits and discuss all options with your health care provider(s).