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Deep Brain Stimulation for Frontotemporal Dementia (FRONSTIM Trial)
N/A
Recruiting
Led By Andres M Lozano, MD, PhD
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
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
FRONSTIM Trial Summary
This trial will study the use of deep brain stimulation to treat Frontotemporal Dementia (FTD), the most common type of dementia in young patients, for which there is currently no cure.
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.Check my eligibility
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.See study design
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.
FRONSTIM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a specific type of dementia affecting behavior.
Select...
I am between 40 and 85 years old.
Select...
I experience a lack of interest or enthusiasm.
FRONSTIM Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-related Adverse Events
Secondary outcome measures
Apathy Evaluation Scale - Clinician version (AES-C)
Cerebrospinal fluid biomarkers of neurodegeneration (GFAP and NfL)
Free and Cued Selective Reminding Test (FCSRT)
+8 moreFRONSTIM 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.
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Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,475 Previous Clinical Trials
485,084 Total Patients Enrolled
1 Trials studying Frontotemporal Dementia
100 Patients Enrolled for Frontotemporal Dementia
Weston Brain InstituteOTHER
11 Previous Clinical Trials
967 Total Patients Enrolled
1 Trials studying Frontotemporal Dementia
112 Patients Enrolled for Frontotemporal Dementia
Andres M Lozano, MD, PhDPrincipal InvestigatorUniversity Health Network, Toronto
2 Previous Clinical Trials
21 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman who could become pregnant and am not using effective birth control.I have had major brain surgery in the past.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.I have been diagnosed with a psychiatric condition.You cannot have an MRI scan if you have certain metal implants in your body, or if you feel very uncomfortable in tight spaces.My doctor thinks anesthesia and surgery are too risky for me.My dementia medication dose has been stable for 3 months.You have been dependent on alcohol or illegal drugs in the past year.I need regular MRI scans for my medical condition.I do not have a major brain condition affecting my movement, feeling, or thinking.I am between 40 and 85 years old.I experience a lack of interest or enthusiasm.I need chemotherapy for my cancer or I'm on long-term steroids.
Research Study Groups:
This trial has the following groups:- Group 1: Bilateral subgenual cingulate deep brain stimulation (SGC DBS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the protocol of this experiment include individuals older than 35?
"The necessary age range for eligibility on this trial is 40 to 85 years old."
Answered by AI
What is the sample size of participants being treated in this research?
"Indeed, the information found on clinicaltrials.gov reports that this trial is presently scouting for participants. This research project was initially publicized on December 12th 2023 and most recently refreshed on January 16th 2023. The study necessitates six individuals to be recruited from a single medical facility."
Answered by AI
Are any new participants being enrolled for this clinical trial?
"Affirmative. Clinicaltrials.gov data affirms that this investigation, which was initially posted on December 1st 2023, is actively seeking participants. 6 people need to be enrolled from a single medical facility."
Answered by AI
Would I be considered a suitable participant for this experiment?
"This medical trial is recruiting 6 individuals aged between 40 and 85 with a diagnosis of frontotemporal dementia. The prerequisites for participation include being male or female, having apathy as one of the symptoms, maintaining a stable dose of FTD medications for 3 months prior to enrolment, possessing an available caregiver who can accurately report on daily activities and function, plus having a substitute decision maker (if different from the primary caregiver) that agrees to sign informed consent documents."
Answered by AI
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